Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02756208
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2016-04-17
Brief Title:
A Safety and Immunogenicity Trial of IHV01
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase I Safety and Immunogenicity Trial of IHV01 in HIV-1 Uninfected Volunteers
Status:
COMPLETED
Status Verified Date:
2021-11
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:
FLSC-001
Brief Summary:
This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized placebo-controlled modified double-blinded dose escalation study in 60 healthy adult volunteers Human Immunodeficiency Virus-1 uninfected
Detailed Description:
This is a Phase 1 randomized placebo-controlled modified double-blinded dose escalation study in 60 healthy adult volunteers who are Human Immunodeficiency Virus-1 HIV-1 uninfected Participants in the study will receive 4 injections at 0 4 8 and 24 weeks and will be followed for an additional 24 weeks The total study duration will be 48 weeks As this is a Phase 1 trial the primary objective is to document safety of the Full Length Single Chain FLSC gp120-CD4 complex vaccine with a secondary objective to evaluate immune responses induced by the vaccine This vaccine is being evaluated as it is constructed so that the gp120 and CD4 moieties form a stable intra-chain binding interaction that forms a transition state structure that presents conserved conformational domains involved in the early HIV replication process It is hypothesized that antibodies directed to these epitopes would be highly cross-reactive and potentially useful for HIV vaccine development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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