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.
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| Abstract |
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.
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| Authors | D L Birx, L D Loomis-Price, N Aronson, J Brundage, C Davis, L Deyton, R Garner, F Gordin, D Henry, W Holloway, T Kerkering, R Luskin-Hawk, J McNeil, N Michael, P Foster Pierce, D Poretz, S Ratto-Kim, P Renzullo, N Ruiz, K Sitz, G Smith, C Tacket, M Thompson, E Tramont, B Yangco, R Yarrish, R R Redfield |
| Journal | The Journal of infectious diseases (J Infect Dis) Vol. 181 Issue 3 Pg. 881-9 (Mar 2000) ISSN: 0022-1899 [Print] United States |
| PMID | 10720508 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.) |
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