Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT04985760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
Sponsor:
Madhu Chhanda Choudhary
Organization:
Study Overview
Official Title:
Safety, Tolerability and Immunogenicity of Recombinant HIV Envelope Protein VRC-HIVRGP096-00-VP (Trimer 4571) Vaccine, in HIV-1 Infected Adults on Suppressive ART
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
NETI
Brief Summary:
Trimer 4571 is a vaccine designed to stimulate the development of broadly neutralizing antibodies (bnAbs) against HIV. Trimer 4571 is investigational, meaning it is not approved by the US Food and Drug Administration (FDA). There is limited human experience with the Trimer 4571 vaccine administered with aluminum hydroxide (alum) and the vaccine has not been tested in people with HIV prior to this study although it has been tested in healthy volunteers. The goal of this study is to see if Trimer 4571 is safe and well tolerated and to see if it will help the immune system produce bnAbs against HIV.
Detailed Description:
The immune system is composed of special cells, proteins, tissues, and organs that protect against germs and microorganisms and is the body's defense against infections. Antibodies are a type of protein that helps the body fight infection and are usually made by a person's own immune system. A type of antibody that can recognize and block many types of HIV from entering healthy cells are called broadly neutralizing antibodies, or 'bnAbs', and may also activate other immune cells to help destroy HIV-infected cells. Research has shown that people with HIV who develop bnAbs against the virus are better able to control the infection. While the immune systems of some people with HIV show signs of early bnAb production, only a small percentage of people with HIV naturally develop bnAbs.
Approximately 32 participants will be sequentially enrolled and randomized 3:1 by chance like rolling dice to receive either the Trimer 4571 vaccine or a placebo vaccine that does not contain Trimer 4571.
Participants will be asked to attend 11 study visits over a period of approximately 50 weeks and receive 3 doses of their assigned study vaccine: one at Entry, one at Week 8 and one at Week 20. Researchers will compare the results from participants who get the Trimer 4571 vaccine with results from participants who get the placebo vaccine. Participants, the researchers and the clinic staff will not know which vaccine participants are getting.
After Week 20, participants will be followed for 24 additional weeks with study visits and tests to monitor their health and safety and to see how the study vaccine affects the immune system and the virus.
Approximately 32 participants will be sequentially enrolled and randomized 3:1 by chance like rolling dice to receive either the Trimer 4571 vaccine or a placebo vaccine that does not contain Trimer 4571.
Participants will be asked to attend 11 study visits over a period of approximately 50 weeks and receive 3 doses of their assigned study vaccine: one at Entry, one at Week 8 and one at Week 20. Researchers will compare the results from participants who get the Trimer 4571 vaccine with results from participants who get the placebo vaccine. Participants, the researchers and the clinic staff will not know which vaccine participants are getting.
After Week 20, participants will be followed for 24 additional weeks with study visits and tests to monitor their health and safety and to see how the study vaccine affects the immune system and the virus.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01AI152969 | NIH | None | https://reporter.nih.gov/quic… | View |