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A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Glycan-trimmed HIV-1 Nanoparticle Vaccine (UVAX-1107), Followed by Homologous or Wild-type HIV-1 Nanoparticle Vaccine (UVAX-1197) Boost, Each Adjuvanted With 3M-052-AF + Alum in Adult Participants Without HIV
This is a phase 1, first-in-human (FIH) trial for the combination of UVAX-1107 and UVAX-1197, both adjuvanted with 3M-052-AF + Aluminum Hydroxide Suspension (Alum). This means it is the first time this combination of study products is being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Twenty-five volunteers without HIV and in overall good health will be enrolled and be in this study for a little over 1 year (56 weeks) of clinic visits (about 12 visits), with a follow-up contact 1 year after the final injection to check on their health. Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Alabama CRS (#31788)
Birmingham, Alabama, United States
Columbia P&S CRS (#30329)
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Vanderbilt Vaccine (VV) CRS (#30352)
Nashville, Tennessee, United States
Start Date
July 7, 2025
Primary Completion Date
July 20, 2027
Completion Date
July 20, 2027
Last Updated
September 4, 2025
25
ESTIMATED participants
3M-052-AF + Alum
BIOLOGICAL
UVAX-1107
BIOLOGICAL
UVAX-1197
BIOLOGICAL
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05668026