A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

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

Keywords

ClinConnect Summary

A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.

Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0, 1, and 6 or at months 0, 2, and 8. For each immunization schedule, ten volunteers receive vaccine and two volunteers receive placebo. Per amendment, volunteers receive a fourth immunization of 80...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Subjects must have:
• • Normal history and physical exam.
• • Negative test for HIV by ELISA within 6 weeks prior to immunization.
• • CD4 count \>= 400 cells/mm3.
• • Normal urine dipstick with esterase and nitrate.
• • No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications.
• • Exclusion Criteria
• Co-existing Condition:
• Subjects with the following conditions are excluded:
• • Positive for hepatitis B surface antigen.
• • Medical or psychiatric condition or occupational responsibilities that preclude compliance.
• • Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (\> 6 months) infection, subject is eligible).
• • Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
• Subjects with the following prior conditions are excluded:
• • History of anaphylaxis or other serious adverse reactions to vaccines.
• Prior Medication:
• Excluded:
• • Prior HIV vaccines.
• • Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
• • Experimental agents within the past 30 days.
• Prior Treatment:
• Excluded:
• • Blood products or immunoglobulin within the past 6 months.
• Higher risk behavior for HIV infection as determined by screening questionnaire, including:
• • History of injection drug use within 12 months prior to study entry.
• • Higher or intermediate risk sexual behavior.