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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

Phase 1
Completed
Conditions
HIV Infections
Registration Number
NCT00001072
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

JHU AVEG

🇺🇸

Baltimore, Maryland, United States

Vanderbilt Univ. Hosp. AVEG

🇺🇸

Nashville, Tennessee, United States

UAB AVEG

🇺🇸

Birmingham, Alabama, United States

UW - Seattle AVEG

🇺🇸

Seattle, Washington, United States

St. Louis Univ. School of Medicine AVEG

🇺🇸

Saint Louis, Missouri, United States

Univ. of Rochester AVEG

🇺🇸

Rochester, New York, United States

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