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.
Sagara
Issaka
I
Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry BP 1805 Bamako, University of Bamako, Mali, Malaysia. isagara@mrtcbko.org
Dicko
Alassane
A
Ellis
Ruth D
RD
Fay
Michael P
MP
Diawara
Sory I
SI
Assadou
Mahamadoun H
MH
Sissoko
Mahamadou S
MS
Kone
Mamady
M
Diallo
Abdoulbaki I
AI
Saye
Renion
R
Guindo
Merepen A
MA
Kante
Ousmane
O
Niambele
Mohamed B
MB
Miura
Kazutoyo
K
Mullen
Gregory E D
GE
Pierce
Mark
M
Martin
Laura B
LB
Dolo
Amagana
A
Diallo
Dapa A
DA
Doumbo
Ogobara K
OK
Miller
Louis H
LH
Saul
Allan
A
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