A phase 1 clinical trial to evaluate the safety and immunogenicity of an HIV envelope trimer, N332-GT5 gp140, adjuvanted with SMNP in adult participants without HIV
HIV Vaccine: HVTN 144
Sponsor: NIH
Enrolling: Male and Female Patients
Study Length: 5 Months
Clinic Visits: 10
IRB Number: AAAU7912
U.S. Govt. ID: NCT06033209
Contact: Brittany Rose: 347-770-2201 / br2731@cumc.columbia.edu
Additional Study Information: The HIV Vaccine Trials Network (HVTN) and Columbia University Irving Medical Center (CUIMC) are conducting a study to learn about the safety and effectiveness of an experimental HIV vaccine. The study vaccine is a protein vaccine called N332-GT5 gp140. It includes a manmade protein that looks like a protein found on the outside of HIV. The study vaccine is given with an adjuvant called SMNP. Adjuvants are products that help alert the immune system to have a stronger response. Researchers hope that the immune system will respond by making antibodies and T-cells that could recognize and fight HIV if a person is ever exposed to the real virus in the future. You may be eligible for the study if you are between the ages of 18-55, in good physical health, not diagnosed with HIV, and determined not to be at a high risk of contracting HIV. The study consists of multiple groups, some of whom will receive 2 bolus doses (received all at once in a single injection) or 1 fractionated dose (received over multiple visits) and 1 bolus dose. If you join the study, you will either choose or be assigned a group, and will receive either 2 injections (if you are in the bolus dose only group) or 7 injections (if you are in the fractionated and bolus dose group). You will also attend additional follow-up visits to monitor your health during your participation in the study. Your total study participation will last about 4 months with 8-10 clinic visits if you are in a bolus dose group and about 4 months with 12-14 clinic visits if you are in a fractionated dose group. No matter which group you are in, we will contact you about 1 year after your last clinic visit to check on your health. You will be compensated for participating in this study, with total payment of a minimum of between $800 and $1,750, depending on which group you are part of in the study.
Investigator
Magdalena Sobieszczyk, MD
Do You Qualify?
Are you between the ages of 18 to 55? Yes No
Are you HIV-negative? Yes No
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For more information, please contact:
Brittany Rose
br2731@cumc.columbia.edu
347-770-2201