Impact of Quadrivalent Conjugate (MenACWY-CRM) and Serogroup B (4CMenB) Meningococcal Vaccines on Meningococcal Carriage in English University Students
The document discusses issues related to meningococcal B (MenB) vaccines before and after implementation. It addresses questions such as whether vaccine components are immunogenic, if vaccines can be incorporated into routine schedules, vaccine tolerability, and how to assess effectiveness. Studies show MenB vaccines have immunogenic components and can be given according to routine schedules with minimal interference or reduction in immune response. The vaccines demonstrate a good safety profile in clinical trials with few serious adverse events potentially related to vaccination. Overall, the document evaluates key considerations for MenB vaccines prior to and following widespread use.
The document discusses the Global Meningitis Genome Partnership (GMGP), which aims to address inequities in genomic surveillance capacity for meningitis pathogens between high-income and low-income countries. It outlines what has been achieved so far, including establishing standardized metadata for sequencing and epidemiological data. The GMGP is working to incorporate genome surveillance into regional surveillance strategies, initially focusing on Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus agalactiae in Africa. Open data sharing is encouraged according to clear governance policies. Standardizing metadata and curating sequencing data in a central library are discussed to facilitate consistent analysis and data visualization for public health benefit
- There was a significant reduction in cases of invasive bacterial infections like pneumococcal disease, H. influenzae, and meningococcal disease in 2020 coinciding with COVID-19 containment measures across many countries. Vaccination coverage rates have decreased dramatically in Brazil representing a potential risk of rebound in infectious disease rates. Maintaining disease surveillance is important to inform authorities on current disease burden and carriage rates even though some diseases were reduced during the pandemic.
This document discusses optimal schedules for controlling pneumococcal infection in countries with high and low carriage. It notes that the African Meningitis Belt has seen sub-optimal pneumococcal conjugate vaccine (PCV) coverage due to geopolitical factors and vulnerable populations. Outbreaks in Ghana pre- and post-PCV introduction show that herd protection may be inadequate. Research is needed to better understand pneumococcal biology and prevention. Improving PCV access and coverage, including schedules with boosters and catch-up campaigns targeting 5-29 year olds, may help prevent outbreaks. Strengthening surveillance systems allows rapid response.
Professor Muhamed-Kheir TAHA MD, PhD, HDR presented on lessons and impacts for meningitis in the COVID-19 era. Data showed cumulative cases of invasive meningococcal disease (IMD) from 2014-2020 in France as well as distribution of IMD cases from 2011-2020. Vaccine use in France declined during the COVID-19 pandemic in 2020, with reduced doses of the 5-month and 12-month vaccines. Distribution of IMD cases by age group from 2011-2021 showed an immunity gap in childhood due to the pandemic. Conclusions were that reduced pathogen circulation may decrease herd immunity, social distancing was associated with lower vaccine uptake, and countries need plans to promote
The document discusses issues related to meningococcal B (MenB) vaccines before and after implementation. It addresses questions such as whether vaccine components are immunogenic, if vaccines can be incorporated into routine schedules, vaccine tolerability, and how to assess effectiveness. Studies show MenB vaccines have immunogenic components and can be given according to routine schedules with minimal interference or reduction in immune response. The vaccines demonstrate a good safety profile in clinical trials with few serious adverse events potentially related to vaccination. Overall, the document evaluates key considerations for MenB vaccines prior to and following widespread use.
The document discusses the Global Meningitis Genome Partnership (GMGP), which aims to address inequities in genomic surveillance capacity for meningitis pathogens between high-income and low-income countries. It outlines what has been achieved so far, including establishing standardized metadata for sequencing and epidemiological data. The GMGP is working to incorporate genome surveillance into regional surveillance strategies, initially focusing on Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus agalactiae in Africa. Open data sharing is encouraged according to clear governance policies. Standardizing metadata and curating sequencing data in a central library are discussed to facilitate consistent analysis and data visualization for public health benefit
- There was a significant reduction in cases of invasive bacterial infections like pneumococcal disease, H. influenzae, and meningococcal disease in 2020 coinciding with COVID-19 containment measures across many countries. Vaccination coverage rates have decreased dramatically in Brazil representing a potential risk of rebound in infectious disease rates. Maintaining disease surveillance is important to inform authorities on current disease burden and carriage rates even though some diseases were reduced during the pandemic.
