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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000745

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

1991-05-31

Last updated

2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

Brief 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.

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.

Interventions

BIOLOGICALHepatitis B Vaccine (Recombinant)

BIOLOGICALgp160 Vaccine (MicroGeneSys)

Study design

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026