title: Phase I clinical trial of a recombinant malaria vaccine consisting of the circumsporozoite repeat region of Plasmodium falciparum coupled to hepatitis B surface antigen.
abstract: R16HBsAg is an experimental recombinant malaria vaccine consisting of 16 repeats of a four amino acid sequence (Asn-Ala-Asn-Pro or NANP) of the circumsporozoite (CS) protein of Plasmodium falciparum expressed as a fusion protein with the recombinant hepatitis B virus surface antigen (HBsAg) produced by yeast cells. Twenty male volunteers were experimentally vaccinated with the product, as well as with two doses of the commercial recombinant HBsAg vaccine Engerix B (Smith Kline Beecham Biologicals, Rixensart, Belgium) at intervals during a period of 18 months. No serious side effects were observed. Circulating antibodies to recombinant CS antigen (R32tet32) developed in all volunteers and persisted in most cases over ten months. Anti-HBs antibody production was poor initially, but a single dose of the commercial hepatitis B vaccine was sufficient to elevate these titers to high levels in all but two volunteers.
authors.affiliation: Institute of Internal Medicine, University of Nijmegen, The Netherlands.
authors.forename: S G
authors.initials: SG
authors.lastname: Vreden
authors.forename: J P
authors.initials: JP
authors.lastname: Verhave
authors.forename: T
authors.initials: T
authors.lastname: Oettinger
authors.forename: R W
authors.initials: RW
authors.lastname: Sauerwein
authors.forename: J H
authors.initials: JH
authors.lastname: Meuwissen
mesh_terms: D000328:Adult; D000595:Amino Acid Sequence; D000818:Animals; D000953:Antigens, Protozoan / Q000276:immunology / Q000627:therapeutic use*; D004341:Drug Evaluation; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines; D006801:Humans; D016778:Malaria, Falciparum / Q000517:prevention & control*; D008297:Male; D008969:Molecular Sequence Data; D010963:Plasmodium falciparum / Q000276:immunology*; D015800:Protozoan Proteins; D016052:Protozoan Vaccines / Q000276:immunology*; D012091:Repetitive Sequences, Nucleic Acid; D014614:Vaccines, Synthetic / Q000276:immunology*; D014761:Viral Hepatitis Vaccines / Q000627:therapeutic use
chemical_list: D000953:Antigens, Protozoan; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D015800:Protozoan Proteins; D016052:Protozoan Vaccines; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines; C041595:circumsporozoite protein, Protozoan