This document discusses optimal schedules for controlling pneumococcal infection in countries with high and low carriage. It notes that the African Meningitis Belt has seen sub-optimal pneumococcal conjugate vaccine (PCV) coverage due to geopolitical factors and vulnerable populations. Outbreaks in Ghana pre- and post-PCV introduction show that herd protection may be inadequate. Research is needed to better understand pneumococcal biology and prevention. Improving PCV access and coverage, including schedules with boosters and catch-up campaigns targeting 5-29 year olds, may help prevent outbreaks. Strengthening surveillance systems allows rapid response.
Professor Muhamed-Kheir TAHA MD, PhD, HDR presented on lessons and impacts for meningitis in the COVID-19 era. Data showed cumulative cases of invasive meningococcal disease (IMD) from 2014-2020 in France as well as distribution of IMD cases from 2011-2020. Vaccine use in France declined during the COVID-19 pandemic in 2020, with reduced doses of the 5-month and 12-month vaccines. Distribution of IMD cases by age group from 2011-2021 showed an immunity gap in childhood due to the pandemic. Conclusions were that reduced pathogen circulation may decrease herd immunity, social distancing was associated with lower vaccine uptake, and countries need plans to promote
Progress is being made on developing a combined MenABCWY vaccine. Studies are underway evaluating the immunogenicity and safety of combining different meningococcal vaccines that target serogroups A, C, W, Y. Combining the vaccines could simplify immunization schedules, reduce costs by needing fewer doses, and increase vaccination uptake by reducing the number of required injections. However, a combined vaccine may also increase reactogenicity and interfere with the immune response to other concomitant vaccines. Ongoing studies are evaluating different potential MenABCWY vaccine combinations to determine the optimal formulation.
This document discusses pneumococcal genomics, vaccines, and antibiotic resistance. It examines how pneumococcal carriage and disease changes following vaccination as non-vaccine serotypes increase. The author analyzed carriage samples from Native American communities before and after vaccination, finding 35 sequence clusters but vaccination did not change overall carriage prevalence. The document explores how the accessory genome varies between locations and how negative frequency dependent selection structures pneumococcal populations. Models are developed to predict which sequence clusters may increase or decrease following vaccination based on accessory genome content and frequency dependent fitness. Comparisons are made between predicted and actual changes in sequence cluster prevalence post-vaccination.
Cryptococcal meningitis is responsible for 15% of AIDS-related deaths globally. A strategic framework is needed to end cryptococcal meningitis deaths by 2030 by addressing gaps in screening, diagnosis, and access to critical antifungal medicines. Key targets include expanding access to CD4 and cryptococcal antigen tests, improving availability of lumbar puncture and antifungal drugs, and increasing research to develop better diagnostics and treatments.
This document summarizes changes in invasive meningococcal disease (IMD) cases in Germany during the COVID-19 pandemic. It finds that overall IMD cases decreased during the first pandemic period (PP) in 2020 compared to pre-pandemic levels, with the largest declines in children ages 1-4 and 5-9. However, IMD cases increased again after restrictions eased. The decrease in IMD cases during increased restrictions correlates with decreased mobility based on Google mobility indices.
1) The PSERENADE project analyzed surveillance data from over 50 sites in 34 countries to assess the impact of PCV10 and PCV13 introduction on pneumococcal meningitis incidence globally in children under 5 years old and adults 18 years and older.
2) For both age groups, PCV10 and PCV13 significantly reduced meningitis caused by serotypes covered by the vaccines, with almost elimination in children under 5 years old within 5 years. Herd protection was observed in adults as well.
3) PCV13 significantly reduced meningitis from additional serotypes it covers compared to PCV10, though serotype 19A increased with PCV10 and serotype 3 trends were unclear
This study examined sequelae in 49 pediatric patients with invasive meningococcal disease (IMD) in Chile between 2009-2019. The researchers found that 59% of patients experienced sequelae at hospital discharge, with neurological disorders being the most common at 59.2%. Risk factors for sequelae included age under 1 year old, shock, and meningeal signs at admission. Sequelae were also associated with a clinical diagnosis of meningitis with meningococcemia. The study concludes that multidisciplinary follow-up is needed to reduce the long-term impacts of IMD in children.
National Center for Immunization & Respiratory Diseases
Rapid Diagnostic Tests for Bacterial Meningitis Pathogens: where we are now and what’s next.
Xin Wang Chief, Bacterial Meningitis Laboratory Director WHO Collaborating Center for Meningitis MVPDB/DBD/NCIRD/CDC Meningitis Research Foundation Conference Nov 1-3, 2021
The document discusses the current state of rapid diagnostic tests for bacterial meningitis pathogens and outlines a vision for their future development and deployment. It describes existing tests and their limitations. Potential new platforms are identified that could meet targets outlined in a target product profile. Advanced technologies like sequencing and CRISPR/Cas are also discussed
Gonorrhea is a sexually transmitted infection caused by the bacterium Neisseria gonorrhoeae that can lead to serious health complications if left untreated. There is an urgent need for a gonorrhea vaccine due to increasing antibiotic resistance and the potential for the disease to become untreatable. However, vaccine development faces several difficulties as N. gonorrhoeae is highly variable, able to avoid the immune system, and past vaccine trials have shown no efficacy. Continued research is focused on identifying conserved antigens that could induce a protective immune response through vaccination.
Dr. Sami Gottlieb of the World Health Organization discussed the potential for meningococcal B (MenB) vaccines to help prevent gonococcal infection on a global scale. MenB vaccines have shown preliminary efficacy against gonorrhea in clinical trials and epidemiological data. WHO is working to define priority populations for gonorrhea vaccines and assess how existing MenB programs could be leveraged. Effectiveness may depend on disease epidemiology, vaccine characteristics, target populations, and integration with current immunization systems. Ongoing trials of MenB vaccines against gonorrhea will provide critical data to inform introduction decisions.
Gavi has supported the rollout of the Meningococcal A Conjugate Vaccine (MenAfrivac) in 26 African countries since 2010 through routine immunization and preventive campaigns for those aged 1-29. No cases of meningococcal A have been identified in the African meningitis belt since 2018. In 2018, non-A outbreaks prompted Gavi to authorize support for multivalent meningococcal conjugate vaccines contingent on regulatory approval, review processes, and cost targets being met. The estimated cost per death averted for the risk-based multivalent meningococcal conjugate vaccine program would be $6,300 to $13,400.
While pneumococcal disease primarily burdens infants in their first year of life, relying on herd effects from PCV schedules could help protect others indirectly and reduce costs. However, caution is needed, as indirect protection depends on direct protection of main transmitters, and key questions remain around who transmits, the duration of protection from boosters, and lessons from cRCTs comparing 2-dose and 3-dose schedules in Malawi and Gambia. Programmatic concerns like booster dose coverage, incomplete dosing, travel/border effects, and lack of surveillance also warrant consideration.
The document discusses Nepal's introduction of the PCV 10 vaccine using a 2+1 schedule of administration at 6 weeks, 10 weeks, and 9 months. A trial found this schedule to be equally effective as a 3+0 schedule. Surveillance data showed declines in invasive pneumococcal disease cases and pneumonia with consolidation following vaccine introduction. Pneumococcal carriage among children with clinical pneumonia under 2 years old declined significantly, but no decrease was seen in older children. Short term impact was observed using the 2+1 schedule, but continued surveillance is needed to assess long term vaccine impact.
