Viewing Study NCT00000847



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00000847
Status: COMPLETED
Last Update Posted: 2021-11-04
First Post: 1999-11-02

Brief Title: A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers
Status: COMPLETED
Status Verified Date: 2021-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To evaluate the safety and immunogenicity of high-titered ALVAC-HIV MN120TMG vCP205 given sequentially or simultaneously with rgp120HIV-1SF2 in MF59 adjuvant emulsion in HIV-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 vCP205 expresses proteins from two strains of HIV MN and LAI rgp120HIV-1SF2 expresses proteins from a different strain of HIV This study will help to show how the immune system responds to proteins from more than one strain of virus
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 vCP205 expresses proteins from two strains of HIV MN and LAI rgp120HIV-1SF2 expresses proteins from a different strain of HIV This study will help to show how the immune system responds to proteins from more than one strain of virus

Six groups of 25 volunteers each are randomized to receive simultaneous or sequential doses of ALVAC-HIV vCP205 and SF2 rgp120 or control vaccines ALVAC-RG rabies glycoprotein vCP65 or BIOCINE Placebo Vaccine 2 In each group 21 volunteers receive vaccine and 4 receive control vaccines Volunteers are stratified by lower or higher risk sexual behavior Immunizations are given to three groups at months 0 1 3 6 9 and 12 and to the other three groups at months 0 1 6 9 and 12 Volunteers are followed for 24 months

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
10573 REGISTRY DAIDS ES Registry Number None