title: A phase I safety and immunogenicity trial with the candidate malaria vaccine RTS,S/SBAS2 in semi-immune adults in The Gambia.
abstract: 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.
authors.affiliation: Medical Research Council Laboratories, Banjul, The Gambia.
authors.forename: J F
authors.initials: JF
authors.lastname: Doherty
authors.forename: M
authors.initials: M
authors.lastname: Pinder
authors.forename: N
authors.initials: N
authors.lastname: Tornieporth
authors.forename: C
authors.initials: C
authors.lastname: Carton
authors.forename: L
authors.initials: L
authors.lastname: Vigneron
authors.forename: P
authors.initials: P
authors.lastname: Milligan
authors.forename: W R
authors.initials: WR
authors.lastname: Ballou
authors.forename: C A
authors.initials: CA
authors.lastname: Holland
authors.forename: K E
authors.initials: KE
authors.lastname: Kester
authors.forename: G
authors.initials: G
authors.lastname: Voss
authors.forename: P
authors.initials: P
authors.lastname: Momin
authors.forename: B M
authors.initials: BM
authors.lastname: Greenwood
authors.forename: K P
authors.initials: KP
authors.lastname: McAdam
authors.forename: J
authors.initials: J
authors.lastname: Cohen
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood; D000953:Antigens, Protozoan / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D005714:Gambia; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood / Q000276:immunology; D006801:Humans; D017780:Malaria Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D016778:Malaria, Falciparum / Q000097:blood / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000276:immunology* / Q000302:isolation & purification; D015800:Protozoan Proteins / Q000276:immunology; D012016:Reference Values; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017780:Malaria Vaccines; D015800:Protozoan Proteins; D014614:Vaccines, Synthetic; C041595:circumsporozoite protein, Protozoan