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

A Multicenter Phase II/III Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Efficacy And Safety Of VPM1002 In The Prevention Of Tuberculosis (TB) Recurrence In Pulmonary TB Patients After Successful TB Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prevention of TB Recurrence
• Intervention / Treatment: Biological: VPM1002 (Recombinant BCG Vaccine); Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 2000
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Dr Prasad Kulkarni, MD; Phone Number: +91-20-26602384; Email: drpsk@seruminstitute.com
• Study Contact Backup: Name: Dr Sajjad Desai, MD; Phone Number: +91-20-26602781; Email: sajjad.desai@seruminstitute.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1212
    • International Centre for Diarrhoeal Disease Research
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500004
      • Mahavir Hospital & Research Centre, Hyderabad
  • Jammu And Kashmir
    • Jammu, Jammu And Kashmir, India, 180001
      • Government Medical College, Jammu
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • B.J. Govt. Medical College and Sassoon General Hospitals
    • Sevagram, Maharashtra, India, 442102
      • Mahatma Gandhi Institute of Medical Sciences, Sevagram
  • Punjab
    • Ludhiana, Punjab, India, 141008
      • Christian Medical College and Hospital, Ludhiana
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600013
      • MV Hopsital for Diabetes Pvt Ltd, Chennai
    • Chennai, Tamil Nadu, India, 600116
      • Sri Ramachandra Hospital Chennai
    • Puducherry, Tamil Nadu, India, 605006
      • Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
    • Vellore, Tamil Nadu, India, 632004
      • Christian Medical College and Hospital, Vellore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Single dose of Placebo is administered intradermally.
Experimental: VPM1002 (Recombinant BCG vaccine)	Biological: VPM1002 (Recombinant BCG Vaccine); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)	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.	2-12 months post-vaccination
Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs	Solicited local and regional reactogenicity events within 2 months following study vaccination; Unsolicited adverse events and SAEs throughout the study period	Throughout study participation i.e.12 months post-vaccination

Collaborators and Investigators

• Sponsor: Serum Institute of India Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Efficacy; Recurrence; Recombinant BCG vaccine; Category 1 pulmonary tuberculosis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; BCG Vaccine
• Other Study ID Numbers: VPM1002-IN-3.01TBR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No