Condition or disease | Intervention/treatment | Phase |
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Tuberculosis, Pulmonary | Biological: RUTI® Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-Blind, Randomized, Placebo-Controlled, Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as Adjuvant of Tuberculosis Chemotherapy |
Estimated Study Start Date : | September 2021 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | September 2023 |
Arm | Intervention/treatment |
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Experimental: RUTI® arm
A dose of 25 μg of of RUTI vaccine will be given at week 1 (Cohort A-DS TB Patients) or month 1 (Cohort B-MDR TB Patients) after starting standard TB treatment.
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Biological: RUTI®
Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.
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Placebo Comparator: Placebo arm
Placebo will be given at week 1 (Cohort A-DS TB Patients) or month 1 (Cohort B-MDR TB Patients) after starting standard TB treatment.
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Biological: Placebo
Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid muscle.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Females and males aged ≥ 18;
Inclusion criteria for vaccination
1. Having successfully completed 1 week or 1 month (depending on the cohort) of DS or MDR-TB treatment, respectively, fully supervised; and with beneficial initial response to therapy, evidenced by clinical response.
Exclusion Criteria:
Any of the following laboratory parameters:
11. Documented allergy to TB vaccines, notably, to the RUTI® vaccine
Contact: Dipendra K Mitra, Prof | 01126588500 | salilmitra2@gmail.com |
India | |
All India Institute of Medical Sciences | |
New Delhi, India, 11002 | |
Contact: Dipendra K Mitra, Prof. salilmitra2@gmail.com | |
Agartala Government Medical College | |
Tripura, India, 799006 | |
Contact: Tapan Majumdar, Dr drtapan1960@gmail.com |
Principal Investigator: | Randeep Guleria, Prof | All India Institute of Medical Sciences, New Delhi |
Tracking Information | |||||
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First Submitted Date ICMJE | May 31, 2021 | ||||
First Posted Date ICMJE | June 9, 2021 | ||||
Last Update Posted Date | June 9, 2021 | ||||
Estimated Study Start Date ICMJE | September 2021 | ||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percentage of patients with Sputum Culture Negative [ Time Frame: Up to Week 2 for Cohort A and Month 1.5 for Cohort B ] Difference between intervention and control group
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB) | ||||
Official Title ICMJE | Double-Blind, Randomized, Placebo-Controlled, Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as Adjuvant of Tuberculosis Chemotherapy | ||||
Brief Summary | Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts upon completion of 1 week of standard DS-TB treatment (cohort A), and another cohort of patients will be vaccinated upon completion of 1 month of standard MDR-TB treatment (cohort B). All the patients will be followed up to the end of the treatment. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Tuberculosis, Pulmonary | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
140 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 2023 | ||||
Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Inclusion criteria for vaccination 1. Having successfully completed 1 week or 1 month (depending on the cohort) of DS or MDR-TB treatment, respectively, fully supervised; and with beneficial initial response to therapy, evidenced by clinical response. Exclusion Criteria:
11. Documented allergy to TB vaccines, notably, to the RUTI® vaccine |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | India | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04919239 | ||||
Other Study ID Numbers ICMJE | RUTIP2-2019-01 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Archivel Farma S.L. | ||||
Study Sponsor ICMJE | Archivel Farma S.L. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Archivel Farma S.L. | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |