HIV Vaccines for HIV/AIDS
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed.
Are You a Good Fit for This Trial?
This trial is for adults without HIV who are in good health. Participants will be part of a study testing two experimental HIV vaccines combined with different adjuvants to boost immune response. The trial excludes individuals under certain medications, those with immune system issues, or anyone with conditions that might interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive 60 mcg of CD4BS CH505M5 Pr-NP1 administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
Treatment Part B
Participants receive 60 mcg of CD4BS CH505M5 Pr-NP1 with adjuvant, followed by 300 mcg of CH505TF chTrimer with adjuvant at months 6 and 8
Treatment Part C
Participants receive 100 mcg of CD4BS CH505M5 Pr-NP1 with adjuvant, followed by 300 mcg of CH505TF chTrimer with adjuvant at months 6 and 8
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CD4BS CH505M5 Pr-NP1
- CH505TF chTrimer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Duke University
Collaborator
Access to Advanced Health Institute (AAHI)
Collaborator
Department of Health and Human Services
Collaborator