Phase I clinical trial of a recombinant malaria vaccine consisting of the circumsporozoite repeat region of Plasmodium falciparum coupled to hepatitis B surface antigen

Am J Trop Med Hyg. 1991 Nov;45(5):533-8. doi: 10.4269/ajtmh.1991.45.533.

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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Amino Acid Sequence
  • Animals
  • Antigens, Protozoan / immunology
  • Antigens, Protozoan / therapeutic use*
  • Drug Evaluation
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B Vaccines
  • Humans
  • Malaria, Falciparum / prevention & control*
  • Male
  • Molecular Sequence Data
  • Plasmodium falciparum / immunology*
  • Protozoan Proteins*
  • Protozoan Vaccines / immunology*
  • Repetitive Sequences, Nucleic Acid
  • Vaccines, Synthetic / immunology*
  • Viral Hepatitis Vaccines / therapeutic use

Substances

  • Antigens, Protozoan
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Protozoan Proteins
  • Protozoan Vaccines
  • Vaccines, Synthetic
  • Viral Hepatitis Vaccines
  • circumsporozoite protein, Protozoan