search
Back to results

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

Primary Purpose

Prevention of TB Recurrence

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VPM1002 (Recombinant BCG Vaccine)
Placebo
Sponsored by
Serum Institute of India Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of TB Recurrence focused on measuring Recombinant BCG vaccine, Category 1 pulmonary tuberculosis, Recurrence, Efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • International Centre for Diarrhoeal Disease Research
  • Mahavir Hospital & Research Centre, Hyderabad
  • Government Medical College, Jammu
  • B.J. Govt. Medical College and Sassoon General Hospitals
  • Mahatma Gandhi Institute of Medical Sciences, Sevagram
  • Christian Medical College and Hospital, Ludhiana
  • MV Hopsital for Diabetes Pvt Ltd, Chennai
  • Sri Ramachandra Hospital Chennai
  • Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
  • Christian Medical College and Hospital, Vellore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VPM1002 (Recombinant BCG vaccine)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
April 28, 2017
Last Updated
April 11, 2023
Sponsor
Serum Institute of India Pvt. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03152903
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serum Institute of India Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of TB Recurrence
Keywords
Recombinant BCG vaccine, Category 1 pulmonary tuberculosis, Recurrence, Efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VPM1002 (Recombinant BCG vaccine)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
VPM1002 (Recombinant BCG Vaccine)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single dose of Placebo is administered intradermally.
Primary Outcome Measure Information:
Title
Percentage of bacteriologically confirmed TB recurrence cases
Description
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.
Time Frame
2-12 months post-vaccination
Secondary Outcome Measure Information:
Title
Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence)
Description
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.
Time Frame
2-12 months post-vaccination
Title
Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs
Description
Solicited local and regional reactogenicity events within 2 months following study vaccination Unsolicited adverse events and SAEs throughout the study period
Time Frame
Throughout study participation i.e.12 months post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Reactive serology for HIV History of extrapulmonary TB Known or suspected impairment of immunological function Pregnant and / or lactating female participants
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
Facility Name
Mahavir Hospital & Research Centre, Hyderabad
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500004
Country
India
Facility Name
Government Medical College, Jammu
City
Jammu
State/Province
Jammu And Kashmir
ZIP/Postal Code
180001
Country
India
Facility Name
B.J. Govt. Medical College and Sassoon General Hospitals
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Mahatma Gandhi Institute of Medical Sciences, Sevagram
City
Sevagram
State/Province
Maharashtra
ZIP/Postal Code
442102
Country
India
Facility Name
Christian Medical College and Hospital, Ludhiana
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
MV Hopsital for Diabetes Pvt Ltd, Chennai
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600013
Country
India
Facility Name
Sri Ramachandra Hospital Chennai
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Facility Name
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
City
Puducherry
State/Province
Tamil Nadu
ZIP/Postal Code
605006
Country
India
Facility Name
Christian Medical College and Hospital, Vellore
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs