Safety and immunogenicity of a recombinant nonglycosylated erythrocyte binding antigen 175 Region II malaria vaccine in healthy adults living in an area where malaria is not endemic

Clin Vaccine Immunol. 2010 Oct;17(10):1552-9. doi: 10.1128/CVI.00082-10. Epub 2010 Aug 11.

Abstract

Erythrocyte binding antigen region II (EBA-175) is a conserved antigen of Plasmodium falciparum that is involved in binding of the parasite to the host's erythrocytes. We evaluated the safety and immunogenicity of a recombinant EBA-175 vaccine with aluminum phosphate adjuvant in healthy young adults living in the United States. Eighteen subjects/group received ascending doses (5, 20, 80, or 160 μg) of the vaccine at 0, 1, and 6 months; 8 subjects received placebo. Most of the injection site and systemic reactions were mild to moderate in intensity. After 2 or 3 doses of the vaccine at any concentration, antibody levels measured by enzyme-linked immunosorbent assay were significantly higher than those for the placebo group. Sera from subjects who received 3 doses of the vaccine at any concentration inhibited the growth of erythrocyte-stage P. falciparum at low levels compared to sera from placebo recipients or preimmune sera. In conclusion, the EBA-175 vaccine with adjuvant was safe and immunogenic in malaria-naïve subjects.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, N.I.H., Intramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adolescent
  • Adult
  • Aluminum Compounds / administration & dosage
  • Antibodies, Protozoan / blood
  • Antigens, Protozoan / administration & dosage
  • Antigens, Protozoan / adverse effects*
  • Antigens, Protozoan / immunology*
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Human Experimentation
  • Humans
  • Immunization, Secondary / methods
  • Malaria Vaccines / administration & dosage
  • Malaria Vaccines / adverse effects*
  • Malaria Vaccines / immunology*
  • Malaria, Falciparum / prevention & control*
  • Male
  • Phosphates / administration & dosage
  • Placebos / administration & dosage
  • Plasmodium falciparum / growth & development
  • Plasmodium falciparum / immunology
  • Protozoan Proteins / administration & dosage
  • Protozoan Proteins / adverse effects*
  • Protozoan Proteins / immunology*
  • United States
  • Vaccination / methods
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology
  • Young Adult

Substances

  • Adjuvants, Immunologic
  • Aluminum Compounds
  • Antibodies, Protozoan
  • Antigens, Protozoan
  • Malaria Vaccines
  • Phosphates
  • Placebos
  • Protozoan Proteins
  • Vaccines, Synthetic
  • erythrocyte-binding antigen 175, Plasmodium
  • aluminum phosphate