Phase I/II study of a candidate vaccine designed against the B and E subtypes of HIV-1.
A phase I/II trial of a candidate vaccine to prevent HIV infection was carried out in Bangkok, Thailand, testing AIDSVAX B/E (VaxGen, Inc., Brisbane, CA), a bivalent subunit vaccine prepared by combining recombinant gp120 from a subtype B virus (HIV-1MN) with gp120 from a subtype E virus (HIV-1A244) in alum adjuvant. The studies provide human data on the immunogenicity of various dose combination of non-subtype B vaccine antigens. The results suggest that AIDSVAX B/E is safe and immunogenic in humans. The optimal dose for humans in developing countries was 300 microg of each antigen (B and E). Clade E responses were measurably increased by immunizing with gp120 B/E over B alone. Using the B/E combination did not interfere with the response to either clade. Antibodies to AIDSVAX B/E were able to bind to oligomeric gp120 on the surface of cells infected with primary isolates of HIV-1.
Pitisuttithum
Punnee
P
Vaccine Trial Center, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. tmppt@mahidol.ac.th
Berman
Phillip W
PW
Phonrat
Benjaluck
B
Suntharasamai
Pravan
P
Raktham
Suwanee
S
Srisuwanvilai
La-Ong
LO
Hirunras
Krit
K
Kitayaporn
Dwip
D
Kaewkangwal
Jaranit
J
Migasena
Sricharoen
S
Sheppard
Haynes W
HW
Li
Elizabeth
E
Chernow
Marlene
M
Peterson
Michael L
ML
Shibata
Riri
R
Heyward
William L
WL
Francis
Donald P
DP
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000534:Alum Compounds; D005260:Female; D015483:HIV Antibodies / Q000097:blood; D015699:HIV Envelope Protein gp120 / Q000235:genetics / Q000276:immunology*; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D015497:HIV-1 / Q000145:classification* / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000276:immunology; D015819:Substance Abuse, Intravenous / Q000150:complications; D013785:Thailand; D014611:Vaccination
D016915:AIDS Vaccines; C112734:AIDSVAX; D000276:Adjuvants, Immunologic; D000534:Alum Compounds; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120; D011994:Recombinant Proteins; C041524:aluminum sulfate