HVTN 321: A phase 1 clinical trial to evaluate the safety and immunogenicity of the V3-region directed immunogens DV700P-RNA (prime) followed by DV701B1.1-RNA (boost) in adult participants without HIV
HIV Vaccine: HVTN 321 - Healthy Volunteers
Sponsor: National Institute of Allergy and Infectious Diseases
Enrolling: Male and Female Patients
Study Length: 16 Months
Clinic Visits: 12
IRB Number: AAAV7818
U.S. Govt. ID: NCT06919016
Contact: Brittany Rose: 347-770-2201 / br2731@cumc.columbia.edu
Additional Study Information: This trial is testing two experimental vaccines for HIV called DV700P-RNA and DV701B1.1-RNA. This trial is a Phase 1 study 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 approximately 16 months. You will be compensated for participating in this study.
Investigator
Magdalena Sobieszczyk, MD
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For more information, please contact:
Brittany Rose
br2731@cumc.columbia.edu
347-770-2201