Emergence of a virulent new meningococcal W sequence type 11 in South America: experience, control measures and impact
http://www.meningitis.org/conference2015
Current epidemiology of meningococcal disease in the African meningitis belt and new WHO outbreak response guidelines after the Meningitis Vaccine Project
http://www.meningitis.org/conference2015
Emergence of a virulent new meningococcal W sequence type 11 in South America: experience, control measures and impact
http://www.meningitis.org/conference2015
Current epidemiology of meningococcal disease in the African meningitis belt and new WHO outbreak response guidelines after the Meningitis Vaccine Project
http://www.meningitis.org/conference2015
Dr Marie-Pierre Preziosi's presentation at Meningitis Research Foundation's 2013 conference, Meningitis & Septicaemia in Children & Adults http://www.meningitis.org/conference2013
Professor Michael Levin's presentation at Meningitis Research Foundation's 2013 conference Meningitis & Septicaemia in Children & Adults www.meningitis.org/conference2013
Novartis satellite breakfast session at the Meningitis Research Foundation 2013 conference, Meningitis & Septicaemia in Children & Adults presented by Emeritus Professor Richard Moxon, Dr Jamie Findlow and Dr Simon Nadel
Single-dose oral ciprofloxacin prophylaxis as a meningococcal meningitis outbreak response: results of a cluster-randomized trial
https://www.meningitis.org/mrf-conference-2017
Dr Marie-Pierre Preziosi's presentation at Meningitis Research Foundation's 2013 conference, Meningitis & Septicaemia in Children & Adults http://www.meningitis.org/conference2013
Professor Michael Levin's presentation at Meningitis Research Foundation's 2013 conference Meningitis & Septicaemia in Children & Adults www.meningitis.org/conference2013
Novartis satellite breakfast session at the Meningitis Research Foundation 2013 conference, Meningitis & Septicaemia in Children & Adults presented by Emeritus Professor Richard Moxon, Dr Jamie Findlow and Dr Simon Nadel
Single-dose oral ciprofloxacin prophylaxis as a meningococcal meningitis outbreak response: results of a cluster-randomized trial
https://www.meningitis.org/mrf-conference-2017
Meningococcal carriage in the African meningitis belt and the impact of MenAfriVac: an overview of the MenAfriCar project
http://www.meningitis.org/conference2015
For more information:
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VIRAL MENINGITIS
Viral meningitis is an infection usually affecting children under 5 years of age.
The virus causing the infection usually infects the meninges, which are the protective tissue coverings of the brain and spinal cord.
The meninges is made up of 3 distinct layers :
1. The Pia mater – which is the layer directly in contact with
the brain and spinal cord.
2. Arachnoid mater – which consists of spider web-like
extensions.
3. The Dura mater – which is the outermost and toughest
layer of the meninges.
Cerebrospinal fluid or CSF,which also protects the brain and spinal cord,flows between the meninges and the surface of the brain.
The most common causes of viral meningitis are :
1. The Mumps virus
2. The Measles virus
3. Enteroviruses
4. The Herpes virus
5. Japanese Encephalitis virus
The most common mechanism of transmission include :
1. Sneezing or Coughing
2. Faecal contamination
3. Bite from an infected insect (such as a mosquito)
After entering the body, the virus makes multiple copies of itself,and enters the bloodstream, eventually reaching the brain. Here, it crosses the blood brain barrier,to enter the CSF, ultimatley infecting the cells of the meninges.This causes an inflammation of the meninges,because of the body’s attempts to fight the infection.
Symptoms of viral meningitis in an infant or young child include :
1. Fever
2. Irritability
3. Loss of appetite
4. Decreased consciousness
Symptoms of viral meningitis in an older child or adult
include :
1. Fever
2. Headache
3. Neck stiffness
4. Photosensitivity
5. Decreased consciousness
6. Nausea or vomitting
In general,the symptoms of viral meningitis are less severe than what’s seen with bacterial meningitis.
