A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 140
- Locations
- 6
Study Overview
Brief Summary
To evaluate, in HIV-negative volunteers, the safety and immunogenicity of ALVAC-HIV MN120TMGNP (vCP300) followed by or combined with boosting using rgp120/HIV-1SF2. To compare ALVAC-HIV vCP300 with ALVAC-RG rabies glycoprotein (vCP65) as a control. To evaluate an accelerated immunization schedule at 0, 1, 3, and 6 months versus 0, 1, 6, and 9 months.
The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.
Detailed Description
The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.
Volunteers are randomized to one of seven groups to receive immunizations with either ALVAC-HIV vCP300 or ALVAC-RG vCP65 (control), plus simultaneous or sequential boosting with rgp120/HIV-1SF2 or placebo. Immunizations are given at 0, 1, 6, and 9 months or 0, 1, 3, and 6 months. Volunteers are followed for at least 24 months.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Volunteers must have:
- •Normal history and physical exam.
- •ELISA and Western blot negative for HIV.
- •CD4 count >= 400 cells/mm
- •Normal urine dipstick with esterase and nitrite.
- •Lower risk sexual behavior.
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.
- •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.
- •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:
- •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:
- •Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as
- •injection drug use within past 12 months.
- •higher or intermediate risk sexual behavior.