NCT05414786

A Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644)

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health.

Detailed description

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health. The hypothesis is that eOD-GT8 60mer mRNA Vaccine as a "germline-targeting" immunogen will generate detectable VRC01-class IgG B-cells in African populations. Eighteen participants. An over-enrollment of up to 2 participants will be permitted to facilitate rapid enrollment. Participants who leave the study for any reason will not be replaced. Adults ≥18 and ≤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. Administration of eOD-GT8 60mer mRNA Vaccine (100µg) will occur on Week 0 and Week 8. There is no blinding and no randomization in this open-label study. Participants will be screened up to 56 days before the first IP administration and will be actively followed for 6 months after the last IP administration. The total study duration including screening and enrollment is approximately 13 months. A participant is expected to be in the study for 10 months from screening to last study visit. The study is expected to screen and enroll over 3 months.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
BIOLOGICAL	eOD-GT8 60mer mRNA Vaccine (100µg)	* 2 doses eOD-GT8 60mer mRNA Vaccine (100µg), 2 vaccinations, 8 weeks apart * No control group. There is no blinding and no randomization in this open label study

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-06-10
• Last updated: 2023-03-10

Locations

2 sites across 2 countries: Rwanda, South Africa

Regulatory

• FDA-regulated drug study