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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Immunogenicity of fractional doses of tetravalent A/C/Y/W135 meningococcal polysaccharide vaccine: Results from a randomized non-inferiority controlled trial in Uganda
PLoS Neglected Tropical Diseases, Volume 2, No. 12, Article e342, Year 2008
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Description
Background: Neisseria meningitidis serogroup A is the main causative pathogen of meningitis epidemics in sub-Saharan Africa. In recent years, serogroup W135 has also been the cause of epidemics. Mass vaccination campaigns with polysaccharide vaccines are key elements in controlling these epidemics. Facing global vaccine shortage, we explored the use of fractional doses of a licensed A/C/Y/W135 polysaccharide meningococcal vaccine. Methods and Findings: We conducted a randomized, non-inferiority trial in 750 healthy volunteers 2-19 years old in Mbarara, Uganda, to compare the immune response of the full dose of the vaccine versus fractional doses (1/5 or 1/10). Safety and tolerability data were collected for all subjects during the 4 weeks following the injection. Pre- and post-vaccination sera were analyzed by measuring serum bactericidal activity (SBA) with baby rabbit complement. A responder was defined as a subject with a ≥4-fold increase in SBA against a target strain from each serogroup and SBA titer ≥ 128. For serogroup W135, 94% and 97% of the vaccinees in the 1/5- and 1/10-dose arms, respectively, were responders, versus 94% in the full-dose arm; for serogroup A, 92% and 88% were responders, respectively, versus 95%. Non-inferiority was demonstrated between the full dose and both fractional doses in SBA seroresponse against serogroups W135 and Y, in total population analysis. Non-inferiority was shown between the full and 1/5 doses for serogroup A in the population non-immune prior to vaccination. Non-inferiority was not shown for any of the fractionate doses for serogroup C. Safety and tolerability data were favourable, as observed in other studies. Conclusions: While the advent of conjugate A vaccine is anticipated to largely contribute to control serogroup A outbreaks in Africa, the scale-up of its production will not cover the entire "Meningitis Belt" target population for at least the next 3 to 5 years. In view of the current shortage of meningococcal vaccines for Africa, the use of 1/5 fractional doses should be considered as an alternative in mass vaccination campaigns. © 2008 Guerin et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2584372/bin/pntd.0000342.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2584372/bin/pntd.0000342.s002.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC2584372/bin/pntd.0000342.s003.doc
Authors & Co-Authors
Guérin, Philippe Jean Jean
France, Paris
Epicentre
Norway, Oslo
Folkehelseinstituttet
Norway, Oslo
Universitetet I Oslo
Næss, Lisbeth Meyer
Norway, Oslo
Folkehelseinstituttet
Norway, Oslo
Universitetet I Oslo
Fogg, Carole
France, Paris
Epicentre
Rosenqvist, Einar
Norway, Oslo
Folkehelseinstituttet
Norway, Oslo
Universitetet I Oslo
Pinoges, Loretxu L.P.
France, Paris
Epicentre
Bajunirwe, Francis
France, Paris
Epicentre
Uganda, Mbarara
Mbarara University of Science and Technology
Nabasumba, Carolyn
France, Paris
Epicentre
Borrow, Ray
United Kingdom, London
Public Health England
Frøholm, L. Oddvar
Norway, Oslo
Folkehelseinstituttet
Ghabri, Salah
France, Paris
Epicentre
Bátwala, Vincent K.
France, Paris
Epicentre
Uganda, Mbarara
Mbarara University of Science and Technology
Twesigye, Rogers
France, Paris
Epicentre
Aaberge, Ingeborg Sundsvalen
Norway, Oslo
Folkehelseinstituttet
Norway, Oslo
Universitetet I Oslo
Røttingen, John-Ame
Norway, Oslo
Folkehelseinstituttet
Norway, Oslo
Universitetet I Oslo
Norway, Oslo
Norwegian Knowledge Centre for Health Services
Piola, Patrice
France, Paris
Epicentre
Caugant, Dominique A.
Norway, Oslo
Folkehelseinstituttet
Norway, Oslo
Universitetet I Oslo
Statistics
Citations: 22
Authors: 16
Affiliations: 6
Identifiers
Doi:
10.1371/journal.pntd.0000342
Research Areas
Maternal And Child Health
Study Design
Cross Sectional Study
Study Locations
Uganda