A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers

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

Keywords

ClinConnect Summary

A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular responses have been augmented by the combination of two recombinant vaccines, especially in vaccinia naive individuals.

In Part A, 28 healthy volunteers (15 vaccinia-immune and 13 vaccinia-naive) are randomized to receive intramuscular injections of ALVAC gp160 MN at a dose of 1 million TCID50 or ALVAC rabies glycoprotein as a control at months 0 and 2. In Part B, 90 healthy volunteers (60 vaccinia immune an...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Subjects must have:
• • Normal history and physical exam.
• • Negative ELISA for HIV.
• • CD4 count \>= 400 cells/mm3.
• • Normal urine dipstick with esterase and nitrite.
• • Lower risk sexual behavior.
• NOTE:
• • No more than 10 percent of participants will be older than 50 years.
• Prior Medication:
• Allowed:
• • Prior smallpox vaccination.
• • Exclusion Criteria
• Co-existing Condition:
• Subjects with the following symptoms or conditions are excluded:
• • Positive hepatitis B surface antigen.
• • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
• • Occupational responsibilities that preclude compliance.
• • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
• • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
• • Allergy to egg products or neomycin.
• • Occupational exposure to birds.
• Subjects with the following prior conditions are excluded:
• • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
• • History of anaphylaxis or other serious adverse reactions to vaccines.
• • Prior immunization against rabies.
• • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
• • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
• • History of cancer unless there has been surgical excision that is considered to have achieved cure.
• Prior Medication:
• Excluded:
• • Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
• • Experimental agents within 30 days prior to study entry.
• • Prior HIV vaccines.
• • Prior rabies immunization.
• Prior Treatment:
• Excluded:
• • Blood products or immunoglobulin within 6 months prior to study entry. It is STRONGLY RECOMMENDED that any activity that might expose subject to HIV (unprotected sex or needle sharing) be avoided.