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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 volunteer...

Gender

ALL

Eligibility criteria

• • 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.