Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000845
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b 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 HIV Lipopeptide Vaccine Component P3C541b 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 an HIV synthetic lipopeptide candidate vaccine component P3C541b at two dose levels administered subcutaneously sc in a randomized double-blind placebo controlled study
Detailed Description:
The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes Only volunteers possessing HLA alleles A33 B8 B27 B35 or Bw62 or any combination thereof will be enrolled in the study Subjects will be allocated to 1 of 2 study groups Group 1 will receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the placebo NOTE Enrollment for Group II wil not begin until at least 5 Group I participants have reached day 14 without serious adverse events
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?: