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
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 |
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
Are you between the ages of 18 to 55? |
Yes |
No |
Are you HIV-negative? |
Yes |
No |