The document discusses optimal vaccination schedules for pneumococcal disease in countries with high and low disease carriage. It summarizes studies comparing 1+1 and 2+1 vaccination schedules for PCV10 and PCV13 vaccines. The studies found immunogenicity was equivalent or higher for many serotypes with 1+1 schedules. The UK switched to a 1+1 schedule in 2020 and ongoing surveillance will monitor its impact on invasive pneumococcal disease cases. Future studies will evaluate the impact of the schedule change and potential for disease rebound over time.
This document discusses considerations for determining which age groups should be targeted for mass meningococcal vaccination campaigns. It notes that conjugate vaccines provide both direct and indirect (herd) protection if the age groups driving transmission are included. Models can simulate different options, like changes to UK MenC schedules or long-term strategies for MenAfriVac. Good age-specific data is needed on disease risk and carriage prevalence to identify peak transmitters. Campaigns targeting ages 1-29 years or compressing to 1-14 years are options, but more modeling is required to evaluate different approaches. Geographic risk must also be considered when expanding meningococcal programs.
The document discusses models used to assess the impact of COVID-19 on meningitis infections. Specifically, it adapted existing meningococcal vaccine models to investigate the effect of lower vaccine uptake and social distancing measures on meningitis infection dynamics in (1) countries in the African meningitis belt where the MenAfriVac vaccine is used and (2) the UK in relation to the MenACWY teenage vaccination program. The modeling of MenACWY in the UK found that a 75-60% reduction in social mixing due to COVID-19 social distancing would substantially reduce meningococcal carriage and disease, outweighing the impact of a 34% reduction in MenACWY vaccine uptake from 2020-
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Progress is being made on developing a combined MenABCWY vaccine. Studies are underway evaluating the immunogenicity and safety of combining different meningococcal vaccines that target serogroups A, C, W, Y. Combining the vaccines could simplify immunization schedules, reduce costs by needing fewer doses, and increase vaccination uptake by reducing the number of required injections. However, a combined vaccine may also increase reactogenicity and interfere with the immune response to other concomitant vaccines. Ongoing studies are evaluating different potential MenABCWY vaccine combinations to determine the optimal formulation.
This document discusses pneumococcal genomics, vaccines, and antibiotic resistance. It examines how pneumococcal carriage and disease changes following vaccination as non-vaccine serotypes increase. The author analyzed carriage samples from Native American communities before and after vaccination, finding 35 sequence clusters but vaccination did not change overall carriage prevalence. The document explores how the accessory genome varies between locations and how negative frequency dependent selection structures pneumococcal populations. Models are developed to predict which sequence clusters may increase or decrease following vaccination based on accessory genome content and frequency dependent fitness. Comparisons are made between predicted and actual changes in sequence cluster prevalence post-vaccination.
Cryptococcal meningitis is responsible for 15% of AIDS-related deaths globally. A strategic framework is needed to end cryptococcal meningitis deaths by 2030 by addressing gaps in screening, diagnosis, and access to critical antifungal medicines. Key targets include expanding access to CD4 and cryptococcal antigen tests, improving availability of lumbar puncture and antifungal drugs, and increasing research to develop better diagnostics and treatments.
This document summarizes changes in invasive meningococcal disease (IMD) cases in Germany during the COVID-19 pandemic. It finds that overall IMD cases decreased during the first pandemic period (PP) in 2020 compared to pre-pandemic levels, with the largest declines in children ages 1-4 and 5-9. However, IMD cases increased again after restrictions eased. The decrease in IMD cases during increased restrictions correlates with decreased mobility based on Google mobility indices.
1) The PSERENADE project analyzed surveillance data from over 50 sites in 34 countries to assess the impact of PCV10 and PCV13 introduction on pneumococcal meningitis incidence globally in children under 5 years old and adults 18 years and older.
2) For both age groups, PCV10 and PCV13 significantly reduced meningitis caused by serotypes covered by the vaccines, with almost elimination in children under 5 years old within 5 years. Herd protection was observed in adults as well.