Treatment for viral meningitis include :
1. Use of Acetaminophen/NSAIDs (for the fever & headache).
2. Acyclovir (if the meningitis is caused by the Herpes virus)
Besides supportive therapy, there is no specific
treatment for viral meningitis, which usually runs it
course within 2 weeks, if there are no complications.
This lecture describes the approach to screening, diagnosis and management of HIV and TB infection among pregnant patients. Prevention of Mother to Child Transmission of HIV infection mainly based on the Philippine Obstetrical and Gynecological Society Clinical Practice Recommendations.
A recent Presentation at National Annual Review Meeting of Core Group Polio Project (CGPP) -USAID funded project, ADRA India: implementing agency with technical support from CORE Secretariat
The PPT gives overview of PEI, global updates on PEI, Polio end game strategy and eradication timelines, polio legacy and link with Health Systems strengthening and relevant health programes etc. The PPT was presented at National Annual Review Meeting held for 2 days in Mussoorie for Core Group of Polio Project (CGPP) -a USAID funded polio eradication initiatives. ADRA India is one of the lead implementing agency for CGPP since 2004 and it has worked for nearly 15 years in polio across states in India.
Presentation from the 3rd Joint Meeting of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Networks, organised by the European Centre of Disease Prevention and Control - Stockholm, 11-13 February 2015
1Global Vaccination (attach this please with the previou.docxfelicidaddinwoodie
1
Global Vaccination (attach this please with the previous sections)
WHO estimates that three million cases of disease could be avoided annually with an appropriate prevention by vaccination.
Immunization System in Malasyia (more info please add to US)
Religious Views of Vaccination (Malaysia)(please attach this with the previous sections)
Grabenstein (2013) noted that polio immunization is obligatory when disease risk is high and the vaccine shown to have benefits far outweighing its risks.
National Immunization Program (NIP)
The Malaysian National Immunization Program (NIP) was introduced in the early 1950s and it has been given free to the children for their protection against major childhood diseases. The immunization program offers protection against major childhood diseases that can be prevented with vaccines including diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, measles, mumps, rubella, tuberculosis, polio and some diseases caused by the human papillomavirus. This program is available at all government clinics across the country.
Parents are responsible for ensuring that their children are protected from dangerous infectious diseases that can be prevented with a vaccine. Below is the national immunization schedule to ensure your child receives the vaccination at the right time (Malaysian MOH, 2017).
Vaccine Safety Surveillance
National Centre of Adverse Drug Reactions (ADR) Monitoring, National Pharmaceutical Control Bureau (NPCB) is responsible to monitor the safety of medicines and vaccines that are registered in Malaysia. NPCB is responsible for collecting all reporting adverse events related pharmaceutical products including vaccines. All reported adverse events will be documented and serious cases following vaccination will be investigated promptly to identify the cause of the adverse events. NPCB will make further investigation in terms of product quality and regulatory action will be taken based on the results of the investigation. Types of regulatory action that can be taken are the suspension of the product registration, product recall or cancellation of the product registration.
ADR reporting system has been introduced in Malaysia to enable health providers to participate in monitoring the safety of medicines and vaccines by reporting the adverse events. Ministry of Health Malaysia (MOH) has organized trainings to the health professionals on the importance of reporting of Adverse events following immunization (AEFIs) as described in the Guidelines for the Pharmacovigilance of Vaccines. Ongoing training will be conducted more actively to increase awareness among health care providers to report AEFI and importance of disseminating the information to parents/guardians.
Currently, the AEFI reporting system has been extended to the public whereby the parents/guardians of children who experience any adverse events can report to us by themselves (Malaysian MOH, 2017).
Immunization System in the US ...
OxfordSM's pharma case studies - providing a call to actionOxfordSM
Brand teams have to be increasingly innovative when finding ways to prompt patients and physicians to intervene at the right time.
Campaigns such as GSK’s Greatest Season Ever for FLONASE®, implemented last year in the United States which made the decision to prepare for the allergy season easier for patients by linking the proactive purchase of the brand to the start of the baseball season.
