HIV Vaccines for HIV/AIDS
Recruiting at 5 trial locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Stay on Your Current Meds
No Placebo Group
Trial Summary
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.
Eligibility Criteria
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
ALT levels below specified threshold
Platelet count within specified range
Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity
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Exclusion Criteria
Breastfeeding or pregnant
Receipt of non-HIV experimental vaccine(s) within the last 1 year
My asthma meets specific health criteria.
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Treatment Details
Interventions
- CD4BS CH505M5 Pr-NP1 (Virus Therapy)
- CH505TF chTrimer (Virus Therapy)
Trial OverviewThe clinical trial is evaluating the safety and effectiveness of two HIV vaccine candidates: CD4BS CH505M5 Pr-NP1 and CH505 TF chTrimer. These are given alongside adjuvants—either Lipid Nanoparticles (LNPs) or 3M-052-AF plus Alum—to enhance immunity.
Participant Groups
7Treatment groups
Experimental Treatment
Group I: Part C - Group 7Experimental Treatment4 Interventions
* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.
Group II: Part C - Group 6Experimental Treatment4 Interventions
* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4,
* Followed by 300 mcg of CH505TF chTrimer, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.
Group III: Part C - Group 5Experimental Treatment3 Interventions
Low dose:
* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4,
* Followed by 300 mcg of CH505TF chTrimer, admixed with 1mg empty LNP adjuvant to be administered at months 6 and 8.
OR,
High Dose:
* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-01 adjuvant to be administered as two 0.5 mL doses intramuscularly at month 0, 2, and 4,
* Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.
Group IV: Part B - Group 4Experimental Treatment4 Interventions
* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.
Group V: Part B - Group 3Experimental Treatment3 Interventions
* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.
Group VI: Part B - Group 2Experimental Treatment3 Interventions
* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 1.0 mcg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.
Group VII: Part A - Group 1Experimental Treatment1 Intervention
• 60 mcg of CD4BS CH505M5 Pr-NP1, to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Trials
3,361
Recruited
5,516,000+
National Institutes of Health (NIH)
Collaborator
Trials
2,896
Recruited
8,053,000+
Duke University
Collaborator
Trials
2,495
Recruited
5,912,000+
Access to Advanced Health Institute (AAHI)
Collaborator
Trials
30
Recruited
1,700+
Department of Health and Human Services
Collaborator
Trials
240
Recruited
944,000+