Anthrax is a serious infectious disease caused by the bacteria Bacillus anthracis. People or animals can contract anthrax from contact with infected animals or contaminated animal products. Bacillus anthracis forms spores than can survive in the environment, especially soil or animal products (e.g., rawhide) for decades. The most common route of exposure is via skin scrapes when working with infected animals resulting in cutaneous anthrax. Gastrointestinal infection occurs following eating raw or undercooked infected or contaminated meat. The most dangerous form of anthrax follows after inhalation of aerosolized anthrax spores, typically during industrial processing of infected animal products (e.g., rawhide, wool). In the United States, anthrax is very rare. Vaccination of livestock is recommended in areas with historical occurrences of anthrax. Moreover, all food animals are examined before slaughter (Mayo Clinic, Guide to Understanding Anthrax, ACIP).
Anthrax spores had been mass-produced as a bioweapon by the Soviet Union (STAT News). In 2001, anthrax was also used as a bioweapon when letters laced with anthrax were mailed to several news media offices and Democratic Senators Tom Daschle and Patrick Leahy, killing five and sickening 17 (Amerithrax investigation). Anthrax vaccine BioThrax is given to adults at increased risk of exposure in five doses, with a booster dose each year. It is also used as post-exposure prophylaxis in combination with antibiotics.
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Adenoviruses commonly cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, but also gastroenteritis, conjunctivitis, cystitis, or neurological disease. Adenoviruses have been a common cause of acute respiratory illness in military recruits. As non-enveloped viruses, adenoviruses are relatively resistant to common disinfectants. There are more than 50 types of immunologically distinct adenoviruses. People with weakened immune systems are at high risk of developing a severe disease caused by adenovirus infection (CDC, Health.mil). The vaccine is mandatory for all enlisted military recruits (Army Regulation 40-562).
Vaccine: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (US)
This PPT comprises of brief history of vaccines and its details, concentrated on adverse reactions due to various vaccines, and briefly bout the cold chain.
INTRODUCTION OF VACCINE & VACCINATION.
HISTORY.
TYPRE OF VACCINE
CONTRAINDICATION.
CLASSIFICATION ACCORDING TO PATHOGEN.
PRECAUTION BEFORE TO VACCINE.
DRUGS ADMINISTRATION -: ROUTES & DOSE
SUMMARY.
REFERENCES.
ASSESSMENT QUESTIONS
Adenoviruses commonly cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, but also gastroenteritis, conjunctivitis, cystitis, or neurological disease. Adenoviruses have been a common cause of acute respiratory illness in military recruits. As non-enveloped viruses, adenoviruses are relatively resistant to common disinfectants. There are more than 50 types of immunologically distinct adenoviruses. People with weakened immune systems are at high risk of developing a severe disease caused by adenovirus infection (CDC, Health.mil). The vaccine is mandatory for all enlisted military recruits (Army Regulation 40-562).
Vaccine: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (US)
This PPT comprises of brief history of vaccines and its details, concentrated on adverse reactions due to various vaccines, and briefly bout the cold chain.
INTRODUCTION OF VACCINE & VACCINATION.
HISTORY.
TYPRE OF VACCINE
CONTRAINDICATION.
CLASSIFICATION ACCORDING TO PATHOGEN.
PRECAUTION BEFORE TO VACCINE.
DRUGS ADMINISTRATION -: ROUTES & DOSE
SUMMARY.
REFERENCES.
ASSESSMENT QUESTIONS
Most developments in biotechnology originated for their potential applications in health care.
Contributions of biotechnology are more frequent, more notable and more rewarding in health sector.
vaccine is a biological preparation that provides active acquired immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future.
HISTORY OF VACCINES-
EDWARD JENNER conduct experiments in 1796 that lead to the creation of the first smallpox vaccine for prevention of smallpox.
A vaccine for RABIES is developed by LOUIS PASTEUR .
Vaccine for COLERA and TYPHOID were developed in 1896 and PLAGE vaccine in 1887.
The first DIPHTHERIA vaccine is developed in about 1913 by EMIL ADOLPH BEHRING,WILLIAM HALLOCK PARK.
The whole cell PERTUSIS vaccines are developed in 1914.
A TETANUS vaccine is developed in 1927.
What are Vaccines and How Vaccines are DevelopedPlanet Ayurveda
Vaccines are the talk of the world right now. Some of us have got them and the rest of us are thinking of when and how to get them. You might have heard that getting vaccinated brings you some after-effects like nausea and fever. Some doubtful discussions might also be going around the trustability of newly developed vaccines. What do the vaccines contain? Have you thought about it yet? How do they work? Answers to all such questions are given in this Presentation, watch and add something very precious to Your Knowledge from the Treasure of Planet Ayurveda.
"edible vaccines": Vaccines or candidate vaccines derived from edible plants. Transgenic plants are used as recombinant protein production systems and the edible plant tissue functions as an oral vaccine.
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...Arete-Zoe, LLC
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
Most developments in biotechnology originated for their potential applications in health care.
Contributions of biotechnology are more frequent, more notable and more rewarding in health sector.
vaccine is a biological preparation that provides active acquired immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future.
HISTORY OF VACCINES-
EDWARD JENNER conduct experiments in 1796 that lead to the creation of the first smallpox vaccine for prevention of smallpox.
A vaccine for RABIES is developed by LOUIS PASTEUR .
Vaccine for COLERA and TYPHOID were developed in 1896 and PLAGE vaccine in 1887.
The first DIPHTHERIA vaccine is developed in about 1913 by EMIL ADOLPH BEHRING,WILLIAM HALLOCK PARK.
The whole cell PERTUSIS vaccines are developed in 1914.
A TETANUS vaccine is developed in 1927.
What are Vaccines and How Vaccines are DevelopedPlanet Ayurveda
Vaccines are the talk of the world right now. Some of us have got them and the rest of us are thinking of when and how to get them. You might have heard that getting vaccinated brings you some after-effects like nausea and fever. Some doubtful discussions might also be going around the trustability of newly developed vaccines. What do the vaccines contain? Have you thought about it yet? How do they work? Answers to all such questions are given in this Presentation, watch and add something very precious to Your Knowledge from the Treasure of Planet Ayurveda.
"edible vaccines": Vaccines or candidate vaccines derived from edible plants. Transgenic plants are used as recombinant protein production systems and the edible plant tissue functions as an oral vaccine.
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...Arete-Zoe, LLC
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
Sexual assault cases regularly make headlines and can potentially cause serious reputational harm to law enforcement agencies and police departments for mishandling the cases or not pursuing them vigorously enough.
The picture on the left shows the latest developments in a long-term problem of sexual assault on college campuses. In June, Candice Johnson, OCR Acting Assistant Secretary for Civil Rights issued a memo that effectively stalled investigation of civil rights violations including sexual assault on campuses. A month later, Democratic Senators Kirsten Gillibrand from New York State and Claire McCaskill from Missouri urged Secretary of Education Betsy Devos to reverse this decision as unlawful because of failure to protect students under Title IX. Full text of the memo and Title IX, Sec. 1681 Sex are part of your lesson handout.
Similar problem with widespread sexual assault, and especially against minors, is a long-term problem at cruise ships. Because of the nature of cruise ships, there is no immediate response by law enforcement and the ship guards that investigate the matter are the cruise company’s employees therefore often unlikely to be of meaningful help to the victims. Jurisdiction can be federal, state or foreign, depending on the ship’s flag.
Finally, sexual violence in a workplace can be difficult to address because of the unequal relationship between parties and under-reporting. Recently, car company Tesla appeared in the news as a hostile workplace to women.
Mitigating consequences of a drug-facilitated sexual assault .pdfArete-Zoe, LLC
Mitigating consequences of a drug-facilitated sexual assault
First published: 27 Jan 2017
Revised: 19 Jan 2020
Drug-facilitated sexual assault (DFSA) is not just bad sex. It occurs either without the victim’s consent or with consent that cannot be considered valid due to incapacitation of the victim by alcohol or drugs. While opportunistic DFSA is carried out once the victim has been rendered unconscious by own actions, pro-active DFSA describes situations when the perpetrator spikes the victim’s drinks covertly.
The most frequently used drug in DFSA is alcohol. Other drugs often involved include flunitrazepam (Rohypnol), gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), carisoprodol (Soma) and ketamine. Ecstasy (MDMA) and other benzodiazepines are occasionally used also. These drugs rapidly induce drowsiness, sedation and muscle relaxation. Typical symptom is decreased inhibition. Most of the drugs used for DFSA are odorless and tasteless, with the exception of GBL that has a bitter taste. Memoryy loss is common, most victims have little to no recollection of the previous night.
The most common way of obtaining these drugs is through the darknet. Benzodiazepines, GHB (Xyrem), and ketamine (an anesthetic used in human and veterinary medicine) are often diverted from legitimate medical use for illicit purposes.
In 2012, in U.S. v. Caronia became one of the landmark cases in the promotion of prescription drugs for unapproved (off-label) indications. Physicians who prescribe Xyrem (GHB) have to pass special certification to ensure safe prescription, handling, and storage of the drug (REMS).
Sedative or tranquilizer Flunitrazepam is still legally manufactured in Europe and some countries in Latin America. The drug has been reformulated, so it imparts an easily identifiable blue color to clear beverages and haziness to colored drinks. Drugs obtained from illegal manufacturing sources naturally do not display this effect.
DFSAs are increasingly popular in bars, clubs, and raves, but also fraternities and at college campuses. Mishandling of cases of sexual assault at college campuses has been subject to much criticism.
It is very difficult to estimate the total number of DFSAs. The main reason for failure to report sexual assault is the reluctance of the victims to go to the police. Indications exist that the numbers are on the increase. Because of memory loss associated with these drugs, victims often feel embarrassed or guilty. Additional reasons for not reporting sexual assault include need to avoid further stigmatization, especially when the evidence does not seem to be sufficient to support the claim confidently. Forensic evidence is difficult to obtain and often lost after first urination the morning after. All drugs used for DFSA are metabolized rapidly by the body, rendering them undetectable within 24 to 48 hours after ingestion.
Approach to preparing for a biological attack (2017)Arete-Zoe, LLC
Approach to preparing for a biological attack
June 2017
Hospital risk management series
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
Improving the resilience of vulnerable populationsArete-Zoe, LLC
Vulnerable populations in terms of health care disparities include the economically disadvantaged and uninsured, the elderly, and people with chronic health conditions. Low-education status compounds the problem and leads to poorer outcomes than in people with the same disease but higher educational status. Significant disparities include namely risk factors relating to morbidity and mortality and access to healthcare. In the domain of physical health, the worst affected are people with chronic health conditions such as respiratory diseases and metabolic syndrome, including hyperlipidemia and diabetes, and resulting in heart diseases and hypertension. Vulnerable populations often experience accumulation of problems that are multiplied by poor health, yet the medical and non-medical needs of these populations are still underestimated. A significant number of vulnerable people with at least one chronic condition skip purchasing prescription drugs because of the costs involved. The most relevant risk factors that result in poor access to health care include low income and uninsured status, in combination with a lack of regular care. Chronic conditions such as dyslipidemia may not be particularly apparent now, yet represent a high risk of future disability (“Vulnerable Populations: Who Are They?”, 2006).
Medical innovation, increasing the complexity of care, and the relationships between stakeholders gradually lead to the increase in prices of healthcare for consumers. Lack of transparency affects the cost of premiums as well as out-of-pocket expenses. Policymakers in their considerations need to include more indicators than just insurance coverage that, without other measures, will not curb soaring healthcare expenses. Delayed care is a public health concern because of the risk of disability and under-treatment of otherwise treatable conditions. The presentation of data to non-technical audiences, including decision-makers, has to be understandable to convey the information reliably. Systems modeling techniques should be considered to estimate stakeholder behavior in a dynamic system accurately. Currently, many instances of abuse exist within the system. As an example, chargemaster fees apply to uninsured or out-of-network patients. Hospital fees are, however, tackled by state laws rather than at the federal level. Consumers in health care tend to behave differently than in other industries and often think less about the costs involved. Physicians’ education should include the delivery of cost-conscious care to prevent financial harm to their patients. Transparency of cost is one of the most effective mechanisms that enable patients and providers to make informed choices.
Handling a high-risk HIPAA Breach Published April 2017 Part of scenarios for patient privacy crisis management Every hospital encounters patients, who for the reason of their social circumstances, dependent status, personal characteristics, or the nature of their condition, are more vulnerable than the general population. While compliance with HIPAA is indeed important, because of the potential to inflict significant liability on the hospital resulting from compliance failure, it should not be the only consideration when caring for vulnerable patients. Mere compliance with the minimum requirements of HIPAA does not guarantee the safety of vulnerable patients. In the case study scenario, the hospital emergency department in a small town admitted a 15-year-old female with emergency labor. After delivery in the emergency room, the mother and the baby were moved to Obstetrics and Neonate. Despite appropriate care, the infant presented with multiple medical problems, which may or may not be resolved in the future. A nurse, who took care of the young mother, accidentally disclosed the patient’s identity and condition to her young daughter, who spread the news in all high schools in the area by the following day. The 15-year-old managed to hide her pregnancy from her family. To complicate matters, the young mother’s mother and aunt work in the same hospital.
