HVTN 322: A phase 1 clinical trial to evaluate the safety and immunogenicity of the V2 apex-directed immunogens DV201P-RNA and DV202B1-RNA in adult participants without HIV
| Sponsor: |
National Institute of Allergy and Infectious Diseases |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
ACYY1174 |
| U.S. Govt. ID: |
NCT07390474 |
| Contact: |
Columbia Research Unit Screening Team: 347-770-2201 / hiv_studies@cumc.columbia.edu |
This is a Phase 1 trial testing two experimental vaccines for HIV called DV201P-RNA and DV202B1-RNA. This study is testing whether these vaccines are safe to use in people and can be taken comfortably, as well as how the immune system responds to the vaccines. Both vaccines are made using messenger ribonucleic acid (mRNA) technology. mRNA is a piece of genetic code carried into your body by the vaccine as a message with instructions. It works in the same way that the mRNA vaccines against COVID instruct the body's cells to make the SARS-CoV-2 spike protein. Instead of showing your immune system actual pieces of HIV, the vaccine carries instructions that show some cells how to make small pieces that look like parts of HIV. You may be eligible for this study if are between the ages of 18 and 55, do not have HIV, and are healthy. You may not be eligible for this study if you are pregnant or breastfeeding, have previously received an HIV vaccine, or have certain medical conditions. If you participate in this study, you will attend clinic visits to have your blood drawn, receive injections of the experimental HIV vaccines, have white blood cells collected through a process called leukapheresis, and have cells from your lymph nodes collected using a thin needle guided by ultrasound. Your participation in the study will last either about 4 or 16 months, depending on which group you are in. You will be compensated for participating in this study, a minimum of $975, for completing all required study procedures.
Investigator
Magdalena Sobieszczyk, MD
| Are you between the ages of 18 and 55? |
Yes |
No |
| Do you have HIV? |
Yes |
No |
| Are you comfortable having your blood drawn? |
Yes |
No |
| Are you available to visit our clinic during regular business hours (9 AM to 5 PM, Mon to Fri)? |
Yes |
No |