NCT00396370 is a Phase 1 clinical trial of BCG strain Connaught in Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT00396370?

NCT00396370 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT00396370?

Interventions in NCT00396370: BCG strain Connaught, BCG strain Danish, BCG strain Danish, Placebo, Placebo.

What condition does NCT00396370 study?

NCT00396370 studies Tuberculosis.

Is NCT00396370 still recruiting?

NCT00396370 is currently completed. Last updated 12 November 2019.

Last reviewed 2019-11-12 · How we verify

NCT00396370

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BCG Vaccination Delivered Intradermally, Orally and by Combined Routes

Completed Phase 1 Last updated 12 November 2019

What this trial tests

Phase 1 trial testing BCG strain Connaught in Tuberculosis in 69 participants. Completed in 23 July 2012.

Timeline

2 December 2008

Primary endpoint
23 July 2012

23 July 2012

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	69
Start date	2 December 2008
Primary completion	23 July 2012
Estimated completion	23 July 2012
Sites	1 location across United States

Drugs / interventions tested

BCG strain Connaught — full drug profile →
BCG strain Danish — full drug profile →
BCG strain Danish — full drug profile →
Placebo
Placebo

Conditions studied

Tuberculosis — all drugs for Tuberculosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 40, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both methods produces greater results. BCG vaccine and/or placebo (substance containing no medication) will be given by mouth and/or by injection into the skin. This study, conducted at Saint Louis University, will enroll 60 (up to 80) healthy volunteers, 18-40 years old, who are negative for a TB test (QuantiFERON®-Gold) and human immunodeficiency virus (HIV). Study procedures will include a physical exam; review of TB exposure history and medical history; collection of multiple samples of blood, urine, stool, tears, and nose fluid; and skin and blood tests for TB. Volunteers may participate for about 24 months.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Tuberculosis vaccines in clinical trials.
Rowland R, McShane H. · · 2011 · cited 76× · PMID 21604985 · DOI 10.1586/erv.11.28
Prime-boost approaches to tuberculosis vaccine development.
Dalmia N, Ramsay AJ. · · 2012 · cited 49× · PMID 23176655 · DOI 10.1586/erv.12.94
Blades and barriers: Oral vaccines for conquering cancers and warding off infectious diseases.
Yang K, Liu J, Zhao Y, Xu H, et al · · 2025 · PMID 40893667 · DOI 10.1016/j.apsb.2025.05.038

Verify or expand the search:

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Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

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NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00396370 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 12 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00396370.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing