Breakthrough infections during phase 1 and 2 prime-boost HIV-1 vaccine trials with canarypox vectors (ALVAC) and booster dose of recombinant gp120 or gp160.
Candidate human immunodeficiency virus (HIV)-1 vaccines that elicit cytotoxic T lymphocytes may modulate HIV infection, requiring a prototype evaluation to assess participants who become infected with HIV. Of 1497 participants in canarypox HIV-1 vaccine prime-boost trials, 28 (1.9%) acquired HIV-1 infection after vaccination. Median plasma HIV-1 RNA levels (vaccinees, 4.78 log10 copies/mL; placebo recipients, 4.27 log10 copies/mL) and CD4 cell counts (vaccinees, 552 cells/mm3; placebo recipients, 657 cells/mm3) before administration of antiretroviral therapy (ART) and time to a composite end point (plasma HIV-1 RNA level >55,000 copies/mL, CD4 cell count <350 cells/mm3, or initiation of ART) did not differ significantly between vaccinees and placebo recipients (P =.4, P =.1, and P =.7, respectively). Persons who acquire HIV-1 infection while enrolled in HIV-1 vaccine trials can be successfully followed after infection, to determine whether vaccines alter the course of HIV-1 infection.
Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Deborah
D
Lee
Barney S
BS
Graham
Ya-Lin
YL
Chiu
Peter B
PB
Gilbert
M Juliana
MJ
McElrath
Robert B
RB
Belshe
Susan P
SP
Buchbinder
Haynes W
HW
Sheppard
Beryl A
BA
Koblin
Kenneth H
KH
Mayer
Michael C
MC
Keefer
Mark J
MJ
Mulligan
Connie L
CL
Celum
D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000276:immunology; D018150:Avipoxvirus / Q000235:genetics*; D004311:Double-Blind Method; D005260:Female; D005822:Genetic Vectors / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology; D015699:HIV Envelope Protein gp120 / Q000008:administration & dosage* / Q000235:genetics / Q000276:immunology; D019302:HIV Envelope Protein gp160 / Q000008:administration & dosage* / Q000235:genetics / Q000276:immunology; D015658:HIV Infections / Q000503:physiopathology* / Q000517:prevention & control; D015497:HIV-1 / Q000472:pathogenicity*; D006801:Humans; D007114:Immunization; D007117:Immunization, Secondary; D008297:Male; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology
D016915:AIDS Vaccines; C468116:ALVAC-HIV vCP1452; C468115:ALVAC-HIV-1 vCP205; D015699:HIV Envelope Protein gp120; D019302:HIV Envelope Protein gp160; D012367:RNA, Viral; D011994:Recombinant Proteins