Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000795
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 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 Multivalent HIV-1 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 in healthy adult volunteers the safety and immunogenicity of multivalent HIV-1 peptide immunogen a formulation of HIV-1 gp120 principal neutralizing domain PND branched synthetic peptides from 15 viral strains representative of diverse worldwide isolates
Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates potentially providing for wide coverage of geographically isolated epidemics
Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates potentially providing for wide coverage of geographically isolated epidemics
Detailed Description:
Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates potentially providing for wide coverage of geographically isolated epidemics
Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine At each dose level 12 volunteers receive vaccine and two receive placebo At least eight volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers are entered at the high dose Intramuscular injections are given on days 0 28 and 168 and patients are followed for a minimum of 48 weeks after the initial immunization Approximately 13 clinical visits are required
Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine At each dose level 12 volunteers receive vaccine and two receive placebo At least eight volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers are entered at the high dose Intramuscular injections are given on days 0 28 and 168 and patients are followed for a minimum of 48 weeks after the initial immunization Approximately 13 clinical 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?: