NCT06449196

Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV (PLWH) in Africa

An Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV PLWH) in Africa, Randomized for Assessment of Fractional Doses

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

An Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living with HIV (PLWH) in Africa, Randomized for Assessment of Fractional Doses.

Detailed description

The study will enroll people living with HIV, 18-50 years of age on a stable antiretroviral therapy regimen; principal exclusion criteria include history of AIDS-defining illness, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)	HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via bolus dosing.
DRUG	: Investigational product HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM)	HIV Env Mosaic immunogens MOS1SIP, MOS2SIP, M3SIP8 and Monophosphoryl lipid A liposomes (MPLA-5) adjuvant (IM) administered via fractionated dosing

Timeline

• Start date: 2024-08-27
• Primary completion: 2025-02-04
• Completion: 2025-02-04
• First posted: 2024-06-07
• Last updated: 2025-03-14