A Phase 1 clinical trial to evaluate the safety and immunogenicity of Glycan TrimmedHIV-1 nanoparticle Vaccine (UVAX-1107) followed by, Wild Type, HIV-1 nanoparticle Vaccine (UVAX-1197) boost both adjuvanted with 3M-052-AF + Alum in adult participants without HIV
HIV Vaccine Study: HVTN 319
Sponsor: National Institute of Allergy and Infectious Diseases
Enrolling: Male and Female Patients
Study Length: 11 Months
Clinic Visits: 12
IRB Number: AAAV7489
U.S. Govt. ID: NCT06905275
Contact: Brittany Rose: 347-770-2201 / br2731@cumc.columbia.edu
Additional Study Information: The HIV Vaccine Trials Network, Division of AIDS, and Columbia University Irving Medical Center are conducting a trial to learn about the safety and effectiveness of two new experimental HIV vaccines. This is a first-in-human phase 1 clinical trial that will be testing 2 study vaccines, UVAX-1107 and UVAX-1197. The goal is to understand if the study products are safe to use in people not living with HIV, and whether they can get the study products without being too uncomfortable. We also want to understand how people's immune systems respond to the study products at different dosages, and whether people develop a certain type of cell in their lymph nodes that researchers think is important for protecting against HIV. There will be 3 groups in this study. The first group will receive both study products at a lower dosage, while the second group will receive both study products at a higher dosage. The third group will only receive one type of study product throughout the study. Any time you receive an injection of the study product, you will receive an additional injection of an adjuvant, which helps the immune system respond better to a drug or vaccine. In total, you will receive 2 injections at each of the 4 vaccination visits, which means there are 8 injections in total. These 4 vaccination visits will occur across the span of 8 months. If you are aged 18-55, in overall good health and not living with HIV, you may be able to participate. Your participation in this study will be for about 11 months. Study procedures will include blood draws, injections, leukapheresis (a procedure to collect white blood cells), and a lymph node biopsy. Because the vaccines have not been given to people before, we do not know what all the risks may be. Common side effects from all vaccines include headache, fever, chills, rash, aches and pains, nausea, dizziness, and fatigue (feeling tired). You will receive a minimum total compensation amount of $1600 for completing all visits.
Investigator
Magdalena Sobieszczyk, MD
Do You Qualify?
Are you HIV negative? Yes No
Are you between the ages of 18-55? Yes No
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For more information, please contact:
Brittany Rose
br2731@cumc.columbia.edu
347-770-2201