التفاصيل البيبلوغرافية
| العنوان: |
Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. |
| المؤلفون: |
Bojang, Kalifa A, Milligan, Paul J M, Pinder, Margaret, Vigneron, Laurence, Alloueche, Ali, Kester, Kent E, Ballou, W Ripley, Conway, David J, Reece, William H H, Gothard, Philip, Yamuah, Lawrence, Delchambre, Martine, Voss, Gerald, Greenwood, Brian M, Hill, Adrian, McAdam, Keith P W J, Tornieporth, Nadia, Cohen, Joe D, Doherty, Tom |
| المصدر: |
Lancet. 12/8/2001, Vol. 358 Issue 9297, p1927. 8p. 1 Diagram, 4 Charts, 3 Graphs. |
| مصطلحات موضوعية: |
*ANTIMALARIALS, *PLASMODIUM falciparum, *VACCINES, *MEDICAL research, *DRUG efficacy |
| مصطلحات جغرافية: |
GAMBIA |
| مستخلص: |
Summary: Background: RTS,S/AS02 is a pre-erythrocytic malaria vaccine based on the circumsporozoite surface protein of Plasmodium falciparum fused to HBsAg, incorporating a new adjuvant (AS02). We did a randomised trial of the efficacy of RTS,S/AS02 against natural P falciparum infection in semi-immune adult men in The Gambia. Methods: 306 men aged 18-45 years were randomly assigned three doses of either RTS,S/AS02 or rabies vaccine (control). Volunteers were given sulfadoxine/pyrimethamine 2 weeks before dose 3, and kept under surveillance throughout the malaria transmission season. Blood smears were collected once a week and whenever a volunteer developed symptoms compatible with malaria. The primary endpoint was time to first infection with P falciparum. Analysis was per protocol. Findings: 250 men (131 in the RTS,S/AS02 group and 119 in the control group) received three doses of vaccine and were followed up for 15 weeks. RTS,S/AS02 was safe and well tolerated. P falciparum infections occurred significantly earlier in the control group than the RTS,S/AS02 group (Wilcoxon's test p=0.018). Vaccine efficacy, adjusted for confounders, was 34% (95% CI 8.0-53, p=0.014). Protection seemed to wane: estimated efficacy during the first 9 weeks of follow-up was 71% (46-85), but decreased to 0% (-52 to 34) in the last 6 weeks. Vaccination induced strong antibody responses to circumsporozoite protein and strong T-cell responses. Protection was not limited to the NF54 parasite genotype from which the vaccine was derived. 158 men received a fourth dose the next year and were followed up for 9 weeks; during this time, vaccine efficacy was 47% (4-71, p=0.037). Interpretation: RTS,S/AS02 is safe, immunogenic, and is the first pre-erythrocytic vaccine to show significant protection against natural P falciparum infection. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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