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Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)

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ClinicalTrials.gov Identifier: NCT04919239
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : March 25, 2022
Information provided by (Responsible Party):
Archivel Farma S.L.

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.

Condition or disease Intervention/treatment Phase
Tuberculosis, Pulmonary Biological: RUTI® Biological: Placebo Phase 2

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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
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Biological: RUTI®
Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.

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.
Biological: Placebo
Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid muscle.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Percentage of patients with Sputum Culture Negative [ Time Frame: Up to Week 8 for Cohort A and Month 6 for Cohort B ]
    Difference between intervention and control group

  2. Proportion of patients with reduction of bacillary load [ Time Frame: Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B) ]
    Difference between intervention and control group based upon Time to detection (TTD) signal in MGIT

  3. Proportion of patients with improvement of clinical signs and symptoms [ Time Frame: Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B) ]
    Difference between intervention and control group based upon Bandin

Other Outcome Measures:
  1. Clinical safety parameters related to vaccination [ Time Frame: Through study completion, an average of 2 year ]
    Serious adverse events (SAEs) by CTCAE v4.0

  2. Local tolerability [ Time Frame: Up to Week 8 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in terms of site of injection for redness, pain, swelling, induration and functional limitation

Information from the National Library of Medicine

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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:

  1. Diagnosed with pulmonary DS- or MDR-TB, and managed with standard-care TB drugs accordingly;
  2. Attending a TB unit / hospital routinely diagnosed with pulmonary DS- or MDR-TB with clinical status ≥ 6 with Bandim TB score combined with chest radiography; and microbiological criteria (MGIT sputum culture), by using rapid genetic testing, gene Xpert;
  3. Patients who have not received any anti-tubercular treatment in last 6 months
  4. Females and males aged ≥ 18;

    • females of non-childbearing potential: at least 2 years post- menopausal or surgically sterile (e.g. tubal ligation);
    • females of childbearing potential (including females less than 2 years postmenopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control (i.e. diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in the study;
    • males must agree to use a double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide) while participating in the study; or the male patient or his female partner must be surgically sterile (e.g. vasectomy, tubal ligation) or the female partner must be post-menopausal;
  5. The patient must provide written informed consent;
  6. The patient must be willing and able to attend all study visits and comply with all study procedures.

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:

  1. Inability to provide written informed consent;
  2. Women reported, or detected, or willing to be pregnant during the trial period;
  3. Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
  4. Patients with extra-pulmonary tuberculosis
  5. Major co-morbid conditions precluding full evaluation, i.e., HIV positive, chronic renal failure, chronic liver failure, Malignancy, patients taking any immunosuppressant drug, active lung cancer, acute coronary syndrome, heart failure exceeding NYHA class 2;
  6. Presence of secondary immunodeficiency states: Organ transplantation, diabetes mellitus
  7. Any of the following laboratory parameters:

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
    • Total bilirubin > 2 x ULN
    • Neutrophil count ≤ 500 neutrophils / mm3
    • Platelet count < 50,000 cells / mm3
  8. Cytotoxic chemotherapy or radiation therapy within the previous 3 months;
  9. Blood transfusion in the last three weeks prior to the trial; 10.Patients with history of alcohol or drug abuse

11. Documented allergy to TB vaccines, notably, to the RUTI® vaccine

Information from the National Library of Medicine

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): NCT04919239

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Contact: Dipendra K Mitra, Prof 01126588500 salilmitra2@gmail.com

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All India Institute of Medical Sciences (AIIMS) Recruiting
New Delhi, India, 11002
Contact: Dipendra K Mitra, Prof.       salilmitra2@gmail.com   
Agartala Government Medical College (AGMC) Recruiting
Tripura, India, 799006
Contact: Tapan Majumdar, Dr       drtapan1960@gmail.com   
Sponsors and Collaborators
Archivel Farma S.L.
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Principal Investigator: Randeep Guleria, Prof All India Institute of Medical Sciences, New Delhi
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Responsible Party: Archivel Farma S.L.
ClinicalTrials.gov Identifier: NCT04919239    
Other Study ID Numbers: RUTIP2-2019-01
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases