A human phase 1 vaccine clinical trial of the Plasmodium falciparum malaria vaccine candidate apical membrane antigen 1 in Montanide ISA720 adjuvant.
A dose escalating, placebo-controlled phase 1 trial was conducted to test the safety and immunogenicity of a vaccine containing recombinant Plasmodium falciparum apical membrane antigen 1 (AMA1) formulated in Montanide ISA720. Three groups of volunteers were vaccinated intramuscularly with 5 microg, 20 microg or 80 microg of AMA1, respectively, in 0.5 mL of formulation at 0, 3 and 6 months. Anti-AMA1 antibody levels and T cell stimulation indices were measured before and after each vaccination. No vaccine-related serious adverse events were recorded. Most subjects generated a mild to moderate, transient local reaction after the first vaccination. Three subjects developed a local reaction approximately 10 days following vaccination. Six of the 29 subjects seroconverted. Only one of these developed a high antibody titre. However, the interpretation of this trial was compromised by a loss of potency of the formulated vaccine during the course of the study.
Saul
Allan
A
The Cooperative Research Centre for Vaccine Technology, Brisbane, Qld, Australia. asaul@niaid.nih.gov
Lawrence
Greg
G
Allworth
Anthony
A
Elliott
Suzanne
S
Anderson
Karen
K
Rzepczyk
Christine
C
Martin
Laura B
LB
Taylor
Darrin
D
Eisen
Damon P
DP
Irving
David O
DO
Pye
David
D
Crewther
Pauline E
PE
Hodder
Anthony N
AN
Murphy
Vincent J
VJ
Anders
Robin F
RF
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood; D000953:Antigens, Protozoan / Q000276:immunology*; D005260:Female; D006168:Guinea Pigs; D006801:Humans; D017780:Malaria Vaccines / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D008353:Mannitol / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D008565:Membrane Proteins / Q000276:immunology*; D051379:Mice; D009829:Oleic Acids / Q000008:administration & dosage*; D010963:Plasmodium falciparum / Q000276:immunology*; D015800:Protozoan Proteins / Q000276:immunology*; D016037:Single-Blind Method; D013601:T-Lymphocytes / Q000276:immunology
D000276:Adjuvants, Immunologic; D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D017780:Malaria Vaccines; D008565:Membrane Proteins; D009829:Oleic Acids; D015800:Protozoan Proteins; C090077:apical membrane antigen I, Plasmodium; C001681:mannide monooleate; D008353:Mannitol