Providing A Call To Action:
We find that examples from within and outside of healthcare can often prompt this innovation. They act as a way of bringing in new perspectives and allowing teams to explore new avenues and new ideas.
So, in the spirit of hoping this will prompt some new ideas in your brand team, here are our favourite case studies that speak to the need to provide a call to action.
Similar to Marie Pierre @ MRF's Meningitis & Septicaemia in Children & Adults 2015 (20)
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Marie Pierre @ MRF's Meningitis & Septicaemia in Children & Adults 2015
1. The impact of MenAfriVac in the Meningitis Belt and
Prospects for Meningococcal Disease Prevention
through EPI and Higher Valent Vaccines
Dr Marie-Pierre Preziosi
Initiative for Vaccine Research, Department of Immunization, Vaccines and Biologicals
Meningitis and Septicaemia in Children and Adults 2015, Meningitis Research Foundation
Royal Society of Medicine, London, 4- 5 November 2015
2. 1
1996
Ministers of Health and Interior
from 16 African countries
recognized epidemic meningitis as a high priority
3. 2
• 1996 Epidemic
meningitis ,
high priority in
Africa
• 1999 Conjugate
meningococcal
vaccines
needed
• 2001 Project
Launch
• 2002 African
political will
for affordable
vaccines, and
Business model
defined
• 2003-04 Tech
transfer to SIIL
• 2005 Phase I trial
• 2006-2013
Comprehensive
vaccine
development in
India & Africa
• 2003-05
Enhanced disease
surveillance and
stockpile for
epidemic
response
• 2007-2008
Launch of carriage
studies
• June 2010 WHO
Prequalification
(1-29 year-olds)
following DCGI
licensure Jan. 2010
• 2010- 2014
Regulatory approval
at national level
• 2010 WHO/GACVS
Recommendation &
WHO/SAGE Policy
• 2014 Regulatory
approval, policy for
indication variation
• Sept. 2010 Phase1
introduction in 3
selected districts
• Dec. 2010
Nationwide
introduction in 3
countries
• 2010-2013
Enhanced
manufacturing
capacity (SIIL)
• 2016 Introduction
in routine
• 2010-2016 Mass
campaigns 1-29
year-olds in 26
countries in Africa
• 2011 Burkina Faso
initial measurement
of vaccine impact
• 2012 Chad
demonstration and
quantification of the
vaccine effect
• 2014 Impact
evaluation
framework defined
Research/
Design
Develop/
Validate
Approve/
Recommend
Introduce/
Optimize Scale-up/ Apply
An Integrated approach
Meningitis Vaccine Project (MVP) & partners 2001-2014
4. • Inducing strong herd protection
Large single dose mass vaccination
campaigns with high coverage, targeting
1–29 year-olds in 26 belt countries
• Protecting new birth cohorts
Routine EPI immunization or periodic
follow-up campaigns
• Enhancing surveillance and
outbreak response capacity
Throughout vaccine introduction + beyond
Rapid response to outbreaks (W, C, X and A
in the unprotected)
Adequate care/treatment of meningitis cases
Outbreak containment: emergency stockpile
MenAfriVac introduction strategy
7. MenAfriVac use in a controlled temperature chain (CTC)
• 2012: relabeled to allow for use in a CTC
– Pilot use in North Benin: successful implementation
• 2014: over 1.5 million persons vaccinated during
campaigns in 14 districts, 3 countries: Côte
d’Ivoire, Mauritania and Togo
– Wastage due to CTC (temperature or time): very low < 0.1%
– Reported vaccine coverage: very high > 95%
– Safety: no serious related AEFI
– Implementation: protocol well understood, good compliance
– HCW's Acceptance of the CTC approach : excellent
• GAVI financial support
• Implementation requires ad-hoc preparation,
training, supervision, monitoring and specific
indicators
8. Meningitis pathogen trends in the belt, 2006-2015
MenAfriVac introduction
Courtesy C. Lingani, WHO/AFRO IST-West
9. Vaccine effect on disease, on carriage &
transmission … THE evidence !
