| Title: |
Efficacy Testing of Recombinant Human Immunodeficiency Virus (HIV) gp160 as a Therapeutic Vaccine in Early-Stage HIV-1-Infected Volunteers |
| Authors: |
Birx, Deborah L.; Loomis-Price, Lawrence D.; Aronson, Naomi; Brundage, John; Davis, Charles; Deyton, Lawrence; Garner, Robin; Gordin, Fred; Henry, David; Holloway, William; Kerkering, Thomas; Luskin-Hawk, Roberta; McNeil, John; Michael, Nelson; Pierce, Phillip Foster; Poretz, Donald; Ratto-Kim, Silvia; Renzullo, Phil; Ruiz, Nancy; Sitz, Karl; Smith, Gale; Tacket, Carol; Thompson, Melanie; Tramont, Edmond; Yangco, Bienvenido; Yarrish, Robert; Redfleld, Robert R.; and the rgp160 Phase II Vaccine Investigators |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2000 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
Major Articles |
| Description: |
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. |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://jid.oxfordjournals.org/cgi/content/short/181/3/881; http://dx.doi.org/10.1086/315308 |
| DOI: |
10.1086/315308 |
| Availability: |
http://jid.oxfordjournals.org/cgi/content/short/181/3/881; https://doi.org/10.1086/315308 |
| Rights: |
Copyright (C) 2000, Infectious Diseases Society of America |
| Accession Number: |
edsbas.A3A17B2C |
| Database: |
BASE |