A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers
- Conditions
- HIV Infections
- Registration Number
- NCT00001055
- Brief Summary
To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative volunteers.
ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease.
- Detailed Description
ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease.
Volunteers are randomized to receive doses of ALVAC-HIV vCP205 or ALVAC-HIV vCP65 control or both according to varying schedules over 12 months (was 6 months, amended 11/17/95) with a 12 month follow up. \[AS PER AMENDMENT 5/29/98: One additional follow-up visit is required at 30-36 months.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
UAB AVEG
🇺🇸Birmingham, Alabama, United States
Univ. of Rochester AVEG
🇺🇸Rochester, New York, United States
UW - Seattle AVEG
🇺🇸Seattle, Washington, United States
JHU AVEG
🇺🇸Baltimore, Maryland, United States
St. Louis Univ. School of Medicine AVEG
🇺🇸Saint Louis, Missouri, United States
Vanderbilt Univ. Hosp. AVEG
🇺🇸Nashville, Tennessee, United States