HVTN 302: A phase 1, randomized, open-label clinical trial to evaluate the safety andimmunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151CD4KO HIV trimer mRNA vaccines in healthy, HIV-uninfected adult participants
HVTN 302: HIV Vaccine Trial for Healthy, HIV Negative Adults, Ages 18-55
Sponsor: NIH
Enrolling: Male and Female Patients
Study Length: 1 Years
Clinic Visits: 12
IRB Number: AAAT8516
U.S. Govt. ID: NCT05217641
Contact: Clinical Research Team: 347-770-2201 / jb2226@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 3 experimental HIV vaccines. This is a first-in-human phase 1 clinical trial of experimental HIV vaccines utilizing the mRNA vaccine platform. The 3 different experimental vaccines being tested are made using messenger ribonucleic acid (mRNA) technology developed by Moderna, Inc. mRNA is a piece of genetic code carried into your body by the vaccine as a message with instructions 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 study vaccines carry instructions that show human muscle cells how to make small pieces that look like parts of HIV. Researchers hope that the immune system will respond by making antibodies and T-cells that could 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 in good physical health and are determined not to be at a high risk of contracting HIV. If you join the study, you will receive 3 injections over the course of about 6 months. You will also attend additional follow-up visits to monitor your health during your participation. Procedures during your participation would include injections of the experimental HIV vaccines, physical exams and vital signs, collection of blood and urine for routine laboratory tests (including pregnancy tests if you can get pregnant), HIV testing and collection of blood samples to look at your immune responses to the vaccine. A total of 108 people may participate in this study. The information gained from this trial will help us determine if these vaccines are safe and effective in people and contribute to research on the development of future HIV vaccines. You will be paid a minimum of $825 for completing all required study procedures.
This study is closed
Magdalena Sobieszczyk, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Are you HIV negative? Yes No
You may be eligible for this study

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For more information, please contact:
Clinical Research Team