3) PCV13 significantly reduced meningitis from additional serotypes it covers compared to PCV10, though serotype 19A increased with PCV10 and serotype 3 trends were unclear
This study examined sequelae in 49 pediatric patients with invasive meningococcal disease (IMD) in Chile between 2009-2019. The researchers found that 59% of patients experienced sequelae at hospital discharge, with neurological disorders being the most common at 59.2%. Risk factors for sequelae included age under 1 year old, shock, and meningeal signs at admission. Sequelae were also associated with a clinical diagnosis of meningitis with meningococcemia. The study concludes that multidisciplinary follow-up is needed to reduce the long-term impacts of IMD in children.
National Center for Immunization & Respiratory Diseases
Rapid Diagnostic Tests for Bacterial Meningitis Pathogens: where we are now and what’s next.
Xin Wang Chief, Bacterial Meningitis Laboratory Director WHO Collaborating Center for Meningitis MVPDB/DBD/NCIRD/CDC Meningitis Research Foundation Conference Nov 1-3, 2021
The document discusses the current state of rapid diagnostic tests for bacterial meningitis pathogens and outlines a vision for their future development and deployment. It describes existing tests and their limitations. Potential new platforms are identified that could meet targets outlined in a target product profile. Advanced technologies like sequencing and CRISPR/Cas are also discussed
Gonorrhea is a sexually transmitted infection caused by the bacterium Neisseria gonorrhoeae that can lead to serious health complications if left untreated. There is an urgent need for a gonorrhea vaccine due to increasing antibiotic resistance and the potential for the disease to become untreatable. However, vaccine development faces several difficulties as N. gonorrhoeae is highly variable, able to avoid the immune system, and past vaccine trials have shown no efficacy. Continued research is focused on identifying conserved antigens that could induce a protective immune response through vaccination.
Dr. Sami Gottlieb of the World Health Organization discussed the potential for meningococcal B (MenB) vaccines to help prevent gonococcal infection on a global scale. MenB vaccines have shown preliminary efficacy against gonorrhea in clinical trials and epidemiological data. WHO is working to define priority populations for gonorrhea vaccines and assess how existing MenB programs could be leveraged. Effectiveness may depend on disease epidemiology, vaccine characteristics, target populations, and integration with current immunization systems. Ongoing trials of MenB vaccines against gonorrhea will provide critical data to inform introduction decisions.
Gavi has supported the rollout of the Meningococcal A Conjugate Vaccine (MenAfrivac) in 26 African countries since 2010 through routine immunization and preventive campaigns for those aged 1-29. No cases of meningococcal A have been identified in the African meningitis belt since 2018. In 2018, non-A outbreaks prompted Gavi to authorize support for multivalent meningococcal conjugate vaccines contingent on regulatory approval, review processes, and cost targets being met. The estimated cost per death averted for the risk-based multivalent meningococcal conjugate vaccine program would be $6,300 to $13,400.
While pneumococcal disease primarily burdens infants in their first year of life, relying on herd effects from PCV schedules could help protect others indirectly and reduce costs. However, caution is needed, as indirect protection depends on direct protection of main transmitters, and key questions remain around who transmits, the duration of protection from boosters, and lessons from cRCTs comparing 2-dose and 3-dose schedules in Malawi and Gambia. Programmatic concerns like booster dose coverage, incomplete dosing, travel/border effects, and lack of surveillance also warrant consideration.
The document discusses Nepal's introduction of the PCV 10 vaccine using a 2+1 schedule of administration at 6 weeks, 10 weeks, and 9 months. A trial found this schedule to be equally effective as a 3+0 schedule. Surveillance data showed declines in invasive pneumococcal disease cases and pneumonia with consolidation following vaccine introduction. Pneumococcal carriage among children with clinical pneumonia under 2 years old declined significantly, but no decrease was seen in older children. Short term impact was observed using the 2+1 schedule, but continued surveillance is needed to assess long term vaccine impact.
