Elimination of meningitis A epidemics in Africa; MenAfriVac future plans

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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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  • Key points:Meningitis belt of Africa –extends from Senegal to Ethiopia with the red countries considered hyper-endemic. (Ethiopia, Chad, Niger, Northern Nigeria, Burkina Faso, Mali) considered hyper-endemicCyclical disease with large periodic outbreaksBackground info:1905: first documented epidemic, Northern Nigeria 1919-1924: second cycle with over 45,000 deaths in Northern Nigeria1935-1937: third cycle: Nigeria 6456 deaths1951-60: 340,000 cases with 53,000 deaths1996-1997: 300,000 cases with 30,000 deaths2010: 30,103Map source: http://upload.wikimedia.org/wikipedia/commons/9/96/Meningitis-Epedemics-World-Map.png
  • Photo: Distraught young man looking after his comatose brother in Boussé’s rural health center, Burkina FasoBackground info:A detailed socioeconomic study during the 2007 epidemic in Burkina Faso showed that each case of meningitis in a family results in a sudden expenditure of about US$90—what amounts to three or four months of the family's disposable income. Families with few resources cycle inexorably downward to the next level of poverty. In addition, about 25 percent of survivors have long-term aftereffects such as deafness leaving them less likely to be economically productive citizens, and they often become wards of an already financially stretched extended family. Source: Clin Infect Dis. 2009 Nov 15;49(10):1520-5.Costs for households and community perception of meningitis epidemics in burkina faso.Colombini A, Bationo F, Zongo S, Ouattara F, Badolo O, Jaillard P, Seini E, Gessner BD, Da Silva A.Agence de Médecine Préventive, Ferney-Voltaire, France. acolombini@aamp.org
  • Healthcare providers have to halt critical programs, such as child immunization, to attend to the sick80% of the meningitis is caused by Men A, which is not prevalent in developed countriesMarket forces failed to produce a lasting solution since endemic in poor countries
  • Some of the nearly 11,000 health care workers mobilized for the “catch up” vaccination. 2,710 vaccination teams of four staff each were deployed in the 274,200-sq-km country to immunize 11,075,996 Burkinabè, starting with schoolchildren, in only 10 days.
  • Some of the 3,000 attendees at the Burkina Faso launch event. School children were prioritized first for immunization.
  • Elimination of meningitis A epidemics in Africa; MenAfriVac future plans