Addressing pediatric medication errors in ED setting utilizing Computerized P...Arete-Zoe, LLC
Pediatric patients who are treated in general acute care hospitals are at increased risk of medication errors. The main reasons are the lack of experience with the special needs of pediatric patients, their lower ability to tolerate medication errors, medication-related problems such as forms and packaging designed primarily for adults and labeling with insufficient information on the dosing of pediatric patients. Medication errors can be reduced significantly by appropriate medication management systems. Computerized Provider Order Entry (CPOE) systems reduce the frequency of medication errors in all stages of the process. IT technology introduces an additional vulnerability in the form of IT-related medication errors. Nurses are the last individuals in the medication management process who can detect and intercept a medication error and prevent incorrect medication orders from reaching and harming their patients. To be able to do so, nurses have to be familiar with the medication management system in their hospital and escalate incorrect orders as appropriate and relevant.
Let's talk causality attribution: Current practices and path forward Arete-Zoe, LLC
Consistent and reliable causality attribution at the case level is the cornerstone of confident signal detection.
The current practice relies on study investigators to establish causal relationships based on their observations. The Sponsor (Company) can add their assessment based on additional information about the drug. The current industry standard, E2B (R3), accounts for multiple assessment methods and presents the data elements for each drug-event pair evaluated by multiple sources in a matrix.
There are many causality assessment methods used within the industry, some universal, others more specialized. Most commonly used methods include WHO-UMC, Naranjo, Roussel-Uclaf (RUCAM) - to detect drug-associated liver injury, Karch and Lasagna, the French PV Algorithm, Bayesian Adverse Reactions Diagnostic Instrument (BARDI), MacBARDI, and Updated Logistic method. Expert judgment remains the most common method used.
Serious challenges prevent the practical implementation of existing algorithms by the industry. Many of the algorithms cannot be applied rigorously because of missing data. Additionally, an accurate definition of clinical harm is often lacking (e.g., peripheral neuropathy, vasculitis). Brighton Collaboration Case Definitions partly address this component.
Algorithms do not consider medication errors and are not easy to use with interactions, contributory causation, or secondary harms. Information obtained from the reporter is usually insufficient to establish a causal relationship, and follow-up requests for information must be sent, often repeatedly. The result is a very high share of unassessable reports and poor internal consistency of existing assessments.
I suggest modifying the ADE reporting to incorporate components enabling structured causality assessment directly by the reporting physician (postmarket) or investigator (clinical trials). Guiding questions would assist the reporting physician in determining causal relationships and facilitate algorithmic attribution upon submission:
Temporal relationship is a key component of causality assessment. Safety databases routinely calculate latency and last dose latency that feed the algorithm.
Dechallenge and Rechallenge represent key concepts in pharmacovigilance. This information is typically missing from reports. A series of questions regarding Outcome and Response (Action taken with drug) guide the reporting physician through a checklist for all suspect and interacting drugs, reliably and consistently calculating dechallenge/rechallenge for each drug-event pair.
Biological plausibility is a complex component requiring knowledge of the drug and the patient's medical condition.
Finally, it is important to ask the reporting physician about any underlying diseases that could have contributed to the event. A clear answer to this question is an essential component of the causality assessment algorithms.
Clinical documentation for medical devices Arete-Zoe, LLC
Clinical documentation for medical devices
Medical Devices Regulation (EU) 2017/745
We prepare EU MDR-compliant clinical documentation for medical device manufacturers for submission to notified bodies and national regulatory authorities.
EU MDR-compliant clinical documentation (English, Czech):
- Clinical evaluation (plan, report)
- Post-Market Clinical Follow-Up, -
- PMCF (plan, report, study design)
- Post-Market Surveillance System (plan, report)
- Clinical investigation design to complement existing evidence
- Biological Evaluation
- Literature review
Consulting
- Strategy how to generate clinical evidence
- Design of PMCF studies and clinical investigations
Additional support:
- Clinical expert for multiple medical specialties
- Risk management specialist
- Technical documentation
Zpracování klinické dokumentace dle EU MDR 2017/745 Arete-Zoe, LLC
Zpracování klinické dokumentace dle EU MDR 2017/745
- Strategie generování klinického důkazu
- Zpracování klinické dokumentace
- Design PMCF studií a zkoušek
- Návrhy aktualizací existující dokumentace
Služby
Poradenství
Strategie generování klinického důkazu
