A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali.
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.
Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry BP 1805 Bamako, University of Bamako, Mali, Malaysia. isagara@mrtcbko.org
Issaka
I
Sagara
Alassane
A
Dicko
Ruth D
RD
Ellis
Michael P
MP
Fay
Sory I
SI
Diawara
Mahamadoun H
MH
Assadou
Mahamadou S
MS
Sissoko
Mamady
M
Kone
Abdoulbaki I
AI
Diallo
Renion
R
Saye
Merepen A
MA
Guindo
Ousmane
O
Kante
Mohamed B
MB
Niambele
Kazutoyo
K
Miura
Gregory E D
GE
Mullen
Mark
M
Pierce
Laura B
LB
Martin
Amagana
A
Dolo
Dapa A
DA
Diallo
Ogobara K
OK
Doumbo
Louis H
LH
Miller
Allan
A
Saul
D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000536:Aluminum Hydroxide / Q000276:immunology / Q000627:therapeutic use; D000740:Anemia / Q000150:complications / Q000188:drug therapy; D000818:Animals; D000917:Antibody Formation / Q000187:drug effects; D000953:Antigens, Protozoan / Q000276:immunology / Q000627:therapeutic use; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D017780:Malaria Vaccines / Q000627:therapeutic use*; D016778:Malaria, Falciparum / Q000150:complications / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D008302:Mali; D010963:Plasmodium falciparum / Q000276:immunology; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000953:Antigens, Protozoan; D006454:Hemoglobins; D017780:Malaria Vaccines; D000536:Aluminum Hydroxide