Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
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ClinicalTrials.gov Identifier: NCT03152903 |
Recruitment Status :
Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : April 8, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention of TB Recurrence | Biological: VPM1002 (Recombinant BCG Vaccine) Other: Placebo | Phase 2 Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 2000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | December 15, 2017 |
Estimated Primary Completion Date : | April 30, 2024 |
Estimated Study Completion Date : | July 30, 2024 |
Arm | Intervention/treatment |
---|---|
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. |
Placebo Comparator: Placebo |
Other: Placebo
Single dose of Placebo is administered intradermally. |
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152903
Bangladesh | |
International Centre for Diarrhoeal Disease Research | |
Dhaka, Bangladesh, 1212 | |
India | |
Mahavir Hospital & Research Centre, Hyderabad | |
Hyderabad, Andhra Pradesh, India, 500004 | |
Government Medical College, Jammu | |
Jammu, Jammu And Kashmir, India, 180001 | |
B.J. Govt. Medical College and Sassoon General Hospitals | |
Pune, Maharashtra, India, 411001 | |
Mahatma Gandhi Institute of Medical Sciences, Sevagram | |
Sevagram, Maharashtra, India, 442102 | |
Christian Medical College and Hospital, Ludhiana | |
Ludhiana, Punjab, India, 141008 | |
MV Hopsital for Diabetes Pvt Ltd, Chennai | |
Chennai, Tamil Nadu, India, 600013 | |
Sri Ramachandra Hospital Chennai | |
Chennai, Tamil Nadu, India, 600116 | |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry | |
Puducherry, Tamil Nadu, India, 605006 | |
Christian Medical College and Hospital, Vellore | |
Vellore, Tamil Nadu, India, 632004 |
Responsible Party: | Serum Institute of India Pvt. Ltd. |
ClinicalTrials.gov Identifier: | NCT03152903 |
Other Study ID Numbers: |
VPM1002-IN-3.01TBR |
First Posted: | May 15, 2017 Key Record Dates |
Last Update Posted: | April 8, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Recombinant BCG vaccine Category 1 pulmonary tuberculosis Recurrence Efficacy |
Recurrence Disease Attributes Pathologic Processes BCG Vaccine |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |