Elimination of meningitis A epidemics in Africa MenAfriVac future plans Meningitis & Septicaemia in Children and Adults 2013 , ninth conference Meningitis Research Foundation, Royal Society of Medicine, London 5 th November 2013 Marie-Pierre Preziosi
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Elimination of meningitis A epidemics in Africa; MenAfriVac future plans
Dr Marie-Pierre Preziosi's presentation at Meningitis Research Foundation's 2013 conference, Meningitis & Septicaemia in Children & Adults http://www.meningitis.org/conference2013
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Elimination of meningitis A epidemics in Africa MenAfriVac future plansMeningitis & Septicaemia in Children and Adults 2013, ninth conference Meningitis Research Foundation, Royal Society of Medicine, London 5th November 2013
Marie-Pierre Preziosi
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An exemplary partnership with the critical role of a developing country vaccine manufacturer
• State-of-the-art development of an affordable vaccine designed to address an unmet major public health need in Africa
• Diligent registration on this new vaccine
• A 0-year period from vaccine licensure to introduction at public-health scale
• Development of a strong international scientific network
The Meningitis Vaccine Project (MVP)A successful vaccine development for Africa
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Epidemic meningitis in Africa: 1948-2012
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Epidemic meningitis: impact on families
More than 10 percent of patients die, typically within 24-48 hours of the onset of symptoms
25% of survivors have long-term aftereffects
Expenditures of 3 to 4 months of disposable income
Source: WHO, Colombini A, Batiano F, Zongo, S, et al. Costs for households and community perception of meningitis epidemics in Burkina Faso. Clinical Infectious Diseases 2009;49:1520–1525.
PATH/Monique Berlier
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Epidemic meningitis: impact on public health
Marked seasonality with periodic devastating epidemics
Overwhelms health infrastructures and disrupts routine programs
Greater than 80% serogroup A
WHO/Kader Konde
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The Meningitis Vaccine Project (MVP)Early development
June 2001: Bill & Melinda Gates Foundation funds MVP• Partnership between WHO and PATH • Goal of eliminating epidemic meningitis as a public health problem
in sub-Saharan Africa through the development, testing, licensure, and widespread use of conjugate meningococcal vaccines
2001–2002: Project constraints, African public health officials emphasize the key importance of a low vaccine price for a sustainable supply
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MenA vaccine development
core team
Tetanus toxoidprocess development
manufacturing
Men A polysaccharide
Conjugationmethod
Target price US$ <0.50/dose
Group A polysaccharide produced by SynCo BioPartners, Amsterdam. Technology then transferred to SIIL
Conjugation method developed at CBER/ FDA, Bethesda, USA; transferred and scaled-up at SIIL
Serum Institute of India (SIIL) process development and manufacturing
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• PsA-TT Ps = menA polysaccharide conjugated to a protein carrier TT = tetanus Toxoid
Vaccine development according to international standards
Source: Lee CH, Kuo WC, Beri S, et al. Preparation and characterization of an immunogenic meningococcal group A conjugate vaccine for use in Africa. Vaccine 2009;27:726-32.
The Meningitis Vaccine Project (MVP)Preparation and characterization of a meningococcal conjugate vaccine
999
Vaccine Clinical developmentGCP Regulatory Inspections of trial sites
1010* For all studies, reference was a PsACWY Vaccine (Mencevax®), except for study PsA-TT-001 and PsA-TT-005, where the reference vaccine was a PsAC vaccine
(Menomune® and MenA+C®, respectively)
Group A rSBA Geometric Mean Titers (GMT) with 95%CI Pre-vaccination and 28 days after immunization in 5 clinical trials
Licence for new indicationPolicyForecastingCountry planning Country advocacySustainable fiscal space in countries…
Completing roll-out
December 2016
Risk assessment in remaining countries ForecastingProcurementFunding, GAVI ApplicationsPlanningEvaluating…
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MenAfriVac (PsA-TT) Pediatric VariationObjectives
Rationale• To provide a sustainable strategy to maintain population immunity
in African meningitis belt countries following the initial mass vaccination campaigns with MenAfriVac among 1 to 29 year-olds, by routine immunization of new birth cohorts
Questions of interest • Immunization schedules (age, number of doses)• Vaccine dosage• Concomitant administrations
2020
Vaccinations
at age 14-18 weeks
at age 9 months
at age 12-18 months
Immune response and persistence in infants
Group A Serum Bactericidal Antibody Titres (rSBA) GMT (95%CI) from 14 weeks to 36 months of age, Ghana
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Immune persistence in older age groups
0%
10%
20%
30%
40%
50%
60%
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100%
0.1 1 10 100 1000
Perc
enta
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Group A specific IgG Geometric Mean Concentrations (logarithmic scale)
Reverse cumulative distribution curves in Group A specific IgG Geometric Mean Concentrations for PsA-TT-003 subjects by vaccine at 4 years after a single immunization (1d, n=181 ; 3d, n=86)
Persistence - 1d - PsA-TT at 2-10 years - Four years after
Persistence - 3d - PsACWY at 2-10 years - Four years after
Men A rSBA Geometric Mean Titers (logarithmic scale)
Reverse cumulative distribution curves in Men A rSBA Geometric Mean Titers for PsA-TT-003 subjects by vaccine after a single immunization (1d, n=181 ; 3d, n=86)
Persistence - 1d - PsA-TT at 2-10 years - Four years after
Persistence - 3d - PsACWY at 2-10 years - Four years after
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Determination of the following components • Optimal routine schedules ?
One or two EPI doses Supplemental periodic campaigns for low coverage districts
• Target population for routine ? national or subnational
• Target population for an initial catch-up campaign ? For cohorts missed since the mass campaign
Development of routine introduction plans that will • Promote overall enhancement of routine vaccination activities • Consider routine introduction of other new vaccines
Key considerations for the next future
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AARSH
Recherche en Santé Humaine
In collaboration with health authorities of 26 countries in sub-Saharan Africa and of India