    1. 1. 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 5th November 2013 Marie-Pierre Preziosi
    2. 2. The Meningitis Vaccine Project (MVP) A successful vaccine development for Africa  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 2 2
    3. 3. Epidemic meningitis in Africa: 1948-2012 3 3
    4. 4. 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 PATH/Monique Berlier 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. 4 4
    5. 5. 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 5 5
    6. 6. 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 6 6
    7. 7. MenA vaccine development Group A polysaccharide produced by SynCo BioPartners, Amsterdam. Technology then transferred to SIIL Men A polysaccharide Serum Institute of core team India (SIIL) process development and Tetanus toxoid process development manufacturing manufacturing Conjugation method developed at CBER/ FDA, Bethesda, USA ; transferred and scaled-up at SIIL Conjugation method Target price US$ <0.50/dose 7 7
    8. 8. The Meningitis Vaccine Project (MVP) Preparation and characterization of a meningococcal conjugate vaccine • PsA-TT  Ps = menA polysaccharide conjugated to a protein carrier  TT = tetanus Toxoid 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.  Vaccine development according to international standards 8 8 8
    9. 9. Vaccine Clinical development GCP Regulatory Inspections of trial sites 9 9 9
    10. 10. Immune response in 1-29 year-olds PsA Vaccine* PsA-TT Vaccine Pre Post Group A rSBA Geometric Mean Titers (GMT) with 95%CI Pre-vaccination and 28 days after immunization in 5 clinical trials Pre Post 100 000 10 000 1 000 100 10 1 V1 V1 V3 V3 V1 V1 V3 V3 V1 V1 V3 V3 V1 V1 V3 V3 V1 V1 V3 V3 V1 V1 V3 V3 V1 V1 V1 V1 V3 V3 V3 V3 PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA-PsACWY PsA- PsAC PsA- PsAC PsA- PsA- PsA- PsAC PsA- PsA- PsA- PsAC TT TT TT TT TT TT TT TT TT TT TT TT TT TT TT TT TT TT Lot A Lot B Lot C Lot A Lot B Lot C 12-23 months 2-10 years 2-10 years 11-17 years 18-29 years 18-35 years 5-10 years PsA-TT-002 PsA-TT-003a PsA-TT-003 PsA-TT-003 PsA-TT-003 PsA-TT-001 PsA-TT-005 10 * 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) 10
    11. 11. Scientific & Community Meetings after each clinical trial sites, health authorities, partners participating communities 11 11 11
    12. 12. Licensure and prequalification  MenAfriVac® licensed by Drugs Controller General of India in December 2009  WHO prequalification awarded in June 2010 SIIL/S. Vinayak 12 12
    13. 13. MenAfriVac introduction Strategy • Inducing strong herd immunity  • Protecting new birth cohorts  • single dose mass vaccinations in 1–29 year-olds, with high coverage in 26 meningitis belt countries periodic follow-up campaigns or routine EPI immunization Enhancing surveillance and epidemic response  throughout vaccine introduction and beyond 13 13
    14. 14. PATH/ Gabe Bienczycki Official launch day – health workers 14 14
    15. 15. PATH/ Gabe Bienczycki Official launch day – school children 15 15
    16. 16. MenAfriVac rollout 2010–2016 as of 5th November 2013 16 16
    17. 17. 100 000 000th vaccination WHO/Bachir Cotonou, Benin, 15 November 2012 17 17 17
    18. 18. Sustainable Men disease elimination: next steps setting the scene post 2014 when the MVP project formally ends Setting impact evaluation framework Launching routine EPI December 2014 October 2015 Completing roll-out Surveillance Specific surveys (sero, carriage, …) Vaccine efficacy Policy evaluation Epidemics containment Next generation multivalent vaccines … Licence for new indication Policy Forecasting Country planning Country advocacy Sustainable fiscal space in countries … December 2016 Risk assessment in remaining countries Forecasting Procurement Funding, GAVI Applications Planning Evaluating … 18 18
    19. 19. MenAfriVac (PsA-TT) Pediatric Variation Objectives  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 19 19
    20. 20. Immune response and persistence in infants Vaccinations at age 14-18 weeks at age 9 months at age 12-18 months Group A Serum Bactericidal Antibody Titres (rSBA) GMT (95%CI) from 14 weeks to 36 months of age, Ghana 20 20
    21. 21. Immune persistence in older age groups Reverse cumulative distribution curves in Group A specific IgG Geometric Mean Concentrations for PsATT-003 subjects by vaccine at 4 years after a single immunization (1d, n=181 ; 3d, n=86) 100% 90% 80% 60% 50% 40% 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) 30% 100% 20% 90% 10% 80% 1000 0% 0.1 1 10 100 Group A specific IgG Geometric Mean Concentrations (logarithmic scale) Persistence - 1d - PsA-TT at 2-10 years - Four years after Persistence - 3d - PsACWY at 2-10 years - Four years after 70% Percentage of subjects Percentage of subjects 70% 60% 50% 40% 30% 20% 10% 0% 2 4 8 16 32 64 128 256 512 1024 2048 4096 8192 16384 32768 65536 131072 Men A rSBA Geometric Mean Titers (logarithmic scale) Persistence - 1d - PsA-TT at 2-10 years - Four years after Persistence - 3d - PsACWY at 2-10 years - Four years after 21 21
    22. 22. Key considerations for the next future  Determination of the following components • Optimal routine schedules ?   • Target population for routine ?  • national or subnational Target population for an initial catch-up campaign ?   One or two EPI doses Supplemental periodic campaigns for low coverage districts 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 22 22
    23. 23. AARSH Recherche en Santé Humaine In collaboration with health authorities of 26 countries in sub-Saharan Africa and of India23 23
    24. 24. 24 24

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