Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence

Phase 2

Completed

• Conditions: Prevention of TB Recurrence
• Interventions: Biological: VPM1002 (Recombinant BCG Vaccine); Other: Placebo

• Registration Number: NCT03152903
• Lead Sponsor: Serum Institute of India Pvt. Ltd.

Brief Summary

This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence.

Detailed Description

The study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of category 1 pulmonary TB patients who have successfully completed ATT and declared cured by bacteriological confirmation.

The eligible participants will be randomized in 1:1 ratio to receive single dose of either VPM1002 or placebo. After study vaccination, participants will be followed up for one year. Any suspected TB case during follow up will be further evaluated and bacteriologically confirmed. Study participants will be actively followed up for 2 months post-vaccination for any solicited local and regional reaction. SAEs will be recorded and reported throughout study participation.

Study Timeline

• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Study Start: 2017-12-15
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Males or females aged ≥18 and ≤65 years.
2. Bacteriologically confirmed Category I pulmonary TB patients (including controlled diabetics with HbA1c level ≤7% and non-diabetics) who successfully completed ATT as per national guidelines.
3. Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative.
4. Female participants who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination.
5. Participant must intend to remain in the area during the study period.

Exclusion Criteria

1. Reactive serology for HIV
2. History of extrapulmonary TB
3. Known or suspected impairment of immunological function
4. Pregnant and / or lactating female participants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VPM1002 (Recombinant BCG vaccine)	VPM1002 (Recombinant BCG Vaccine)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of bacteriologically confirmed TB recurrence cases	2-12 months post-vaccination	Percentage of TB recurrence patients who have previously been successfully treated for TB, were declared cure and are now diagnosed with a new episode of bacteriologically confirmed recurrent TB after at least 2 months from vaccination.

Secondary Outcome Measures

Name	Time	Method
Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)	2-12 months post-vaccination	Percentage of TB recurrence patients who have previously been successfully treated by for TB, were declared cure and are now diagnosed with a new episode of either bacteriologically confirmed or clinically diagnosed recurrent TB after at least 2 months from vaccination.
Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs	Throughout study participation i.e.12 months post-vaccination	* Solicited local and regional reactogenicity events within 2 months following study vaccination; * Unsolicited adverse events and SAEs throughout the study period

Trial Locations

Locations (10)

International Centre for Diarrhoeal Disease Research; 🇧🇩 Dhaka, Bangladesh

Mahavir Hospital & Research Centre, Hyderabad; 🇮🇳 Hyderabad, Andhra Pradesh, India

Government Medical College, Jammu; 🇮🇳 Jammu, Jammu and Kashmir, India

B.J. Govt. Medical College and Sassoon General Hospitals; 🇮🇳 Pune, Maharashtra, India

Mahatma Gandhi Institute of Medical Sciences, Sevagram; 🇮🇳 Sevagram, Maharashtra, India

Christian Medical College and Hospital, Ludhiana; 🇮🇳 Ludhiana, Punjab, India

MV Hopsital for Diabetes Pvt Ltd, Chennai; 🇮🇳 Chennai, Tamil Nadu, India

Sri Ramachandra Hospital Chennai; 🇮🇳 Chennai, Tamil Nadu, India

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry; 🇮🇳 Puducherry, Tamil Nadu, India

Christian Medical College and Hospital, Vellore; 🇮🇳 Vellore, Tamil Nadu, India