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CompletedNCT00000745Updated Nov 4, 2021

A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

A Phase 1 interventional study of Hepatitis B Vaccine (Recombinant) and gp160 Vaccine (MicroGeneSys) in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
72
Ages
18 Years to 50 Years
Sex
All
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Study summary

To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.

Read the detailed description

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.

Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B vaccine group will serve as an additional control for immunological evaluations. An optional fourth injection may be given 15-21 months following the initial inoculation.

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Conditions studied

  • HIV Infections

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Keywords

  • Vaccines, Synthetic
  • Vaccinia Virus
  • Viral Vaccines
  • HIV-1
  • HIV Envelope Protein gp160
  • AIDS Vaccines
  • HIV Seronegativity
  • HIV Preventive Vaccine
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In context

HIV Infections

4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 72 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Subjects must have:

  • Normal history and physical exam.
  • Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
  • T4 count >= 800 cells/mm3.
  • Normal chest x-ray and urinalysis.
  • Negative surface antibody and core antibody for hepatitis B.
  • Negative hepatitis B surface antigen.
  • Negative HIV p24 antigen test.
  • Normal skin reactivity by Merieux test.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

  • Positive PPD.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).

Subjects with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
  • Prior hepatitis B vaccination.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Prior Medication:

Excluded:

  • Prior hepatitis B vaccine.

Prior Treatment:

Excluded:

  • Prior blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:

  • Any history of IV drug use.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
  • More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
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Study design

Phase
Phase 1
Primary purpose
Prevention
Masking
Double
Enrollment
72 participants

Interventions

  • BiologicalHepatitis B Vaccine (Recombinant)
  • Biologicalgp160 Vaccine (MicroGeneSys)
06

Study locations

2 sites
  • JHU AVEG
    Pittsburgh, Pennsylvania, United States
  • Vanderbilt Univ. Hosp. AVEG
    Nashville, Tennessee 37232, United States
07

References and documents

Publications

  • Dolin R, Graham BS, Greenberg SB, Tacket CO, Belshe RB, Midthun K, Clements ML, Gorse GJ, Horgan BW, Atmar RL, et al. The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network. Ann Intern Med. 1991 Jan 15;114(2):119-27. doi: 10.7326/0003-4819-114-2-119. PubMed 1984386 ↗
  • Archibald DW, Hebert CA, Sun D, Tacket CO. Salivary antibodies to human immunodeficiency virus type 1 in a phase I AIDS vaccine trial. J Acquir Immune Defic Syndr (1988). 1990;3(10):954-8. PubMed 2204698 ↗
  • Westblom TU, Belshe RB, Gorse GJ, Anderson EL, Berry CF. Characteristics of a population volunteering for human immunodeficiency virus immunization. NIAID AIDS Clinical Trials Network. Int J STD AIDS. 1990 Mar;1(2):126-8. doi: 10.1177/095646249000100211. PubMed 2092787 ↗
  • Keefer MC, Wolff M, Gorse GJ, Graham BS, Corey L, Clements-Mann ML, Verani-Ketter N, Erb S, Smith CM, Belshe RB, Wagner LJ, McElrath MJ, Schwartz DH, Fast P. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. doi: 10.1089/aid.1997.13.1163. PubMed 9310283 ↗
  • Tacket CO, Baqar S, Munoz C, Murphy JR. Lymphoproliferative responses to mitogens and HIV-1 envelope glycoprotein among volunteers vaccinated with recombinant gp160. AIDS Res Hum Retroviruses. 1990 Apr;6(4):535-42. doi: 10.1089/aid.1990.6.535. PubMed 2187503 ↗
  • Viscidi R, Ellerbeck E, Garrison L, Midthun K, Clements ML, Clayman B, Fernie B, Smith G. Characterization of serum antibody responses to recombinant HIV-1 gp160 vaccine by enzyme immunoassay. NIAID AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1990 Nov;6(11):1251-6. doi: 10.1089/aid.1990.6.1251. PubMed 1706607 ↗
  • Orentas RJ, Hildreth JE, Obah E, Polydefkis M, Smith GE, Clements ML, Siliciano RF. Induction of CD4+ human cytolytic T cells specific for HIV-infected cells by a gp160 subunit vaccine. Science. 1990 Jun 8;248(4960):1234-7. doi: 10.1126/science.2190315. PubMed 2190315 ↗
  • Clerici M, Berzofsky JA, Shearer GM, Tacket CO. Exposure to human immunodeficiency virus (HIV) type I indicated by HIV-specific T helper cell responses before detection of infection by polymerase chain reaction and serum antibodies [corrected]. J Infect Dis. 1991 Jul;164(1):178-82. doi: 10.1093/infdis/164.1.178. Erratum In: J Infect Dis 1991 Oct;164(4):832. PubMed 1829105 ↗
  • Bollinger RC, Quinn TC, Liu AY, Stanhope PE, Hammond SA, Viveen R, Clements ML, Siliciano RF. Cytokines from vaccine-induced HIV-1 specific cytotoxic T lymphocytes: effects on viral replication. AIDS Res Hum Retroviruses. 1993 Nov;9(11):1067-77. doi: 10.1089/aid.1993.9.1067. PubMed 7906131 ↗
  • Polydefkis M, Koenig S, Flexner C, Obah E, Gebo K, Chakrabarti S, Earl PL, Moss B, Siliciano RF. Anchor sequence-dependent endogenous processing of human immunodeficiency virus 1 envelope glycoprotein gp160 for CD4+ T cell recognition. J Exp Med. 1990 Mar 1;171(3):875-87. doi: 10.1084/jem.171.3.875. PubMed 1968506 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000745
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Protein Sciences Corporation
Responsible party
Sponsor
First posted
Aug 31, 2001
Completion
May 1991
Last update
Nov 4, 2021

Study contacts

Belshe R
study chair
Clements ML
study chair
Couch R
study chair
Dolin R
study chair
Levine M
study chair
Wright P
study chair
View the source record on ClinicalTrials.gov ↗

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