Lancet 2013
Emerging Infectious Diseases 2015
10. MenAfriVac campaigns,
A huge success
• Excellent coverage
– High population acceptance
– Reported coverage usually >95%
– Age group > 15 years often less well covered
– Mop-up campaigns conducted in areas with lower coverage
(Senegal, Cameroon)
• No new serious AEFI attributable to the vaccine
detected
• Vaccine wastage < 5%
• Operational costs 0.65 USD / target person usually
enough
12. Comparison of strategies A-D
http://www.who.int/immunization/sage/meetings/2014/october/presentations_background_docs/en/
Karachaliou A, Conlan AJK, Preziosi MP and TrotterC. Modelling long-term vaccination strategies with MenAfriVac® in the African meningitis belt. Clinical Infectious
Diseases 2015; 61(Suppl.5): S594-600.
If routine EPI is NOT TIMELY…
Epidemic likely in 2025 or before...
13. WHO updated recommendations
• Countries completing mass vaccination campaigns introduce
meningococcal A conjugate vaccine into the routine childhood
immunization programme within 1-5 years following campaign
• A one-time catch-up campaign should be conducted for birth
cohorts born since the initial mass vaccination and outside the
age range targeted by the routine immunization programme
WHO recommends that
SOURCE: Weekly epidemiological record, No.8, 20 February 2015, vol. 90, (pp. 57–68), available at http://www.who.int/wer/en/
14. WHO updated recommendations
A 1-dose schedule at 9-18 months of age based on local
programmatic and epidemiological considerations*
Any children who missed vaccination at the recommended age should be
vaccinated as soon as possible thereafter
For infants < 9 months of age, if compelling reasons exist,
a 2-priming dose infant schedule should be used starting at
3 months of age, with doses at least 8 weeks apart
WHO recommends
* Recommendation for RI based on the high level of herd immunity following mass campaigns, epidemiological evidence
on the age distribution of disease, and programmatic and economic considerations.
15. MenAfriVac 5 μg should be used for routine immunization of
infants and young children from 3 to 24 months of age
MenAfriVac (10 micrograms) should continue to be used
for catch-up and periodic campaigns from 12 months of age
onwards*
*Unless bridging studies have been conducted and show that MenAfriVac 5 μg can be used in older age groups
WHO recommends that
WHO updated recommendations
16. Totals Up to 2018
2015 SDF v12 0 0 5 14 7 26
2015 SDF v11 0 1 9 10 6 26
2010 SDF 9 2 8 4 2 25
Routine introduction date assumptions1,2
Niger
Nigeria
Mali
Sudan North
Ghana3
Burkina Faso
Chad
Cent. Afr. Rep.
Kenya
Tanzania
Cameroon
Guinea-Bissau
Mauritania
Benin
DR Congo
Ethiopia
Gambia
Senegal
Uganda
2015 2016 2017
1. Base scenario, Strategic Demand Forecast (SDF)
2. If a country chooses to administer the routine vaccine dose at 9 months of age: the catch-up campaign should be conducted if possible 3 months after the
routine introduction; if administered at 18 months of age: the catch-up campaign should be conducted if possible 7 months before the routine introduction
3. Ghana program is partially approved
<=2014 2018
Rwanda
Burundi
Cote d’Ivoire
Eritrea
Guinea
South Sudan
Togo
Introduced
Board Approved
Recommendation
Expected
Application received
Status of applications to Gavi
18. Multivalent meningococcal conjugate vaccines
• WHO prequalified vaccines
Menactra, Sanofi Pasteur
meningococcal ACWY conjugate vaccine - DT carrier, liquid
Menveo, GSK (ex Novartis)
meningococcal ACWY conjugate vaccine - CRM carrier, liquid-lyophilised
combined vaccine
• Licensed, not yet WHO PQ vaccines
Nimenrix, GSK
meningococcal ACWY conjugate vaccine - TT carrier, lyophilised vaccine
