Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07390474
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • DV201P-RNA — BIOLOGICAL
    To be administered intramuscularly as a split dose.
  • DV202B1-RNA — BIOLOGICAL
    To be administered intramuscularly as a split dose.

Study Details

This is a phase 1, multicenter, open-label, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of DV201P-RNA and DV202B1-RNA, immunogens designed to induce HIV-1 envelope (Env) V2 apex-specific broadly neutralizing antibodies (V2 apex bnAbs). Both vaccines consist of a modified mRNA encapsulated in lipid nanoparticles (LNP) that when translated in cells produces HIV-1 Env gp150 transmembrane trimers. The trial will enroll adult volunteers without HIV and in overall good health.

Key Dates

Start date
Mar 25, 2026
Status verified
Jun 2026
Primary completion
Dec 14, 2027
Completion
Dec 14, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1: 50 mcg
    DV201P-RNA (50 mcg) at weeks 0 and 12. Followed by: DV202B1-RNA (50 mcg) at weeks 24 and 40.
  • Experimental: Group 2: 100 mcg
    DV201P-RNA (100 mcg) at weeks 0 and 12. Followed by: DV202B1-RNA (100 mcg) at weeks 24 and 40.
  • Experimental: Group 3: 150 mcg
    DV201P-RNA (150 mcg) at weeks 0 and 12. Followed by: DV202B1-RNA (150 mcg) at weeks 24 and 40.
  • Experimental: Group 4: TBD*
    DV202B1-RNA (50 mcg or 100 mcg or 150 mcg; highest dose that is determined to be safe and well tolerated from Groups 1-3) at weeks 0 and 12.

Primary Outcome Measure

Local reactogenicity for a minimum of 14 days following receipt of any study vaccine [ Time Frame: Day 0 (vaccination) through 14 days post-vaccination; at days 15, 99, 183, and 295 ]

Locations (7)

FacilityCityStateZIPSite coordinators
The Ponce de Leon Center CRSAtlantaGeorgia30308
Ericka Patrick
[email protected]
404-616-6313
The Hope Clinic of the Emory Vaccine Research Center; Emory UniversityDecaturGeorgia30030
Emily Osbourne
[email protected]
404-712-1370
Beth Israel Deaconess Medical Center VCRS (BIDMC VCRS Site # 32077)BostonMassachusetts02215
Audrey Nathanson
[email protected]
617-735-4463
Columbia P&S CRS (Site ID: 30329)New YorkNew York10032
Anyelina Cantos
[email protected]%0d
212-305-2201
University of Rochester Vaccines to Prevent HIV Infection CRSRochesterNew York14642
Michael O'Conner
[email protected]%0d
585-275-5744
Penn Prevention CRSPhiladelphiaPennsylvania19104
Debora Dunbar
[email protected]
215-746-3713
University of Pittsburgh CRSPittsburghPennsylvania15213
Stacey Edick
[email protected]
412-383-1748

Find similar trials in Atlanta, GA

By condition
HIV
By specialty
Infectious disease
By research site
The Ponce de Leon Center CRS· Atlanta, GAThe Hope Clinic of the Emory Vaccine Research Center; Emory University· Decatur, GABeth Israel Deaconess Medical Center VCRS· Boston, MAColumbia P&S CRS (Site ID: 30329)· New York, NYUniversity of Rochester Vaccines to Prevent HIV Infection CRS· Rochester, NYPenn Prevention CRS· Philadelphia, PA

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