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

NCT03547245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-05-12

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

eOD-GT8 60mer + AS01B/ DPBS sucrose/IM

20 μg

BIOLOGICAL

eOD-GT8 60mer + AS01B/ DPBS sucrose/IM

100 μg

BIOLOGICAL

DPBS Sucrose

Placebo

Sponsors & Collaborators

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • David Diemert, MD, FRCP(C) · George Washington University School of Medicine & Health Sciences

  • Julie McElrath, MD, PhD · Seattle HIV Vaccine Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2020-01-17
Completion
2021-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547245 on ClinicalTrials.gov