Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001053
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Safety and Immunogenicity Study of HIV p17p24Ty-VLP in HIV-1 Seronegative 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 Study of HIV p17p24Ty-VLP in HIV-1 Seronegative Subjects
Status:
COMPLETED
Status Verified Date:
2021-10
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 HIV p17p24Ty-VLP virus-like particles vaccine in uninfected volunteers Specifically to determine whether the vaccine formulated with and without alum induces CD8 cytotoxic T lymphocytes CTLs that may be cross-reactive against multiple HIV-1 stains Also to determine whether boosting with the vaccine orally or rectally will help induce mucosal antibody responses
Induction of CD8 CTL activity is considered a critical property for a candidate vaccine Additionally since the majority of HIV-1 infections occur after inoculation of a mucosal surface it is desirable to induce mucosal immunity as well as systemic immunity The HIV p17p24Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1
Induction of CD8 CTL activity is considered a critical property for a candidate vaccine Additionally since the majority of HIV-1 infections occur after inoculation of a mucosal surface it is desirable to induce mucosal immunity as well as systemic immunity The HIV p17p24Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1
Detailed Description:
Induction of CD8 CTL activity is considered a critical property for a candidate vaccine Additionally since the majority of HIV-1 infections occur after inoculation of a mucosal surface it is desirable to induce mucosal immunity as well as systemic immunity The HIV p17p24Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1
Volunteers receive HIV p17p24Ty-VLP vaccine or placebo by IM injection with or without alum adjuvant at months 0 2 and 6 and then either by mouth or rectal enema at months 10 and 11 Volunteers who receive oral vaccine boosting will receive concurrent omeprazole to decrease stomach acid
Volunteers receive HIV p17p24Ty-VLP vaccine or placebo by IM injection with or without alum adjuvant at months 0 2 and 6 and then either by mouth or rectal enema at months 10 and 11 Volunteers who receive oral vaccine boosting will receive concurrent omeprazole to decrease stomach acid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10569 | REGISTRY | DAIDS ES Registry Number | None |