DV700P-RNA + DV701B1.1-RNA for HIV

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)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.

Research Team

Eligibility Criteria

This trial is for healthy adults aged 18 to 55 without HIV. Participants will be involved in the study for approximately 16 months, attending around 12 visits involving blood draws, injections, and cell collection from lymph nodes.

Inclusion Criteria

Can attend all clinic visits until the end of the study

My hemoglobin level is at least 11.0 g/dL if female, or 13.0 g/dL if male.

Women of pregnancy potential must agree not to seek pregnancy through methods like IVF from 21 days before joining the study until 8 weeks after the last vaccination

Exclusion Criteria

My BMI is 40 or higher, but I am in good health.

I have not received blood products or immunoglobulin in the last 16 weeks.

Received other vaccines within 14 days before enrollment

Treatment Details

Interventions

• DV700P-RNA (Cancer Vaccine)
• DV701B1.1-RNA (Cancer Vaccine)

Trial Overview The trial is testing two new vaccines: DV700P-RNA and DV701B1.1-RNA. It's a phase 1 study to assess safety, comfort level with administration, and immune response in humans for the first time.

Participant Groups

Group I: Group 3 Experimental Treatment 2 Interventions

DV700P-RNA: 150 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 150 mcg at week 40

Group II: Group 2 Experimental Treatment 2 Interventions

DV700P-RNA: 100 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 100 mcg at week 40

Group III: Group 1 Experimental Treatment 2 Interventions

DV700P-RNA: 50 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 50 mcg at week 40

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Dr. Georges C. Benjamin

Department of Health and Human Services

Chief Medical Officer

MD from Harvard Medical School

Robert F. Kennedy Jr.

Department of Health and Human Services

Chief Executive Officer

JD from University of Virginia School of Law

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University