Design PMCF studií a zkoušek
Zpracování klinické dokumentace (ČJ, AJ)
Klinické hodnocení (plán/zpráva)
PMCF, PMS (plán/zpráva), PSUR
Biologické hodnocení
Návrh aktualizace související dokumentace
Stavba týmu dle potřeb zákazníka:
Klinický expert relevantní pro daný lékařský obor
Specialista na management rizika
Laboratoř na testování software, včetně AI/ML
Zpracování ostatních částí technické dokumentace
Klinické hodnocení (Plán, Zpráva)
Protokol literární rešerše
Biologické hodnocení
Post-Market Clinical Follow-Up (PMCF) (Plán, Zpráva)
Post-Market Surveillance (PMS) (Plán, Zpráva)
Periodic Safety Update Report (PSUR)
Pharmacovigilance Workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
Case studies:
Mylotarg (Gemtuzumab ozogamicin): no benefit, risk of death
Roaccutane (isotretinoin): teratogenic effect
Lariam (mefloquine): neuropsychiatric side effects
Zyprexa (olanzapine): stroke in patients with dementia
Avandia (rosiglitazone): myocardial infarction, death due to cardiovascular causes
Seroxat (paroxetine): suicidality
Xyrem (sodium oxybate): diversion, abuse
Coumadin (warfarin): bleeding
https://www.aretezoe.com/pharmacovigilance-workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
https://www.aretezoe.com/pharmacovigilance-workshop
Published April 2017
Part of hospital test scenarios, escalation to ethics committee
Patients with a terminal illness who communicate their wish to die to a nurse shall receive appropriate care that is in line with institutional procedures, local laws, and their personal preferences. A nurse should be able to rely on the support of the institution he or she works for in terms of training, clear line of responsibility for such decisions, and unambiguously communicated expectations defined in organizational procedures. Assisted suicide is legal in Switzerland and several other European countries, in several states in the U.S., and in Canada. The mental capacity of the patient has to be considered in addition to locally applicable laws. Medical Power of Attorney is helpful if the patient previously described his or her wishes regarding end-of-life decisions and became incapacitated in the meantime. Financial toxicity, in addition to dubious effectiveness, contributes to the reluctance of some patients to undergo aggressive and invasive therapies. German physician Albert Moll in his book Medical Ethics (1902), argues that aggressive care in incurably ill patients is unethical. Healthcare staff, including nurses, can conscientiously object to assisting with suicide.
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention (2017)Arete-Zoe, LLC
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention
First published April 2017
Part of test scenarios for implementation of new sepsis guidelines
Why merging medical records, hospital reports, and clinical trial data is a v...Arete-Zoe, LLC
Medical privacy and breaches of personal health information (PHI) has been a hot topic for several years. For the clinical trial industry, the main concerns are decline in recruitment resulting from lack of confidence in data handling and instances of breaches that affect data integrity that adversely affect NDA and MA applications in major markets, which precipitates administrative action taken by national regulators in response to local incidents.
European legislators rely extensively on administrative measures implemented by national competent authorities. Although specific and detailed EU-level legislation exists, specific information about data breaches, cases and incidents, volume and type of affected data, root causes and analysis of consequences is largely missing. According to Howard and Gulyas (2014), this lack of organized event records is currently an empirical obstacle but provides opportunity to generate new knowledge about data and privacy protection that could bolster future trial recruitment.
In the U.S., summary details of breaches that involved more than 500 individuals are available at the OCR portal called Wall of Shame for everyone to analyze. Disclosure obligations in HIPAA made the problem of data breaches in healthcare obvious and protection of the privacy of patients has been an important part of physicians’ code of conduct. This offers lessons learned to mitigate systemic vulnerabilities that undermine trial participation.
Obesity in adults is defined as having a body mass index (BMI) of 30 or more, while overweight stands for BMI between 25 and 30 (Baker, 2017). BMI, adjusted for age and gender, is used to measure obesity in children, taking into account different growth patterns among boys and girls for each age group. The British 1990 growth reference (UK90) serves as the growth standard. The threshold is 85th percentile for overweight and 95th percentile for obese. The increase in BMI was observed in both genders (The Health and Social Care Information Centre, 2013). At present, nearly a third of UK children are either overweight or obese. Children with excess weight are more likely to become overweight adults and suffer from a range of related ailments such as type-2 diabetes, heart disease, and depression. Excess weight is linked to academic underachievement and economic deprivation, as well as increased costs on the public social and welfare systems (Department of Health, 2017).
