Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults
Eligible age
18–55 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This Phase 1 study will evaluate the safety, tolerability, and immune responses of investigational CH505 HIV vaccine regimens in adults in overall good health without HIV. Participants will receive CH505 protein nanoparticle vaccines (DV901-NP) formulated with the investigational adjuvant ACU-026-001-1, followed by either CH505 protein nanoparticle (DV902-NP) or CH505 mRNA vaccine boosters. The study will assess the ability of these regimens to induce HIV-specific immune responses, including B-cell responses associated with the development of broadly neutralizing antibodies. An immunology cohort will also evaluate how the location of booster vaccination affects immune responses.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
You may qualify if…
- ✓ 1. Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
- ✓ 2. At least 18 years old at screening and up to 55 years old on day of enrollment.
- ✓ 3. Available for clinic follow-up through the last clinic visit and willing to be contacted 12 months after the last study product administration of ACU-026-001-1.
- ✓ 4. Willing to undergo study procedures as outlined in the schedule of procedures.
- ✓ 5. Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals are required prior to enrollment into HVTN 324.
- ✓ 6. In good general health according to the clinical judgment of the site investigator.
- ✓ 7. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgment of the site investigator.
- ✓ 8. Agrees to discuss their potential for HIV acquisition and agrees to HIV prevention counseling.
You may not qualify if…
- ✕ 1. Woman who is breastfeeding or pregnant.
- ✕ 2. Body mass index (BMI) ≥40. Enrollment of individuals with BMI ≥40 who are in good health, as assessed by the site investigator, may be considered by approval.
- ✕ 3. Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with type 2 DM that is well controlled on hypoglycemic agent(s) may be considered on a case-by-case basis, provided that the HgbA1c is ≤8% within the last 6 months (sites may draw these at screening).
- ✕ 4. Previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
- ✕ 5. Receipt of non-HIV investigational vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) Emergency Use Listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.
- ✕ 6. Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as glucocorticoid use or prednisone dose of ≥10 mg/day, within 3 months prior to enrollment.
- ✕ 7. Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires approval.
- ✕ 8. Receipt of any of the following within 4 weeks prior to enrollment:
Where it's recruiting
San Francisco
Atlanta
Boston
Rochester
Philadelphia · Pittsburgh
Nashville
Source: ClinicalTrials.gov · NCT07757802 · last updated 2026-10-23