Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults.
ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)-negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferative responses to glycoprotein 120 E were induced in 63% of the volunteers, and HIV-specific CD8 cytotoxic T lymphocyte responses were induced in 24%. Antibody responses increased in frequency and magnitude in association with the dose level of AIDSVAX B/E. Binding and neutralizing antibodies to the MN strain were induced in 100% and 98%, respectively, of the volunteers receiving 600 microg of AIDSVAX B/E, and such antibodies to E strains were induced in 96% and 71%, respectively, of these volunteers. This vaccine combination was well tolerated and was immunogenic, meeting milestones for advancement to phase 3 evaluation.
Royal Thai Component, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. sorachain@afrims.org
Sorachai
S
Nitayaphan
Punnee
P
Pitisuttithum
Chitraporn
C
Karnasuta
Chirapa
C
Eamsila
Mark
M
de Souza
Patricia
P
Morgan
Victoria
V
Polonis
Michael
M
Benenson
Tom
T
VanCott
Silvia
S
Ratto-Kim
Jerome
J
Kim
Darawan
D
Thapinta
Robin
R
Garner
Valai
V
Bussaratid
Pricha
P
Singharaj
Raphaelle
R
el-Habib
Sanjay
S
Gurunathan
William
W
Heyward
Deborah
D
Birx
John
J
McNeil
Arthur E
AE
Brown
D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D000328:Adult; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D003602:Cytotoxicity, Immunologic; D005260:Female; D015483:HIV Antibodies / Q000096:biosynthesis / Q000097:blood; D015699:HIV Envelope Protein gp120 / Q000276:immunology / Q000494:pharmacology; D015658:HIV Infections / Q000097:blood / Q000276:immunology* / Q000517:prevention & control*; D018023:HIV Seronegativity / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D013785:Thailand; D013997:Time Factors; D014611:Vaccination
D016915:AIDS Vaccines; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120