• In development
Sanofi Pasteur
meningococcal ACWY conjugate vaccine - TT carrier
Serum Institute of India
meningococcal ACWYX conjugate vaccine - TT and CRM carrier
19. Polyvalent meningococcal vaccine project
Courtesy Dr Mark Alderson, PATH
Funding UK Department for
International Development DFID, 2008
Partnership between PATH and SIIL
Goal Develop and license a
thermostable, affordable polyvalent
meningococcal conjugate vaccine for
sub-Saharan Africa, pentavalent ACWYX
A meningococcal vaccine that covers multiple strains has the potential
to eliminate meningococcal meningitis from the meningitis belt
PATH/Gabe Bienczycki
20. Early development issues
• Serum Instituted of India faced major IP issues since polyvalent
meningococcal conjugate vaccines are heavily “patented” with
extensive pharma “know how”
• No published guidelines for Group X meningococcal vaccines
• Srinivas Reddy Chilukuri, Peddi Reddy, Nikhil Avalaskar, Asha
Mallya, Sambhaji Pisal, Rajeev M. Dhere. Process development
and immunogenicity studies on a serogroup ‘X’ Meningococcal
polysaccharide conjugate vaccine. Biologicals 2014; 42: 160-8.
21. Product optimization
Fermentation/purification
• Yields of crude PS range from 600 mg/L for X to 900 mg/L for Y and W
• Purified PS yields 350 – 650 mg/L
Conjugation
• Conjugation yields between 20-35% with new conjugation technology
Formulation/configuration
• Lyophilization, with stabilizers
• Requirement for adjuvant to be assessed clinically
(aluminium phosphate, 125 µg Al3+)
• Detailed stability studies on Men A and Men C
23. Target Product Profile
Active (Lyophilized)
Composition/Dose Men/Poly
Men A -TT 5 μg
Men C-CRM 5 μg
Men Y-CRM 5 μg
Men W-CRM 5 μg
Men X -TT 5 μg
Presentation Lyophilized, 1 & 5 Dose
Stabilizer < 5%
Diluent / Dose
Alum (Al+++) 125 μg / Dose (0.5 ml)
Vehicle Sodium chloride in WFI
Preservative No
Men X Ps-TT Conjugate properties confirmed at NIBSC
Remaining conjugates under testing at NIBSC, UK & University of Cape Town, SA
24. Summary
A, C, Y, W and now X polysaccharides comply to WHO specifications
The lyophilized Men A-TT and Men C-CRM conjugates showed
excellent stability even when stored at 40ºC for six months
Three formulations and a licensed comparator were tested rabbits.
The SBA results consistently showed that the lead candidate
vaccine was equivalent or better than the comparator for groups A,
C, Y and W. The Men X Ps -TT conjugate generated high SBA titers.
Lead formulation was tested with/without aluminum phosphate
(AI3+, 125 µg/dose); IgG and SBA titers were higher with alum
One and five dose presentations are proposed for the pentavalent
without preservative. All conjugates vaccine components are at
5μg with/without 125 μg of alum per human dose
25. SIIL MCV-5 Clinical/Regulatory Plans
Clinical development will be predominantly in Africa
The vaccine will be initially licensed for export in India
Target is WHO Prequalification
Phase 1/2 single dose in adults and 2 doses in toddlers ±alum
Menactra as comparator vaccine. Target start date: Jan, 2016
Phase 2/3 infants 2 doses, 9 months and 15-18 months of age
Menactra as comparator vaccine
Phase 2/3 2-55 years of age in India and Africa in parallel
Menveo as comparator vaccine
Immunoassays at PHE Manchester (Ray Borrow)
The Niger epidemic and so many others confirm the important work of advancing the development of a polyvalent meningococcal vaccine that covers a spectrum of serogroups in addition to A (including C, W, Y, and X).
Phase 1 clinical trial of polyvalent conjugate vaccine to start in early 2016.
CRM is recombinant made using the Pfenex expression system.