Efficacy testing of recombinant human immunodeficiency virus (HIV) gp160 as a therapeutic vaccine in early-stage HIV-1-infected volunteers. rgp160 Phase II Vaccine Investigators.
A phase II efficacy trial was conducted with recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein gp160 (rgp160) in 608 HIV-infected, asymptomatic volunteers with CD4+ cell counts >400 cells/mm3. During a 5-year study, volunteers received a 6-shot primary series of immunizations with either rgp160 or placebo over 6 months, followed by booster immunizations every 2 months. Repeated vaccination with rgp160 was safe and persistently immunogenic. Adequate follow-up and acquisition of endpoints allowed for definitive interpretation of the trial results. There was no evidence that rgp160 has efficacy as a therapeutic vaccine in early-stage HIV infection, as measured at primary endpoints (50% decline in CD4+ cell count or disease progression to Walter Reed stage 4, 5, or 6) or secondary endpoints. A transient improvement was seen in the secondary CD4 endpoint for the vaccination compared with the placebo arm, but this did not translate into improved clinical outcome.
Birx
D L
DL
Walter Reed Army Institute of Research, Division of Retrovirology, Rockville, MD 20850, USA. dbirx@hiv.hjf.org
Loomis-Price
L D
LD
Aronson
N
N
Brundage
J
J
Davis
C
C
Deyton
L
L
Garner
R
R
Gordin
F
F
Henry
D
D
Holloway
W
W
Kerkering
T
T
Luskin-Hawk
R
R
McNeil
J
J
Michael
N
N
Foster Pierce
P
P
Poretz
D
D
Ratto-Kim
S
S
Renzullo
P
P
Ruiz
N
N
Sitz
K
K
Smith
G
G
Tacket
C
C
Thompson
M
M
Tramont
E
E
Yangco
B
B
Yarrish
R
R
Redfield
R R
RR
D016915:AIDS Vaccines / Q000627:therapeutic use*; D000163:Acquired Immunodeficiency Syndrome / Q000276:immunology / Q000628:therapy* / Q000821:virology; D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D005260:Female; D019302:HIV Envelope Protein gp160 / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins / Q000276:immunology; D014614:Vaccines, Synthetic / Q000627:therapeutic use*
D016915:AIDS Vaccines; D019302:HIV Envelope Protein gp160; D012367:RNA, Viral; D011994:Recombinant Proteins; D014614:Vaccines, Synthetic