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

NCT03152903 | Completed Phase 2 DMC

• 1 other identifier: VPM1002-IN-3.01TBR
• Study Type: interventional
• Target: 2,000
• Locations: 2 countries
• Sites: 10

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.

Conditions

Prevention of TB Recurrence

Keywords

Recombinant BCG vaccine; Category 1 pulmonary tuberculosis; Recurrence; Efficacy

Outcome Measures

Primary Outcomes (1)

• Percentage of bacteriologically confirmed TB recurrence cases

  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.

  2-12 months post-vaccination

Secondary Outcomes (2)

• Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)

  2-12 months post-vaccination

• Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs

  Throughout study participation i.e.12 months post-vaccination

Study Arms (2)

VPM1002 (Recombinant BCG vaccine)

EXPERIMENTAL

Biological: VPM1002 (Recombinant BCG Vaccine)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

VPM1002 (Recombinant BCG Vaccine) BIOLOGICAL

VPM1002 is a formulated, lyophilized cake of live recombinant Mycobacterium bovis rBCGÄureC::Hly+; VPM1002. VPM1002 is the active pharmaceutical ingredient. It is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. Single dose of VPM1002 is administered intradermally.

VPM1002 (Recombinant BCG vaccine)

Placebo OTHER

Single dose of Placebo is administered intradermally.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥18 and ≤65 years.
• 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.
• Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative.
• 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.
• Participant must intend to remain in the area during the study period.

You may not qualify if:

• Reactive serology for HIV
• History of extrapulmonary TB
• Known or suspected impairment of immunological function
• Pregnant and / or lactating female participants

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead

Study Sites (10)

International Centre for Diarrhoeal Disease Research

Dhaka, 1212, Bangladesh

Location

Mahavir Hospital & Research Centre, Hyderabad

Hyderabad, Andhra Pradesh, 500004, India

Location

Government Medical College, Jammu

Jammu, Jammu and Kashmir, 180001, India

Location

B.J. Govt. Medical College and Sassoon General Hospitals

Pune, Maharashtra, 411001, India

Location

Mahatma Gandhi Institute of Medical Sciences, Sevagram

Sevāgrām, Maharashtra, 442102, India

Location

Christian Medical College and Hospital, Ludhiana

Ludhiana, Punjab, 141008, India

Location

MV Hopsital for Diabetes Pvt Ltd, Chennai

Chennai, Tamil Nadu, 600013, India

Location

Sri Ramachandra Hospital Chennai

Chennai, Tamil Nadu, 600116, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

Puducherry, Tamil Nadu, 605006, India

Location

Christian Medical College and Hospital, Vellore

Vellore, Tamil Nadu, 632004, India

Location

Related Publications (1)

• Giersing B, Mo AX, Hwang A, Baqar S, Earle K, Ford A, Deal C, Dull P, Friede M, Hall BF. Meeting summary: Global vaccine and immunization research forum, 2023. Vaccine. 2025 Feb 6;46:126686. doi: 10.1016/j.vaccine.2024.126686. Epub 2025 Jan 5.

  PMID: 39752894 DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

VPM1002 recombinant BCG vaccine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 15, 2017
• Study Start: December 15, 2017
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (9); BA (1)