A phase I safety and immunogenicity trial with the candidate malaria vaccine RTS,S/SBAS2 in semi-immune adults in The Gambia.

J F Doherty Medical Research Council Laboratories, Banjul, The Gambia.

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M Pinder Medical Research Council Laboratories, Banjul, The Gambia.

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N Tornieporth Medical Research Council Laboratories, Banjul, The Gambia.

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C Carton Medical Research Council Laboratories, Banjul, The Gambia.

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L Vigneron Medical Research Council Laboratories, Banjul, The Gambia.

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P Milligan Medical Research Council Laboratories, Banjul, The Gambia.

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W R Ballou Medical Research Council Laboratories, Banjul, The Gambia.

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C A Holland Medical Research Council Laboratories, Banjul, The Gambia.

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K E Kester Medical Research Council Laboratories, Banjul, The Gambia.

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G Voss Medical Research Council Laboratories, Banjul, The Gambia.

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P Momin Medical Research Council Laboratories, Banjul, The Gambia.

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B M Greenwood Medical Research Council Laboratories, Banjul, The Gambia.

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K P McAdam Medical Research Council Laboratories, Banjul, The Gambia.

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J Cohen Medical Research Council Laboratories, Banjul, The Gambia.

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DOI:
https://doi.org/10.4269/ajtmh.1999.61.865
Volume/Issue:
Volume 61: Issue 6
Page(s):
865–868
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RTS,S is a novel pre-erythrocytic malaria vaccine based on the circumsporozoite surface protein (CSP) of Plasmodium falciparum linked to hepatitis B surface antigen (HBs) and combined with a novel adjuvant system (SBAS2). We have conducted a Phase I trial with three doses of this vaccine given at 0, 1, and 6 months to 20 semi-immune, adult, male volunteers in The Gambia to assess its safety and immunogenicity. Eighteen of the 20 volunteers completed the study. There were no clinically significant local or systemic adverse events following each vaccination. Hematologic and biochemical indices before and two weeks after each vaccination showed no evidence of toxicity. Antibody titers to both CSP and HBs showed a significant increase after vaccination; these were the largest after the third dose. We conclude that the RTS,S/SBAS2 vaccine induces no significant toxicity in this semi-immune population and produces significant increases in antibody titers to CSP.

Published Online:
Dec 1999
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
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