Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000798
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
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 Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
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 evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1 MN PND peptide for oral administration in healthy HIV-1 seronegative adult volunteers at low risk for infection
Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine such as induction of mucosal immunity production of cytotoxic T cells and ease of administration An oral microparticulate vaccine containing a prototype synthetic peptide has been developed The microparticles can be degraded over time inducing both secretory and systemic immune responses
Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine such as induction of mucosal immunity production of cytotoxic T cells and ease of administration An oral microparticulate vaccine containing a prototype synthetic peptide has been developed The microparticles can be degraded over time inducing both secretory and systemic immune responses
Detailed Description:
Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine such as induction of mucosal immunity production of cytotoxic T cells and ease of administration An oral microparticulate vaccine containing a prototype synthetic peptide has been developed The microparticles can be degraded over time inducing both secretory and systemic immune responses
Twelve volunteers per dose regimen will receive oral microparticulate multivalent HIV-1 peptide vaccine at months 0 1 and 6 either daily as a low dose for 3 days or a single higher dose Additionally four volunteers per regimen will receive placebo Volunteers are followed for 1 year They will be contacted once or twice yearly for 5 years to check on health status
Twelve volunteers per dose regimen will receive oral microparticulate multivalent HIV-1 peptide vaccine at months 0 1 and 6 either daily as a low dose for 3 days or a single higher dose Additionally four volunteers per regimen will receive placebo Volunteers are followed for 1 year They will be contacted once or twice yearly for 5 years to check on health status
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?: