This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac™, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY®, GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2-10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95%CI 9708-12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95%CI 2368-3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1μg/ml, 95%CI 75.5-105.0) when compared to the PsACWY group (15.3μg/ml, 95%CI 12.3-19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2% in PsA-TT group vs 12.3% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac™ is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2-to-10-year-old Indian children.
Bibliographical noteFunding Information:
The authors gratefully acknowledge financial support from the Meningitis Vaccine Project ; the Serum Institute of India, Ltd. for vaccines, and technical support; DiagnoSearch for their help with pharmacovigilance, data management, and logistics; and the laboratories at CDC, Atlanta, GA, USA (Julie Chatt-Soroka and Jeffrey Martin), and the Health Protection Agency, Manchester, UK for ELISA and rSBA testing, respectively. The authors gratefully acknowledge the assistance of Nicole Basta who helped draft the initial manuscript. The study received support from the Health and Demographic Surveillance System, Vadu which is a member of the INDEPTH Network. Lastly, the authors express their gratitude to the children and their parents and the Vadu community as a whole for their support and participation in the study.
- Conjugate vaccine
- Serogroup A