NCT05604209

Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART

IGHID 12107 - A Phase I Study to Evaluate the Safety and Immunogenicity of the ChAdOx1.HIVconsv62 - MVA.tHIVconsv4 (C62-M4) or, ChAdOx1.tHIVconsv1+C62 - MVA.tHIVconsv3+M4 (C1C62-M3M4) Prime-Boost Regimens in Persons With HIV-1 Suppressed on Antiretroviral Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a double blind, randomized, placebo-controlled, parallel design study in which 18 in participants with HIV (PWH) on suppressive antiretroviral therapy will be randomly assigned to receive vaccination with C62 followed by M4 (C62-M4), C62 and C1 followed by M4 and M3 (C1C62-M3M4), or placebo. The purpose of this study is to find out: * If it is safe for people to receive intramuscular (IM) vaccination with C62-M4 or C1C62-M3M4 * If giving participants these vaccine doses will improve their immune system response to help the body get rid of HIV in the cells

Detailed description

This is a Phase 1, double blind, randomized to evaluate safety and immunogenicity of investigational vaccines given in a sequential regimen. Participants will be screened for eligibility and have a enrollment visit with leukapheresis (white blood cell collection procedure). After determination of eligibility, participants will be randomized on Day 0 to C62-M4, C1C62-M3M4, or placebo arms in a 8:8:2 ratio. C62, C1C62, or placebo will be given as an intramuscular (IM) injection on Day 0. M4, M3M4, or placebo will be given as an IM injection on Day 28. Post-treatment leukapheresis will be completed at Day 56. Each enrolled participant will complete 12 clinic study visits and 5 phone study visits over the course of approximately 36 weeks (9 months).

Conditions

• HIV Vaccine
• HIV-1-infection

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1.HIVconsv62	Administered intramuscularly (IM) at Day 0
BIOLOGICAL	ChAdOx1.tHIVconsv1	Administered intramuscularly (IM) at Day 0
BIOLOGICAL	MVA.tHIVconsv4	Administered intramuscularly (IM) at Day 28
BIOLOGICAL	MVA.tHIVconsv3	Administered intramuscularly (IM) at Day 28
OTHER	Placebo	Administered at intramuscularly (IM) Day 0 and Day 28

Timeline

• Start date: 2022-10-13
• Primary completion: 2024-09-12
• Completion: 2025-01-10
• First posted: 2022-11-03
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study