Rochester, New York 14642

  • HIV Infections

Purpose:

To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2 vaccine in HIV-negative volunteers. Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205.


Study summary:

Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205. Volunteers are randomized to receive immunization with either ALVAC-HIV vCP205 or ALVAC-RG rabies glycoprotein (vCP65) at days 0, 7, 14, and 21, followed by boost with rgp120/HIV-1 SF2 at days 28 and 84. A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by boost with placebo.


Criteria:

Inclusion Criteria Volunteers must have: - Normal history and physical exam. - Negative ELISA and Western blot for HIV. - CD4 count >= 400 cells/mm3. - Normal urine dipstick with esterase and nitrite. - Lower-risk sexual behavior. Exclusion Criteria Co-existing Condition: Volunteers 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. Volunteers 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.


NCT ID:

NCT00001076


Primary Contact:

Study Chair
Belshe R


Backup Contact:

N/A


Location Contact:

Rochester, New York 14642
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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