Immunogenicity of Fractional Doses of Tetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccine: Results from a Randomized Non-Inferiority Controlled Trial in Uganda

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dc.contributor.authorGuerin, Philippe J.
dc.contributor.authorNæss, Lisbeth M.
dc.contributor.authorFogg, Carole
dc.contributor.authorRosenqvist, Einar
dc.contributor.authorPinoges, Loretxu
dc.contributor.authorBajunirwe, Francis
dc.contributor.authorNabasumba, Carolyn
dc.contributor.authorBorrow, Ray
dc.contributor.authorFrøholm, Leif O.
dc.contributor.authorGhabri, Salah
dc.contributor.authorBatwala, Vincent
dc.contributor.authorTwesigye, Rogers
dc.contributor.authorAaberge, Ingeborg S.
dc.contributor.authorRøttinge, John-Arne
dc.contributor.authorPiola, Patrice
dc.contributor.authorCaugan, Dominique A.
dc.date.accessioned2021-12-15T09:16:19Z
dc.date.available2021-12-15T09:16:19Z
dc.date.issued2008
dc.description.abstractNeisseria 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. 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 favorable, as observed in other studies. 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.en_US
dc.description.sponsorshipThe study was co-financed by The Norwegian Institute of Public Health, GlobInf (University of Oslo, Norway), and Médecins Sans Frontières. Aventis Pasteur donated the vaccines used in the trial. The funders had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscripten_US
dc.identifier.citationGuerin, P. J., Næss, L. M., Fogg, C., Rosenqvist, E., Pinoges, L., Bajunirwe, F., ... & Caugant, D. A. (2008). 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, 2(12), e342. DOI: doi:10.1371/journal.pntd.0000342en_US
dc.identifier.uridoi:10.1371/journal.pntd.0000342
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/555
dc.language.isoenen_US
dc.publisherPLoS neglected tropical diseasesen_US
dc.relation.ispartofseriesPLoS neglected tropical diseases;2(12)
dc.subjectRandomized Non-Inferiority Controlled Trialen_US
dc.subjectImmunogenicity of Fractional Dosesen_US
dc.subjectTetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccineen_US
dc.titleImmunogenicity of Fractional Doses of Tetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccine: Results from a Randomized Non-Inferiority Controlled Trial in Ugandaen_US
dc.typeArticleen_US
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