The document discusses optimal vaccination schedules for pneumococcal disease in countries with high and low disease carriage. It summarizes studies comparing 1+1 and 2+1 vaccination schedules for PCV10 and PCV13 vaccines. The studies found immunogenicity was equivalent or higher for many serotypes with 1+1 schedules. The UK switched to a 1+1 schedule in 2020 and ongoing surveillance will monitor its impact on invasive pneumococcal disease cases. Future studies will evaluate the impact of the schedule change and potential for disease rebound over time.
This document discusses considerations for determining which age groups should be targeted for mass meningococcal vaccination campaigns. It notes that conjugate vaccines provide both direct and indirect (herd) protection if the age groups driving transmission are included. Models can simulate different options, like changes to UK MenC schedules or long-term strategies for MenAfriVac. Good age-specific data is needed on disease risk and carriage prevalence to identify peak transmitters. Campaigns targeting ages 1-29 years or compressing to 1-14 years are options, but more modeling is required to evaluate different approaches. Geographic risk must also be considered when expanding meningococcal programs.
The document discusses models used to assess the impact of COVID-19 on meningitis infections. Specifically, it adapted existing meningococcal vaccine models to investigate the effect of lower vaccine uptake and social distancing measures on meningitis infection dynamics in (1) countries in the African meningitis belt where the MenAfriVac vaccine is used and (2) the UK in relation to the MenACWY teenage vaccination program. The modeling of MenACWY in the UK found that a 75-60% reduction in social mixing due to COVID-19 social distancing would substantially reduce meningococcal carriage and disease, outweighing the impact of a 34% reduction in MenACWY vaccine uptake from 2020-
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Mercurius is named after the roman god mercurius, the god of trade and science. The planet mercurius is named after the same god. Mercurius is sometimes called hydrargyrum, means ‘watery silver’. Its shine and colour are very similar to silver, but mercury is a fluid at room temperatures. The name quick silver is a translation of hydrargyrum, where the word quick describes its tendency to scatter away in all directions.
The droplets have a tendency to conglomerate to one big mass, but on being shaken they fall apart into countless little droplets again. It is used to ignite explosives, like mercury fulminate, the explosive character is one of its general themes.
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
Impact of Quadrivalent Conjugate (MenACWY-CRM) and Serogroup B (4CMenB) Meningococcal Vaccines on Meningococcal Carriage in English University Students
1. Impact of a Quadrivalent Conjugate
(MenACWY-CRM) or a Serogroup B (4CMenB)
Meningococcal Vaccine on Meningococcal
Carriage in English University Students
Robert C. Read and Colleagues
2. Study Methods
Pre-licensure study to assess effect on carriage at an individual level
• Phase III, multi-centre, RCT
• 2,968 students from universities at 10 different
UK sites
• 3 month enrolment (Sep–Dec 2010)
• Subjects received either:
– 2 doses of 4CMenB (BEXSERO)
– 1 dose of MenACWY-CRM (MENVEO)/1 dose of saline
placebo
– 2 doses of Japanese encephalitis (IXIARO)
(control)
• Nasopharyngeal swabs taken
at baseline, and at Months
1, 2, 4, 6 and 12
• Carriage isolate characterisation performed
at HPA (PHE) and Oxford University
3. Primary Analysis at 1 Month After the Vaccination Series
4CMenB co-primary
Carriage prevalence of virulent sequence types (ST)* of N. meningitidis capsular group B at 1 month following
administration of 2 doses of 4CMenB
Vaccine Groups
4CMenB
Number
87
75
-18.2%
%
9.50%
8.08%
N
Visit 3
[Month 2]
Control
Efficacy %
(95% CI)
916
928
(-73.3 – 19.4)
*Virulent ST types are those capsular group B ST types (or clonal complex members) causing disease in the UK (2006-2010).
MenACWY-CRM co-primary
Carriage prevalence of N. meningitidis combined serogroups A, C, W and Y at 1 month following administration of a
single dose of MenACWY-CRM
Vaccine Groups
MenACWY-CRM
Number
56
58
16.0%
%
5.87%
6.12%
N
Visit 2
[Month 1]
Control
Efficacy %
(95% CI)
954
947
Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as
identified within the multivariate model.
