Trials / Active Not Recruiting

Active Not RecruitingNCT05001373

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 56 (estimated)

Sponsor: International AIDS Vaccine Initiative · Network
Sex: All
Age: 18 Years – 50 Years
Healthy volunteers: Accepted

Summary

Detailed description

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health. The hypothesis is that sequential vaccination by a germline-targeting prime followed by directional boost immunogens can induce specific classes of B-cell responses and guide their early maturation toward broadly neutralizing antibody (bnAb) development through an mRNA platform. Fifty-six participants. Adults 18 to 50 years of age who meet all protocol inclusion criteria, who do not meet any protocol exclusion criteria, who understand the study (as demonstrated by the Assessment of \[Informed Consent\] Understanding \[AOU\]), and who can provide written informed consent. Randomization allocation is 16:16:16:8 for Groups 1-4 respectively. There is no blinding in this study. Site and study staff will not be blinded to the IP.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	Core-g28v2 60mer mRNA Vaccine	100µg, Intramuscularly
BIOLOGICAL	eOD-GT8 60mer mRNA Vaccine	100µg, Intramuscularly

Timeline

Start date: 2021-11-12
Primary completion: 2023-06-20
Completion: 2024-07-01
First posted: 2021-08-11
Last updated: 2024-05-01

Locations

4 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05001373. Inclusion in this directory is not an endorsement.