NCT01868464

Challenge Model for Assessment of Human TB Immunity

Completed Phase 1 Last updated 27 January 2020

What this trial tests

Phase 1 trial testing BCG TICE strain in Tuberculosis in 92 participants. Completed in 18 December 2017.

Timeline

28 May 2014

Primary endpoint
18 December 2017

18 December 2017

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	92
Start date	28 May 2014
Primary completion	18 December 2017
Estimated completion	18 December 2017
Sites	2 locations across United States

Drugs / interventions tested

• BCG TICE strain — full drug profile →

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I open-label, dose escalation trial to evaluate the use of Tice® BCG as a challenge for future assessment of in vivo TB immunity. Subjects will be recruited from the target population reflecting the community at 2 VTEU sites. Enrollment will occur over 14 months. Subjects who provide informed consent will be screened, and up to 120 eligible, HIV and TB uninfected subjects, 18-45 years, inclusive, will be enrolled for study interventions and sequentially assigned to 1 of 4 dose groups. Doses of Tice BCG from 2 to 16x10\^6 cfu will be delivered ID in a dose escalation format to 4 groups of 30 subjects per dose group. Primary Objectives: 1) Evaluate the safety of different doses of ID Tice BCG for use as a human challenge model for TB infection. 2) Examine shedding from ID challenge sites after administration of different doses of Tice BCG in TB naive healthy subjects. 3) Evaluate the reproducibility of BCG shedding over time with both quantitative PCR and culture.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Phase 1 Open-Label Dose Escalation Trial for the Development of a Human Bacillus Calmette-Guérin Challenge Model for Assessment of Tuberculosis Immunity In Vivo.
   Blazevic A, Edwards RL, Xia M, Eickhoff CS, et al · · 2024 · cited 8× · PMID 38019956 · DOI 10.1093/infdis/jiad441