Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine

J Infect Dis. 1995 Jun;171(6):1576-85. doi: 10.1093/infdis/171.6.1576.


Twenty malaria-naive volunteers received a recombinant Plasmodium falciparum malaria vaccine (RTS,S) containing 19 NANP repeats and the carboxy terminus (amino acids 210-398) of the circumsporozoite (CS) antigen coexpressed in yeast with hepatitis B surface antigen. Ten received vaccine adjuvanted with alum, and 10 received vaccine adjuvanted with alum plus 3-deacylated monophosphoryl lipid A (MPL). Both formulations were well tolerated and immunogenic. MPL enhanced CS antibody levels (measured by ELISA, immunofluorescence, and inhibition of sporozoite invasion assays). After sporozoite challenge, 6 of 6 in the alum group and 6 of 8 in the alum-MPL group developed patent malaria. Protected subjects had higher levels of CS antibody titers on day of challenge than did nonprotected subjects. After immunization, 1 protected subject had increased cytotoxic T lymphocyte activity against CS and recall of memory T cell responses to RTS,S and selected CS.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Controlled Clinical Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Animals
  • Antibodies, Protozoan / biosynthesis*
  • Cytotoxicity, Immunologic
  • Hepatitis B Surface Antigens / immunology
  • Humans
  • Immunity, Cellular
  • Malaria Vaccines / adverse effects
  • Malaria Vaccines / immunology*
  • Malaria, Falciparum / prevention & control
  • Male
  • Plasmodium falciparum / immunology*
  • Protozoan Proteins / immunology
  • T-Lymphocytes, Cytotoxic / immunology
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology


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