HIV Infections
Conditions
Keywords
Vaccines, Synthetic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, HIV Preventive Vaccine
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.
Interventions
BIOLOGICALALVAC-HIV MN120TMGNP (vCP300)
BIOLOGICALALVAC-RG Rabies Glycoprotein (vCP65)
BIOLOGICALrgp120/HIV-1 SF-2
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Volunteers must have: * Normal history and physical exam. * ELISA and Western blot negative for HIV. * CD4 count \>= 400 cells/mm3. * 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: 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. Identifiable high-risk behavior for HIV infection, such as * injection drug use within past 12 months. * higher or intermediate risk sexual behavior.
Countries
United States
Outcome results
None listed