Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000846
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen Given by IM Injection in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally in HIV-1 Uninfected 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 Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen Given by IM Injection in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally in HIV-1 Uninfected Volunteers
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 safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization parental priming followed by oral boosting
Detailed Description:
After the prescreening volunteers will be randomized into Group I or Group II Each group will contain 16 volunteers At least 5 volunteers in each group must be women At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh At months 1 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo Follow up will be conducted
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?: