Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000775
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of UBI SynVac HIV-1 MN Octameric V3 Peptide Vaccine
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 UBI SynVac HIV-1 MN Octameric V3 Peptide Vaccine
Status:
COMPLETED
Status Verified Date:
2002-10
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 determine the safety immunogenicity and optimal dose of rgp120HIV-1MN octameric V3 peptide vaccine SynVac in healthy volunteers
It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1 SynVac is a synthetic candidate vaccine based on eight V3-derived peptides attached to a heptalysyl core to form radial octamers In animal studies the vaccine appears safe and demonstrates the capability for producing immune responses
It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1 SynVac is a synthetic candidate vaccine based on eight V3-derived peptides attached to a heptalysyl core to form radial octamers In animal studies the vaccine appears safe and demonstrates the capability for producing immune responses
Detailed Description:
It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1 SynVac is a synthetic candidate vaccine based on eight V3-derived peptides attached to a heptalysyl core to form radial octamers In animal studies the vaccine appears safe and demonstrates the capability for producing immune responses
Twelve volunteers are entered at one of three dose levels of SynVac At each dose level 10 volunteers receive vaccine and two receive placebo At least eight volunteers at each dose level must be monitored for 1 week before subsequent volunteers are entered at the next higher level Intramuscular injections are given on day 0 28 and 168 Approximately 12 clinic visits are required
Twelve volunteers are entered at one of three dose levels of SynVac At each dose level 10 volunteers receive vaccine and two receive placebo At least eight volunteers at each dose level must be monitored for 1 week before subsequent volunteers are entered at the next higher level Intramuscular injections are given on day 0 28 and 168 Approximately 12 clinic visits are required
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?: