Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617091
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
A Phase 1 Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine Administered to Healthy Adults Living Without and with HIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double Blinded Placebo Controlled Dose Ranging Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine Administered to Healthy Adults Living Without HIV and Living with HIV in Southern Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IAVI C114
Brief Summary:
A Phase 1 Randomized Double Blinded Placebo Controlled Dose Ranging Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine GRAdHIVNE1 Vaccine Administered to Healthy Adults Living without HIV and Living with HIV in Southern Africa
Detailed Description:
This is a Phase 1 trial for the GRAdHIVNE1 vaccine designed to evaluate safety tolerability and immunogenicity in healthy individuals PLWoH including healthy People Living with HIV PLWH This study builds on insights from prior T-cell vaccine trials and pre-clinical non-human primate studies which demonstrated that robust CD8 T cell responses are crucial for viral control but require broad polyfunctional responses that can also effectively counteract HIVs diversity and immune evasion strategies Inclusion of PLWoH and PLWH in this study is important for safety tolerability and immunogenicity data that can inform further development of the vaccine for prevention and therapeutic use Prior clinical trials using adenovirus vectors and exploring different vaccine approaches demonstrated safety and potential immunogenic benefits in PLWH despite not achieving sustained viral suppression post-treatment interruption Understanding these dynamics is key to evaluating the full therapeutic potential of vaccine induced immune responses in controlling HIV as well as inform the potential of the vaccine in aborting the establishment of a disseminated infection in the setting of prevention
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