https://aretezoe.com/
Dark Side of a Mountain: Culture & Ideology in Medicine (2014) Arete-Zoe, LLC
Dark Side of a Mountain is a historical study into the effects of ideology, religion and culture on medical science. Section “The Code” is dedicated to the first public health manual on record: The Book of Leviticus, and to its 12th century annotation by Moses Maimonides. Causal relationship is found between rejection of food laws by early Christians, suppression of certain parts of the Bible by Catholic Church, measures against heretics, and resulting inability of medieval populations to contain plague which ravaged Europe in the 6th and 14th century. Truth table illustrates the causes and essential conditions of the Justinian plague and the 1348 plague. Essential conditions of the Justinian Plague were loss of autonomy, lowering standard of living including hygiene due to the onset feudalism, and strategic dependence of Byzantine Empire on imports of essential commodities from infected regions. The plague of 1348 brought about change of life-science doctrine to a set of religious dogmas. The argument goes that the root cause of the pandemic was a flawed life-science doctrine, which could not be challenged due to ideological and religious terror. Quest for heretics effectively eliminated all people who had the ability to identify correctly the causes of plague and who were able to suggest rational measures against its spread. This is presented in the context of information available at that time on the example of measures against leprosy as described in the Old Testament. Section Medical Oaths presents different concepts in medical ethics around the globe. The meaning of medical oath in ancient Greece was far less symbolic than it is now – it was a legal act. Today, medical profession is subject to regulations, which to a certain degree replace the need for formal recognition of an ethical code. Some ancient oaths paid lot of attention to then common practices of arranged marriages and witchcraft; and almost all banned abortion and euthanasia. Japanese medical ethics gets special attention, due to unique relationship between martial arts and the art of medicine. The oath of the school of Enjuin includes meditation over the link between Bushido Code and Japanese understanding of medical ethics, and brief excursion into Japanese medical research conducted in occupied territories during the WWII. https://www.amazon.com/Dark-Side-Mountain-Ideology-Medicine/dp/1468001132/
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
2. Gram-positive, rod-shaped bacteria,
forms endospores
Plasmides pXO1 and pXO2
responsible for pathogenicity
Synthesizes protein capsule that
disguises the vegetative bacterium
from the host immune system
ANTHRAX
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3. ANTHRAX
CUTANEOUS ANTHRAX:
Painless sore with a black center, swelling of regional lymph nodes, flu-like symptoms
GASTROINTESTINAL ANTHRAX:
Nausea, vomiting, abdominal pain, loss of appetite, fever, headache
Severe, bloody diarrhea, sore throat, swollen neck
INHALATION ANTHRAX:
Flu-like symptoms, chest discomfort,
Shortness of breath, coughing up blood, high fever, shock, meningitis
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4. AFFECTED POPULATION
ZOONOTIC TRANSMISSION
People handling livestock, animal carcasses or rawhide
Contact with contaminated soil or animal products
LABORATORY
Accidental exposure in specialized laboratories
WEAPONIZED ANTHRAX
Terrorist attacks, 2001 (Amerithrax investigation)
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6. VACCINETECHNOLOGY
Cell-free filtrate of microaerophilic cultures of an avirulent, non-encapsulated strain of Bacillus anthracis.
Grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins,
inorganic salts, and sugars.
The final product contains proteins, including the 83kDa protective antigen (PA) protein, released during
the growth period and contains no dead or live bacteria.
Contains 1.2 mg/mL aluminum (aluminum hydroxide in 0.85% sodium chloride), 25 mcg/mL
benzethonium chloride and 100 mcg/mL formaldehyde as preservatives.
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7. INDICATIONS & USAGE
INDICATIONS
Active immunization for the prevention of disease caused by Bacillus anthracis
Pre-exposure prophylaxis of disease in persons whose occupation or other activities place them at high risk
of exposure.
Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when
administered in conjunction with recommended antibacterial drugs.
The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of
inhalational anthrax.
POPULATION
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Persons 18 through 65 years of age.
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8. CONTRAINDICATIONS
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Severe Allergic Reaction.
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
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9. WARNINGS & PRECAUTIONS
Hypersensitivity
Appropriate medical treatment must be available
Altered Immunocompetence
Diminished immune response in immunocompromised persons
History of anthrax disease
Increased the potential for severe local adverse reactions
Limitation of vaccine effectiveness
BioThrax may not protect all recipients
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10. WARNINGS & PRECAUTIONS
Pregnancy (Category D)
BioThrax can cause fetal harm when administered to a pregnant woman.
Pregnant women should not be vaccinated against anthrax unless the potential
benefits of vaccination outweigh the potential risk to the fetus.
Observational study among 37,140 infants born to U.S. military service women who
received anthrax vaccine in pregnancy between 1998 and 2004 showed that birth
defects were slightly more common in first trimester-exposed infants.
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Ryan MA, Smith TC, Sevick CJ, Honner WK, Loach RA, Moore CA, Erickson JD. 2008. Birth defects among infants born to
women who received anthrax vaccine in pregnancy. Am J Epidemiol, 168:434-442.
13. Allergic reactions:
Anaphylaxis
Angioedema
Rash
Urticaria
Pruritus
Erythema multiforme
Anaphylactoid reaction
Stevens Johnson syndrome
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ADVERSE
REACTIONS
Post-marketing
experience
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to vaccine exposure.
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POSTMARKETING EXPERIENCE
14. Lymphadenopathy
Nausea
Paresthesia
Syncope, dizziness, tremor
Ulnar nerve neuropathy
Arthralgia, arthropathy, myalgia, rhabdomyolysis
Alopecia
Malaise, pain, flu-like symptoms
Cellulitis
Insomnia
Flushing
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ADVERSE
REACTIONS
Post-marketing
experience
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to vaccine exposure.
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POSTMARKETING EXPERIENCE
15. Infrequent reports of Multisystem disorders
defined as chronic symptoms involving:
fatigue,
mood-cognition,
and musculoskeletal system.
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ADVERSE
REACTIONS
Post-marketing
experience
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to vaccine exposure.
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POSTMARKETING EXPERIENCE
17. PREGNANCY & BREASTFEEDING
PREGNANCY
Pregnancy category D
Emergent’s vaccination pregnancy
registry
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BREASTFEEDING
No information on excretion in
breast milk, caution advised
18. MALE FERTILITY
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A retrospective study was performed at an in-vitro
fertilization clinic
BioThrax did not influence semen parameters (including
concentration, motility, and morphology), fertilization
rate, embryo quality or clinical pregnancy rates.
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19. OTHER POPULATIONS
The vaccine was not tested in children
The vaccine was not tested in the elderly (>65 years of age)
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20. VACCINE/DRUG INTERACTIONS
Co-administration with ciprofloxacin:
Does not alter pharmacokinetics of ciprofloxacin or the immunogenicity of BioThrax
Concomitant administration with other vaccines:
Concomitant administration with other vaccines not evaluated
Do not mix with other vaccines in one syringe/vial. Administer at different injection sites
ImmunosuppressiveTherapies:
No data regarding use with immunosuppressive therapies.
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21. COMPLETEDCLINICALTRIALS – PHASE I
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NCT # Title Interventions Population Enrollment Completion
NCT01263691
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax
Vaccine in Healthy Adults BioThrax|AV7909 |Control 18 to 50 (M, F) 105 Jun-12
NCT04148118
A Safety and Immunogenicity of Intranasal Nanoemulsion
Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults
BW-1010 |Saline (Placebo)
|BioThrax (positive control) 18 to 49 (M, F) 84 Sep-21
NCT00114621 Anthrax Vaccine Clinical Trials Anthrax Vaccine 18 to 45 (M, F) 93 May-11
NCT00057525
A New Anthrax Vaccine Administered by the Intramuscular (IM)
Route in Healthy Adults Anthrax|Alhdryogel or PBS 18 to 40 (M, F) 70 Aug-04
NCT01979406
A Phase 1 Ascending Dose Study to Assess the Safety and
Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines AVA|Ad4-PA-1|Ad4-PA-GPI-1 18 to 40 (M, F) 120 Sep-15
NCT02239172
PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA)
Anthrax Vaccine PA83-FhCMB 18 to 49 (M, F) 30 May-15
NCT01867957 Efficacy and Safety of Anthrax Vaccine, GC1109
Low-dose GC1109|High-dose
GC1109|Placebo 18 to 45 (M) 20 Dec-09
NCT00063843 Anthrax-rPA: Safety, Tolerability, Immunogenicity
Recombinant Protective Antigen,
Anthrax Vaccine Adsorbed
Child, Adult,
Older Adult 80 Aug-05
NCT02655549
A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult
Subjects Px563L, RPA563, or placebo 18 to 55 (M, F) 54 Jun-17
NCT00103467
Trial to Evaluate the Safety and Immunogenicity of an Anthrax
Recombinant Protective Antigen Vaccine rPA102 Vaccine 18 to 40 (M, F) 100
NCT04415749 NasoShield in Healthy Adults to Study Safety and Immunogenicity NasoShield|Other: Placebo 18 to 49 (M, F) 42 Mar-21
22. COMPLETEDCLINICALTRIALS – PHASE II
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NCT # Title Interventions Population Enrollment Completion
NCT03518125 BARDA Securing Anthrax Immunity For the Elderly BioThrax|AV7909|Placebo
18+ (Adult,
Older Adult) 305 Dec-19
NCT01770743
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine
Using 3 Schedules and Two Dose Levels AV7909|BioThrax 18 to 50 (M, F) 168 Dec-14