(-27.3 – 44.5)
4. MenACWY-CRM – Carriage at Cumulative Later
Sampling Points
MenACWY-CRM secondary
Carriage prevalence and calculated efficacy of combined serogroups CWY and serogroup Y across cumulative
later timepoints (Visits 3–6)
Vaccine Groups
MenACWYCRM
Number
C, W, Y
Serogroupable
Control
193
260
%
5.5%
36.2%
7.4%
(15.6 – 51.7)
N
Serogroupable
3520
3504
Number
Y
Efficacy %
(95% CI)
157
227
%
4.5%
39.0%
6.5%
(17.3 – 55.0)
N
3520
3504
MenACWY-CRM reduces nasopharyngeal carriage
of N. meningitidis serogroup CWY strains
Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as
identified within the multivariate model.
5. 4CMenB– Carriage at Cumulative Later Sampling Points
4CMenB secondary
Carriage prevalence and calculated efficacy for carriage of combined capsular groups BCWY or all N. meningitidis strains
across cumulative later timepoints (Visits 4–6)
Vaccine Groups
4CMenB
Number
539
26.6%
%
18.0%
20.9%
2489
2576
(10.5 – 39.9)
Number
797
885
18.2%
%
32.0%
34.4%
N
Any N.
meningitidis
449
N
B, C, W, Y
Capsular group
Control
Efficacy %
(95% CI)
2489
2576
(3.4 – 30.8)
4CMenB reduces nasopharyngeal carriage of
N. meningitidis capsular group BCWY strains
Non-significant trends for virulent B strains (12.6%; p=0.350) and all ST B strains (15.6%;
p=0.225)
Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as
identified within the multivariate model.
6. 4CMenB – Exploratory Analysis
Risk Factor Groups With High Transmission/Acquisition
4CMenB secondary
Carriage prevalence and calculated efficacy for carriage of combined capsular groups BCWY or all N. meningitidis strains
across cumulative later timepoints (Visits 4–6)
B, C, W, Y
Capsular group
Efficacy %
(95% CI)
Early Enrollers
(<30 Days After Start of the Semester)
N=1022 – 1031
Smokers
N=320 – 425
Any N. meningitidis
Efficacy %
(95% CI)
32.0%
33.7%
(8.2 – 49.6)
(13.9 – 49.0)
44.8%
32.2%
(14.0 – 64.5)
(2.5 – 52.9)
• In all risk factor groups, although trends were evident for efficacy against
virulent B strains and all ST B strains, statistical significance was not met.
Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as
identified within the multivariate model.
7. Conclusions
• Primary objectives were not achieved for either MenACWY-CRM or 4CMenB
• MenACWY-CRM: Secondary analyses demonstrated an impact on carriage of CWY
combined
• 4CMenB: Secondary analyses demonstrated an impact on carriage of BCWY combined
and any N. meningitidis
– Effect apparently enhanced among groups at high risk for transmission
– Trends observed in carriage impact and new acquisition of MenB strains
• Overall results support a possible herd impact by both vaccines
• Only post-implementation surveys within large scale vaccination programs will
determine fully the population level impact of these vaccines
8. Acknowledgements
• Clinical Research Facility staff at Sheffield, Liverpool,
Manchester, Middlesbrough, Oxford, Southampton, Bristol, St
George’s, Guildford, Nottingham
• UK National Institute of Health Clinical Research Network
(NIHR CRN)
• Public Health England
• Novartis Vaccines and Diagnostics
David Baxter
Rohit Bazaz
Ray Borrow
David R. Chadwick
Peter M. Dull
Saul N. Faust
Adam Finn
Tav Ganguli
Stefanie Gilchrist
Stephen Gordon
Steve J. Gray
Tom Havelock
T. Heath
Claudia Kittel
J.M. Lewis
Maggie McCarthy
Begonia Morales-Aza
Keith R. Neal
Ifeanyichukwu Okike
Kamlesh Patel
Andrew J. Pollard
Robert Read
Matthew D. Snape
David P.J. Turner
John Williams
10