Immune responses to a recombinant human immunodeficiency virus type 1 (HIV-1) gpl60 vaccine among adults with advanced HIV infection. Massachusetts gp160 Working Group.

Abstract

OBJECTIVE:

To assess immunogenicity of recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccine (rgp160) in late HIV infection.

STUDY DESIGN/METHODS:

HIV-infected volunteers (n = 142), with CD4+ T lymphocyte counts of <400/mm3, were enrolled in a dose-comparison, open-label trial with stratification by CD4+ cell count, randomization to a primary series at two dose levels, and a sub-group receiving interferon-gamma (IFN-gamma) as an adjuvant. Subjects received booster doses of vaccine over a follow-up period of 18-28 months.

RESULTS:

At 6 and 12 months, 36% and 38% of participants, respectively, had new or augmented antibody titers (> or =4-fold increase) against one or more gpl60 epitopes (C1, V3, C41, 448C). Delayed-type hypersensitivity (DTH) to intradermal gpl60, initially not present in any participant, developed after immunization in 41%, with higher prevalence in participants receiving the lower dose of vaccine. Both antibody and skin test responses occurred in 20-25% of vaccine recipients. Virtually all antibody and skin test responses occurred in participants with initial CD4+ cell counts of >100 cells/mm3. IFN-gamma had no significant effect on immune response. Immunization was well tolerated. Trends in CD4+ cell count, clinical events, and laboratory findings correlated with baseline CD4+ T lymphocyte count stratum and not with immunization regimen. Opportunistic conditions occurred at expected rates. Viral load trends (p24 antigen in all participants and viral RNA by reverse transcription-polymerase chain reaction in a subset of 26 participants) did not correlate with immunization regimen.

CONCLUSION:

Immunization of patients with advanced HIV infection with rgpl60 resulted in new and augmented humoral and DTH responses, without unexpected significant adverse events or evident clinical benefits attributable to immunization.

• Authors: A DeMaria Jr, L Kunches, K Mayer, C Cohen, P Epstein, B Werner, J Day, J DeCristofaro, S Landers, Y Tang, W Coady
• Journal: Journal of human virology (J Hum Virol) 2000 Jul-Aug Vol. 3 Issue 4 Pg. 182-92 ISSN: 1090-9508 [Print] United States
• PMID: 10990166 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• AIDS Vaccines
• HIV Antibodies
• HIV Envelope Protein gp160
• Vaccines, Synthetic
• VaxSyn HIV-1 (gp160) vaccine

Topics

• AIDS Vaccines (immunology, therapeutic use)
• Adult
• CD4 Lymphocyte Count
• Disease Progression
• Female
• HIV Antibodies (blood)
• HIV Envelope Protein gp160 (genetics, immunology)
• HIV Infections (immunology, therapy)
• HIV-1 (immunology)
• Humans
• Hypersensitivity, Delayed
• Male
• Middle Aged
• Vaccines, Synthetic (immunology, therapeutic use)