Vaccination of vaccinia-naive adults with human immunodeficiency virus type 1 gp160 recombinant vaccinia virus in a blinded, controlled, randomized clinical trial. The AIDS Vaccine Clinical Trials Network.
The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) gp160 recombinant vaccinia virus (HIVAC-1e) vaccine was evaluated in vaccinia-naive, healthy adults at low risk for acquiring HIV-1 infection. Volunteers (n = 36) were randomized to receive HIVAC-1e or control vaccinia virus at two dosages by bifurcated needle puncture at 0 and 2 months; 12 HIVAC-1e and 6 control vaccinia virus recipients received either 10(6) or 10(7) pfu/mL at each inoculation. There was no significant difference in lesion size, level of viral replication, or systemic symptoms after vaccination with HIVAC-1e or control vaccinia virus. Of 22 HIVAC-1e recipients with lesion formation, 16 developed low-titer gp160-specific antibody responses detectable by Western blot. The peak response occurred between days 70 and 120 and was still detectable at day 365 in 9 of 18 vaccinees. gp160-specific lymphoproliferative responses were detected in 5 of 10 vaccinees. Vaccination with HIVAC-1e was safe in vaccinia-naive, healthy adults and could induce both humoral and cell-mediated gp160-specific immune responses.
Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232.
B S
BS
Graham
R B
RB
Belshe
M L
ML
Clements
R
R
Dolin
L
L
Corey
P F
PF
Wright
G J
GJ
Gorse
K
K
Midthun
M C
MC
Keefer
N J
NJ
Roberts
D016915:AIDS Vaccines / Q000009:adverse effects* / Q000276:immunology; D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control*; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D015496:CD4-Positive T-Lymphocytes; D004311:Double-Blind Method; D005260:Female; D015686:Gene Products, env / Q000276:immunology; D015483:HIV Antibodies / Q000096:biosynthesis; D019302:HIV Envelope Protein gp160; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D007958:Leukocyte Count; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D011498:Protein Precursors / Q000276:immunology; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology; D014616:Vaccinia virus / Q000235:genetics / Q000276:immunology* / Q000502:physiology; D014779:Virus Replication
D016915:AIDS Vaccines; D000914:Antibodies, Viral; D015686:Gene Products, env; D015483:HIV Antibodies; D019302:HIV Envelope Protein gp160; C067702:HIVAC-1e; D011498:Protein Precursors; D014614:Vaccines, Synthetic