NCT01753115 Ciprofloxacin BioThrax Co-Administration Study BioThrax|Ciprofloxacin 18 to 45 (M, F) 154 Aug-13
NCT04067011 Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Ciprofloxacin |Doxycycline |
AV7909 18 to 45 (M, F) 210 Mar-20
NCT00170469
Safety, Tolerability and Immunogenicity of Recombinant Anthrax
Vaccine Compared With Anthrax Vaccine Adsorbed
AVA|rPA vaccine containing
alhydrogel 18 to 50 (M, F) 226 Feb-07
NCT00170456 Phase II Study of Range and Schedule of rPA Doses
rPA vaccine containing
alhydrogel 18 to 50 (M, F) 415 Feb-07
23. COMPLETED
CLINICAL
TRAILS
VELOCITY: An Anthrax Vaccine Clinical Study
AV7909 | BioThrax
Study design: Randomized, parallel assignment
Masking: Participant, Care Provider, Investigator,
Outcomes Assessor)
Participants: 3862 (18 – 65 years)
Date: 3/2019 – 8/2020
Completed, Results posted
Study Protocol
Statistical Analysis Plan
Informed Consent Form
NCT03877926
Phase III
NCT03877926
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24. COMPLETED
CLINICAL
TRAILS
Immunogenicity and Safety Study of a Three-
Dose BioThrax Regimen for Post-Exposure
Prophylaxis in Healthy Adults
BioThrax
Study design: Single group assignment,Open label
Participants: 200 (18 – 65 years)
Date: 11/2011 – 5/2012
Available documentation:
Study Results
NCT01491607
Phase III
NCT01491607
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25. COMPLETED
CLINICAL
TRAILS
Immunogenicity and Safety Study of a Three-
Dose BioThrax Regimen for Post-Exposure
Prophylaxis in Healthy Adults
BioThrax
Study design: Randomized, parallel assignment
Participants: 200 (18 – 65 years)
Date: 11/2011 – 5/2012
Available documentation:
Study Results
NCT01491607
Phase IV
NCT00119067
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27. COMPLETED
CLINICAL
TRAILS
Assessment of the Immunogenicity and Safety
of a Dose-Sparing BioThrax AVA Schedule
BioThrax
Study design: Randomized, parallel assignment
Masking:Open label
Participants: 328 (18 – 65 years)
Date: 7/2012 – 6/2013
Available documentation:
Study Results
NCT01641991
Phase IV
NCT01641991
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28. COMPLETED
CLINICAL
TRAILS
Effect of Raxibacumab on Immunogenicity of
Anthrax Vaccine Adsorbed
AVA | Raxibacumab | Diphenhydramine
Study design: Randomized, parallel assignment
Masking: Open label
Phase I
Participants: 573 (18 – 65 years)
Date: 2/2015 – 6/2017
Available documentation:
Study Results
Study Protocol
Statistical Analysis Plan
NCT02339155
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Phase IV
NCT02339155
29. OTHERCLINICALTRIALS
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NCT # Title Interventions Population Enrollment Completion
NCT00133484
Phase II
UMD rPA Regimen Trial in
Adults
Anthrax vaccine absorbed made from
Bacillus anthracis (AVA)
Recombinant protein antigen (rPA)
made from Bacillus anthracis
Recombinant protein antigen (rPA)
made from Escherichia coli 18 to 50 (M, F)
270
Terminated
No results
NCT03352466
Phase I
NasoShield Study of Safety
and Immunogenicity
NasoShield
BioThrax
Placebo
18 to 49 (M, F)
145
Unknown status
No results
30. ONGOINGCLINICALTRIALS
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NCT # Title Interventions Population Enrollment Completion
NCT04660201
Phase I Anthrax AV7909 Liquid vs
Lyophilized AV7909 18 to 45 (M, F) 40
Recruiting
No results available
NCT01624532
Phase II
A Study to Assess Dose-Response,
Efficacy (Immunogenicity) and the
Safety of GC1109 GC1109 or Placebo 19 to 65 (M, F) 345
Not yet recruiting
No results available
NCT00050310
n/a
Natural History of Anthrax: a Study
of Primary Infected, Recovered, and
Exposed Individuals (SPoRE); and
Evaluation of AVA-Vaccinated
Recipients
evaluate the natural history of
anthrax and immune response
to anthrax antigens over time
3 + (Child, Adult,
Older Adult), (M, F) 200
Recruiting
No results available
NCT02177721
Phase IV
Clinical Benefit, Safety and PK of
Raxibacumab in Subjects Exposed to
Bacillus Anthracis Collection of samples
Child, Adult, Older
Adult 100
Not yet recruiting
No results available
31. RECOMMENDED USE
The vaccine is not available to the general public
Recommended by CDC for adults with high-risk occupational exposure:
• Laboratory workers who work with anthrax
• People who handle infected animals or animal products (veterinarians)
• Certain U.S. military personnel
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