NCT03722472

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

A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Access to Advanced Health Institute (AAHI) · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Pulmonary TB

Interventions

Type	Name	Description
BIOLOGICAL	ID93 + GLA-SE	The single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE.

Timeline

• Start date: 2018-10-02
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2018-10-29
• Last updated: 2023-06-01
• Results posted: 2023-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study