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dc.contributor.authorFrançois Nostenen_US
dc.contributor.authorChristine Luxemburgeren_US
dc.contributor.authorDennis E. Kyleen_US
dc.contributor.authorW. Ripley Ballouen_US
dc.contributor.authorJanet Wittesen_US
dc.contributor.authorEh Wahen_US
dc.contributor.authorTan Chongsuphajaisiddhien_US
dc.contributor.authorDaniel M. Gordonen_US
dc.contributor.authorNicholas J. Whiteen_US
dc.contributor.authorJerald C. Sadoffen_US
dc.contributor.authorD. Gray Heppneren_US
dc.contributor.otherShoklo Malaria Research Uniten_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherArmed Forces Research Institute of Medical Sciences, Thailanden_US
dc.contributor.otherWalter Reed Army Institute of Researchen_US
dc.contributor.otherStatistics Collaborativeen_US
dc.contributor.otherJohn Radcliffe Hospitalen_US
dc.identifier.citationLancet. Vol.348, No.9029 (1996), 701-707en_US
dc.description.abstractBackground. Previous efficacy trials of SPf66 malaria vaccine have produced conflicting results in different populations. We report a randomised double-blind trial of the SPf66 vaccine conducted in Karen children aged 2-15 living in a malarious region of northwestern Thailand. Recombinant hepatitis B vaccine was used as a comparator. Methods. The study had a power of 90% to detect an efficacy of 30%, defined as a reduction in the incidence of first cases of symptomatic falciparum malaria after three doses of vaccine. 1221 children received three immunisations and were eligible for the primary efficacy analysis. Intense active and passive case detection continued over 15 months of follow-up. Findings. The SPf66 vaccine was well tolerated, although 26 children had mild or moderately severe local or systemic allergic reactions, compared with none in the comparator group. The vaccine was immunogenic; after three doses, 73% of recipients had seroconverted. There were no deaths due to malaria during the study. During the 15-month period of evaluation there were 379 first cases of symptomatic falciparum malaria (195 in the SPf66 recipients, 184 in the comparator group); an SPf66 efficacy of -9% (95% CI -33 to 14, p = 0.41). No significant differences between the two study groups in parasite density or any other measure of malaria-related morbidity were detected. Interpretation. These findings are consistent with a recent study showing lack of efficacy of SPf66 among Gambian infants and differ from earlier positive reports from South America and evidence of borderline efficacy from Tanzania. We conclude that SPf66 does not protect against clinical falciparum malaria and that further efficacy trials are not warranted.en_US
dc.rightsMahidol Universityen_US
dc.titleRandomised double-blind placebo-controlled trial of SPf66 malaria vaccine in children in northwestern Thailanden_US
Appears in Collections:Scopus 1991-2000

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