Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence in India
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|ClinicalTrials.gov Identifier: NCT03152903|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : February 28, 2018
|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)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 In India|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||August 20, 2019|
|Estimated Study Completion Date :||November 20, 2019|
|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||
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
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
|Contact: Dr Prasad Kulkarni, MDemail@example.com|
|Contact: Dr Sajjad Desai, MDfirstname.lastname@example.org|
|Mahavir Hospital & Research Centre, Hyderabad||Recruiting|
|Hyderabad, Andhra Pradesh, India, 500004|
|Contact: Dr Penmetsa Sitarama Raju +91-9247251879 email@example.com|
|B.J. Govt. Medical College and Sassoon General Hospitals||Recruiting|
|Pune, Maharashtra, India, 411001|
|Contact: Dr Sushant Meshram +91-20-26052419 firstname.lastname@example.org|
|Mahatma Gandhi Institute of Medical Sciences, Sevagram||Recruiting|
|Sevagram, Maharashtra, India, 442102|
|Contact: Dr B S Garg, MD +91-9422141693 email@example.com|
|Christian Medical College and Hospital, Ludhiana||Recruiting|
|Ludhiana, Punjab, India, 141008|
|Contact: Dr Clarence Samuel firstname.lastname@example.org|
|MV Hopsital for Diabetes Pvt Ltd, Chennai||Recruiting|
|Chennai, Tamil Nadu, India, 600013|
|Contact: Dr Vijay Viswanathan +91-44-25954913 email@example.com|