A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

Vaccine. 2009 May 18;27(23):3090-8. doi: 10.1016/j.vaccine.2009.03.014. Epub 2009 Mar 25.

Abstract

A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel. Participants were healthy children 2-3 years old living in or near the village of Bancoumana, Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/microL/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin <8.5 g/dL, in the direction of lower hemoglobin in the children who received AMA1-C1, although these differences were not significant after correction for multiple tests. These differences were not seen in the second year of transmission.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, N.I.H., Intramural

MeSH terms

  • Adjuvants, Immunologic / therapeutic use
  • Aluminum Hydroxide / immunology
  • Aluminum Hydroxide / therapeutic use
  • Anemia / complications
  • Anemia / drug therapy
  • Animals
  • Antibody Formation / drug effects
  • Antigens, Protozoan / immunology
  • Antigens, Protozoan / therapeutic use
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Hemoglobins / analysis
  • Humans
  • Malaria Vaccines / therapeutic use*
  • Malaria, Falciparum / complications
  • Malaria, Falciparum / immunology
  • Malaria, Falciparum / prevention & control*
  • Male
  • Mali
  • Plasmodium falciparum / immunology
  • Treatment Outcome

Substances

  • Adjuvants, Immunologic
  • Antigens, Protozoan
  • Hemoglobins
  • Malaria Vaccines
  • Aluminum Hydroxide