A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: ALVAC-HIV MN120TMG (vCP205)
* Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
* Biological: rgp120/HIV-1 SF-2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ALVAC-HIV MN120TMG (vCP205)|nan|
|Biological: ALVAC-RG Rabies Glycoprotein (vCP65)|nan|
|Biological: rgp120/HIV-1 SF-2|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines, Synthetic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, HIV Preventive Vaccine