Development of a Group A meningococcal conjugate vaccine for sub-saharan Africa: clinical trial results
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1 Development of a Group A meningococcal conjugate vaccine for sub-saharan Africa: clinical trial results Global Immunization Meeting 2009, United Nations HQ New York City, February 2009
2 MenA conjugate vaccine - MenAfriVac Sample 2
3 Ongoing Scheduled Safety Lot to Lot Consistency Phase III Mali 2-29 year-olds May09-Jun10 Phase III India 5-10 yr-olds Apr09- Jan 10 Dose Selection Infant Indication Schedule Evaluation Infant Indication Phase II Ghana Infants Nov08-Aug12 Safety Immunogenicity Memory Immune Persistence Safety Immunogenicity Immune Persistence Carriage Phase II Mali - The Gambia month-olds Sep06-Aug09 Phase II/III India 2-10 year-olds Aug07-Apr09 Phase II/III Senegal, Mali, The Gambia 2-29 yr-olds Aug07-Apr09 Safety Immunogenicity Immune Persistence Phase I India year-olds Aug05-Dec06 Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun Jan Jun
4 4
5 Phase II Study Design in African Toddlers Primary Response First dose Group 1 PsA-TT conjugate vaccine (study vaccine group) Group 2 ACWY polysaccharide vaccine (reference vaccine group) Group 3 Hib vaccine (control vaccine group) PsA-TT-002 Africa 2 study sites: Mali & The Gambia 601 Toddlers months of age (randomization 1:1) 5
6 Pivotal Phase II in Africans (12-23 months of age) Immune Response at Week 4 - Men A rsba Titres Reverse Cumulative Distribution Curves PsA-TT Vaccine PsACWY Vaccine Hib-TT Vaccine 96% (190/198) 4-fold responders in PsA-TT vaccine group vs. 64 % (123/193) in PsACWY vaccine group (reference) = p (PsACWY) p (PsA-TT ) = -32% [ -40%; -25% ] 6
7 PsA-TT002 study design Ps booster First dose Group 1 PsA-TT conjugate vaccine Group 2 ACWY polysaccharide vaccine Booster dose Group 1b: 1/5th ACWY polysaccharide vaccine Group 2b: 1/5th ACWY polysaccharide vaccine Group 3 Hib vaccine Group 3b: 1/5th ACWY polysaccharide vaccine 7
8 Pivotal Phase II in Africans (12-23 months of age) Immune Memory at Week 40 - Men A rsba GMTs in children boosted with 1/5 th PsACWY after one dose of PsA-TT or PsACWY or Hib-TT PsA-TT primed toddlers immune memory at age months 1 month after 1/5 th of PsACWY Pre-booster Post-booster (1 mth) 10 1 PsA-TT PsACWY Hib-TT 8
9 MVP Phase II/III in African children & adults 2-29 yrs of age -- Week 4 Men A rsba titres Reverse cumulative distribution curves PsA-TT Ab response at age 2-29 years 1 month after a single dose 78% (471/602) 4-fold responders in PsA-TT vaccine group vs. 46% (134/290) in PsACWY vaccine group (reference) = p (PsACWY) p (PsA-TT ) = -32% [ -39%; -25% ] 9
10 Conclusions from clinical trials Promising results from clinical trials of MenAfriVac, the Men A Conjugate Vaccine (PsA-TT), developed by MVP and Serum Institute the PsA-TT vaccine was safe and highly immunogenic when administered as a single dose in children 1 to 3 years of age a single dose of PsA-TT in the second year of life primes for immunological memory and induces bactericidal antibodies that persist results from trials in older age groups (2 to 29 year-olds) show good safety and high immunogenicity in India and Africa 10
11 Expected public health outcomes of MenA conjugate vaccine introduction strategy Eliminate Men A epidemics and establish herd immunity and broad community protection Over 10 years this strategy will prevent Over one million cases of meningitis Over 100,000 deaths About 250,000 cases of disability Free up public health resources currently used annually to combat meningitis epidemics Remove financial drain on families and communities from epidemics and sequelae 11
12 The Meningitis Vaccine Project 12
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