A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07569029
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • DV700P-RNA 100 mcg — BIOLOGICAL
    Intramuscular injection
  • DV701B1.1-RNA 100 mcg — BIOLOGICAL
    Intramuscular injection

Study Details

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.

Key Dates

Start date
Jun 2, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1
    Participants will receive: * Week 0: DV700P-RNA * Week 8: DV700P-RNA * Week 16: DV701B1.1-RNA
  • Experimental: Group 2
    Participants will receive: * Week 0: DV700P-RNA * Week 8: DV701B1.1-RNA

Primary Outcome Measure

Local reactogenicity following study product administration [ Time Frame: 14 days following each vaccination ]

Locations (4)

FacilityCityStateZIPSite coordinators
Alabama CRS (Site ID: 31788)BirminghamAlabama35222
Heather Logan
[email protected]
205-873-8686
The Ponce de Leon Center CRS (Site ID: 5802)AtlantaGeorgia30308
Ericka Patrick
[email protected]
404-616-6313
Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077)BostonMassachusetts02115
Jose Licona
[email protected]
617-525-9433
Seattle Vaccine and Prevention CRS (Site ID: 30331)SeattleWashington98109
Jennifer Han
[email protected]

Find similar trials in Birmingham, AL

By condition
HIV
By specialty
Infectious disease
By research site
Alabama CRS (Site ID: 31788)· Birmingham, ALThe Ponce de Leon Center CRS (Site ID: 5802)· Atlanta, GABeth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077)· Boston, MASeattle Vaccine and Prevention CRS (Site ID: 30331)· Seattle, WA

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