NCT03547245

A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted

A Phase 1, Randomized, Double-blind, Placebo-controlled Dosage Escalation Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in HIV-uninfected, Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers.

Detailed description

This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers. The study is a randomized, double-blind, placebo-controlled dosage-escalation Phase 1 study intended to evaluate the safety and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in a prime-boost regimen.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
BIOLOGICAL	eOD-GT8 60mer + AS01B/ DPBS sucrose/IM	20 μg
BIOLOGICAL	eOD-GT8 60mer + AS01B/ DPBS sucrose/IM	100 μg
BIOLOGICAL	DPBS Sucrose	Placebo

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-01-17
• Completion: 2021-08-13
• First posted: 2018-06-06
• Last updated: 2022-05-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study