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

HIV-1-infection Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05414786
Study type Interventional
Source International AIDS Vaccine Initiative
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 25, 2022
Completion date June 30, 2023
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