Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults

Status Completed

Clinical Trial Summary

This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).

Clinical Trial Description

Subjects will receive a total of two doses administered IM on Days 0 and 56. Subjects will be monitored for approximately 421 days (one year following the last study injection), including safety laboratory analyses done just prior to and 7 days following each study injection. Tears and nasal swabs will be obtained for exploratory antibody analysis at Days 0, 70, and 224. Blood samples will be obtained for immunological assays (secondary and exploratory) at Days 0, 7, 14, 56, 63, 70, 84, and 224). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03722472
Study type	Interventional
Source	Access to Advanced Health Institute (AAHI)
Contact
Status	Completed
Phase	Phase 1
Start date	October 2, 2018
Completion date	June 15, 2020

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