A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)

A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)

To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers. Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

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

Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are vaccinated. In phase 1, at each participating unit, four volunteers receive a dose of gp160 (12.5 mcg); two volunteers receive placebo. Volunteers are monitored 1 month before proceeding to the second phase. In phase 2, four volunteers receive gp160 (50 mcg); two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for a minimum of 2 years. Volunteers may be offered an additional boost of the same preparation at 18 months. Per 07/28/92 amendment, 18 volunteers will receive 200 mcg gp160 in an unblinded study. Volunteers in phase 2 who received four doses of 50 mcg gp160 receive an additional boost of 200 mcg gp160 at 18-19 months post initial vaccination. Per 05/13/94 amendment, volunteers in phase 2 who received the additional 200 mcg boost receive another 200 mcg boost 18-24 months after the last injection (St. Louis University site only).

Inclusion Criteria

Patients must be:

• Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
• Available for 1 year of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• History of positive PPD (tuberculin test).
• Positive syphilis serology (e.g., VDRL).
• Positive for circulating hepatitis B antigen.

Patients with the following are excluded:

• They or their sexual partners have identifiable high-risk behavior for HIV infection.
• History of immunodeficiency or chronic illness.
• Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

• Immunosuppressive medications.

Prior Treatment:

Excluded:

• Blood transfusions or cryoprecipitates within the past 6 months.

Risk Behavior: Excluded:

• High-risk behavior for HIV infection.
• History of intravenous drug use.
• More than one sexual partner in the last 6 months.