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

• ClinicalTrials.gov Identifier: NCT03152903
• Recruitment Status: Active, not recruiting
• First Posted: May 15, 2017
• Last Update Posted: April 8, 2024
• Sponsor: Serum Institute of India Pvt. Ltd.
• Information provided by (Responsible Party): Serum Institute of India Pvt. Ltd.

Tracking Information

• First Submitted Date: April 28, 2017
• First Posted Date: May 15, 2017
• Last Update Posted Date: April 8, 2024
• Actual Study Start Date: December 15, 2017
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 12, 2017)

Percentage of bacteriologically confirmed TB recurrence cases [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 12, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
• Official Title: 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
• 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 Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Prevention of TB Recurrence

Intervention

• 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.

• Other: Placebo
  Single dose of Placebo is administered intradermally.

Study Arms

• Experimental: VPM1002 (Recombinant BCG vaccine)
  Intervention: Biological: VPM1002 (Recombinant BCG Vaccine)
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 12, 2017): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2024
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bangladesh, India

Administrative Information

• NCT Number: NCT03152903
• Other Study ID Numbers: VPM1002-IN-3.01TBR
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Serum Institute of India Pvt. Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Serum Institute of India Pvt. Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Serum Institute of India Pvt. Ltd.
• Verification Date: April 2024