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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Immunogenicity and safety of a meningococcal a conjugate vaccine in Africans
New England Journal of Medicine, Volume 364, No. 24, Year 2011
Notification
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Description
Background: Group A meningococci are the source of major epidemics of meningitis in Africa. An affordable, highly immunogenic meningococcal A conjugate vaccine is needed. Methods: We conducted two studies in Africa to evaluate a new MenA conjugate vaccine (PsA-TT). In study A, 601 children, 12 to 23 months of age, were randomly assigned to receive PsA-TT, a quadrivalent polysaccharide reference vaccine (PsACWY), or a control vaccine (Haemophilus influenzae type b conjugate vaccine [Hib-TT]). Ten months later, these children underwent another round of randomization within each group to receive a full dose of PsA-TT, a one-fifth dose of PsACWY, or a full dose of Hib-TT, with 589 of the original participants receiving a booster dose. In study B, 900 subjects between 2 and 29 years of age were randomly assigned to receive PsA-TT or PsACWY. Safety and reactogenicity were evaluated, and immunogenicity was assessed by measuring the activity of group A serum bactericidal antibody (SBA) with rabbit complement and performing an IgG group A - specific enzyme-linked immunosorbent assay. Results: In study A, 96.0% of the subjects in the PsA-TT group and 63.7% of those in the PsACWY group had SBA titers that were at least four times as high as those at baseline; in study B, 78.2% of the subjects in the PsA-TT group and 46.2% of those in the PsACWY group had SBA titers that were at least four times as high as those at baseline. The geometric mean SBA titers in the PsA-TT groups in studies A and B were greater by factors of 16 and 3, respectively, than they were in the PsACWY groups (P<0.001). In study A, the PsA-TT group had higher antibody titers at week 40 than the PsACWY group and had obvious immunologic memory after receiving a polysaccharide booster vaccine. Safety profiles were similar across vaccine groups, although PsA-TT recipients were more likely than PsACWY recipients to have tenderness and induration at the vaccination site. Adverse events were consistent with age-specific morbidity in the study areas; no serious vaccine-related adverse events were reported. Conclusions: The PsA-TT vaccine elicited a stronger response to group A antibody than the PsACWY vaccine. (Funded by the Meningitis Vaccine Project through a grant from the Bill and Melinda Gates Foundation; Controlled-Trials.com numbers, ISRCTN78147026 and ISRCTN87739946.) Copyright © 2011 Massachusetts Medical Society.
Authors & Co-Authors
Sow, Samba Ousmane
Mali, Bamako
Centre Pour le Développement Des Vaccins
Okoko, Brown Jacob
Gambia, Banjul
Medical Research Council Laboratories Gambia
Diallo, Aldiouma M.
Senegal, Dakar
Institut de Recherche Pour le Développement Dakar
Viviani, Simonetta
France, Ferney-voltaire
Meningitis Vaccine Project
Borrow, Ray
United Kingdom, London
Public Health England
Carlone, George M.
United States, Atlanta
Centers for Disease Control and Prevention
Tapia, Milagritos D.
Mali, Bamako
Centre Pour le Développement Des Vaccins
Akinsola, Adebayo Kolawole
Gambia, Banjul
Medical Research Council Laboratories Gambia
Arduin, Pascal
Senegal, Dakar
Institut de Recherche Pour le Développement Dakar
Findlow, Helen
United Kingdom, London
Public Health England
Elie, Cheryl M.
United States, Atlanta
Centers for Disease Control and Prevention
Haidara, Fadima Cheick
Mali, Bamako
Centre Pour le Développement Des Vaccins
Adegbola, Richard A.
Gambia, Banjul
Medical Research Council Laboratories Gambia
Diop, Doudou
Senegal, Dakar
Institut de Recherche Pour le Développement Dakar
Parulekar, Varsha
India, Mumbai
Diagnosearch Life Sciences
Chaumont, Julie
France, Ferney-voltaire
Meningitis Vaccine Project
Martellet, Lionel
France, Ferney-voltaire
Meningitis Vaccine Project
Diallo, Fatoumata Binta Tidiane
Mali, Bamako
Centre Pour le Développement Des Vaccins
Idoko, Olubukola T.
Gambia, Banjul
Medical Research Council Laboratories Gambia
Tang, Yuxiao
France, Ferney-voltaire
Meningitis Vaccine Project
Plikaytis, Brian D.
United States, Atlanta
Centers for Disease Control and Prevention
Kulkarni, Prasad Suryakant
India, Pune
Serum Institute of India
Marchetti, Elisa
France, Ferney-voltaire
Meningitis Vaccine Project
LaForce, F. Marc
France, Ferney-voltaire
Meningitis Vaccine Project
Préziosi, Marie Pierre
Switzerland, Geneva
Organisation Mondiale de la Santé
Statistics
Citations: 170
Authors: 25
Affiliations: 9
Identifiers
Doi:
10.1056/NEJMoa1003812
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Maternal And Child Health
Study Design
Randomised Control Trial