NCT03265977

A Phase II Study of H56:IC31 in Healthy Adolescents

A Randomized, Placebo Controlled, Double-Blind Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection With Mycobacterium Tuberculosis (Mtb) of H56:IC31 in Healthy Adolescents

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents.

Detailed description

This clinical trial will evaluate safety, immunogenicity, and prevention of Mtb infection, (measured by IGRA conversion) of H56:IC31 in remotely BCG vaccinated adolescents. A TB vaccination strategy incorporating H56:IC31 in adolescents or young adults, if found to prevent Mtb infection, would likely have a major impact on TB disease, TB transmission, and control of the epidemic. If vaccination with H56:IC31 is shown to prevent infection with Mtb in this proof of concept study in adolescents, additional larger scale studies examining the impact on TB disease in more diverse populations would be warranted. Primary objectives * To evaluate the safety profile of H56:IC31 compared to placebo in HIV-uninfected, remotely BCG vaccinated adolescents. * To evaluate prevention of Mtb infection by H56:IC31 compared to placebo, as measured by rates of conversion using an ESAT-6 free IGRA. Secondary objectives * To evaluate prevention of Mtb infection by H56:IC31 compared to placebo, as measured by rates of sustained conversion using an ESAT-6 free IGRA. * To evaluate trends in ESAT-6 free IGRA prolonged/sustained conversions and late reversions (i.e., through more than 6 months post initial conversion) in ESAT-6 free IGRA converters. * To investigate the immunogenicity of H56:IC31 in HIV-uninfected, remotely BCG vaccinated adolescents.

Conditions

• Tuberculosis Infection

Interventions

Type	Name	Description
BIOLOGICAL	H56:IC31	The H56 antigen is a fusion protein created from 3 Mtb antigens: antigen 85B (Ag85B), ESAT-6, and Rv2660c.
OTHER	Placebo	Normal saline

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-04-30
• Completion: 2021-06-30
• First posted: 2017-08-29
• Last updated: 2018-04-10

Locations

4 sites across 2 countries: South Africa, Tanzania