Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S

Summary

The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection. The RTS,S vaccine contains a malaria protein in combination with a portion of the commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd vaccination.

Timeline

Start

2001-04

Primary completion

2002-02

Completion

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Publications

• Cummings JF, Polhemus ME, Kester KE, Ockenhouse CF, Gasser RA Jr, Coyne P, Wortmann G, Nielsen RK, Schaecher K, Holland CA, Krzych U, Tornieporth N, Soisson LA, Angov E, Heppner DG; RTS,S Vaccine Evaluation Group. A phase IIa, randomized, double-blind, safety, immunogenicity and efficacy trial of Plasmodium falciparum vaccine antigens merozoite surface protein 1 and RTS,S formulated with AS02 adjuvant in healthy, malaria-naive adults. Vaccine. 2024 Apr 30;42(12):3066-3074. doi: 10.1016/j.vaccine.2024.03.072. Epub 2024 Apr 6.

Drugs

Indications