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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Investigational vaccine composed of Trimer 4571 100mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent
Volume matched control for Trimer 4571 vaccine 100mcg
Investigational vaccine composed of Trimer 4571 500mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent
Volume matched control for Trimer 4571 vaccine 500mcg
AIDS Clinical Trials Unit/The Ohio State University
Columbus, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Safety and tolerability of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART
The proportion of participants experiencing at least one Grade 3 or higher adverse event will be summarized within and across the Trimer 4571 vaccine 100mcg, Trimer 4571 vaccine 500mcg and placebo control vaccine groups. The number of adverse events in each group will also be summarized by severity, body system, and relationship to study vaccine using frequencies, percent, and 95% confidence intervals.
Time frame: Day 0 through Week 44
Immunogenicity of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART
Comparison of the change in the serum ID50 neutralization titer of BG505.W6M.C2 virus between Trimer 4571 vaccine 100mcg, Trimer 4571 vaccine 500mcg, and placebo control vaccine. Vaccine responders will be as defined by either (i) 4-fold increase in neutralization titer from pre-vaccination to at least one virus in the curated virus panel at any protocol-specified time point post vaccination and/or (ii) Evidence of BG505.W2 neutralization at any protocol-specified time point post vaccination.
Time frame: Baseline and Week 22
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