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

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.
Authors	Issaka Sagara, Alassane Dicko, Ruth D Ellis, Michael P Fay, Sory I Diawara, Mahamadoun H Assadou, Mahamadou S Sissoko, Mamady Kone, Abdoulbaki I Diallo, Renion Saye, Merepen A Guindo, Ousmane Kante, Mohamed B Niambele, Kazutoyo Miura, Gregory E D Mullen, Mark Pierce, Laura B Martin, Amagana Dolo, Dapa A Diallo, Ogobara K Doumbo, Louis H Miller, Allan Saul
Journal	Vaccine (Vaccine) Vol. 27 Issue 23 Pg. 3090-8 (May 18 2009) ISSN: 0264-410X [Print] Netherlands
PMID	19428923 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Intramural)
Chemical References	Adjuvants, Immunologic Antigens, Protozoan Hemoglobins Malaria Vaccines Aluminum Hydroxide
Topics	Adjuvants, Immunologic (therapeutic use) Aluminum Hydroxide (immunology, therapeutic use) Anemia (complications, drug therapy) Animals Antibody Formation (drug effects) Antigens, Protozoan (immunology, therapeutic use) Child, Preschool Double-Blind Method Female Hemoglobins (analysis) Humans Malaria Vaccines (therapeutic use) Malaria, Falciparum (complications, immunology, prevention & control) Male Mali Plasmodium falciparum (immunology) Treatment Outcome

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