Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults (NCT07757802) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults
United States54 participantsStarted 2026-09-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
. At least 18 years old at screening and up to 55 years old on day of enrollment.
. 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.
. Willing to undergo study procedures as outlined in the schedule of procedures.
. 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.
. In good general health according to the clinical judgment of the site investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of solicited local reactogenicity
Timeframe: Through 14 days after each study vaccination
2
Incidence of solicited systemic reactogenicity
Timeframe: Through 14 days after each study vaccination
3
Incidence of adverse events
Timeframe: Through 30 days after each study vaccination
4
Incidence of serious adverse events
Timeframe: Through 52 weeks after the last study vaccination
5
Incidence of medically attended adverse events
Timeframe: Through 52 weeks after the last study vaccination
6
Incidence of adverse events of special interest
Timeframe: Through 52 weeks after the last study vaccination
7
Incidence of adverse events leading to permanent discontinuation of study product or participant withdrawal
Timeframe: Through 52 weeks after the last study vaccination
Trial details
NCT IDNCT07757802
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.
. Agrees to discuss their potential for HIV acquisition and agrees to HIV prevention counseling.
Exclusion criteria
1. Platelet count of 125,000 to 550,000/mm3.
2. Alanine aminotransferase (ALT) \<2.5× the upper limit of institutional reference range.
3. Serum creatinine ≤1.1× the upper limit of normal (ULN) based on the institutional normal range.
4. Total measured serum calcium level \>8.5 mg/dL (if the participant consented to have leukapheresis as a study procedure).
5. Systolic blood pressure of 90 to \<140 mm Hg and diastolic blood pressure of 50 to \<90 mm Hg at screening visit. The average blood pressure between the screening visit and the enrollment visit must be below 140 mm Hg systolic and 90 mmHg diastolic. A single measurement of ≥160 mm Hg systolic or ≥100 mm Hg diastolic during the current study evaluation is exclusionary.
6. Negative HIV test results by one of the following options:
7. Negative for anti-hepatitis C virus (HCV) antibodies (Abs) or negative HCV nucleic acid test (NAT) if anti-HCV Abs are detected.
8. Negative for hepatitis B surface antigen (Ag).
8
Frequency of CH505M5.G458Y/GnT1neg-specific IgG+ memory B cells
Timeframe: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
9
Response rate of precursor-specific serum neutralizing antibodies
Timeframe: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)
10
Magnitude of precursor-specific serum neutralizing antibodies
Timeframe: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)