Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001076
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 Volunteers to Evaluate Accelerated Vaccine Schedules
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 Volunteers to Evaluate Accelerated Vaccine Schedules
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 an accelerated schedule of recombinant canarypox vaccine ALVAC-HIV MN120TMG vCP205 versus control followed by boost with rgp120HIV-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
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:
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 rgp120HIV-1 SF2 at days 28 and 84 A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by boost with placebo
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 rgp120HIV-1 SF2 at days 28 and 84 A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by boost with placebo
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 |
|---|---|---|---|
| 10579 | REGISTRY | DAIDS ES Registry Number | None |