mRNA Vaccines for HIV

Not yet recruiting at 8 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: Antiretrovirals

Must not be taking: NNRTIs, Long-acting ART

Disqualifiers: Advanced HIV, Cancer, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Agrees not to participate in another investigational study during participation unless approved.

* Able and willing to provide informed consent.

* Lowest (nadir) CD4+ count between 250 and 450 cells/mm³.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DV700P-RNA and DV701B1.1-RNA immunizations at specified intervals

16 weeks

3 visits (in-person)

Analytical Treatment Interruption (ATI)

Participants undergo a planned pause in antiretroviral therapy to assess immune response

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment and ART restart

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DV700P-RNA
• DV701B1.1-RNA

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 2 Interventions

Participants will receive: * Week 0: DV700P-RNA * Week 8: DV701B1.1-RNA

Group II: Group 1 Experimental Treatment 2 Interventions

Participants will receive: * Week 0: DV700P-RNA * Week 8: DV700P-RNA * Week 16: DV701B1.1-RNA

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Department of Health and Human Services (HHS)

Collaborator

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+