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CTRI Number  CTRI/2020/05/025421 [Registered on: 28/05/2020] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Trial to Investigate therapeutic Vaccine (RUTI) against Tuberculosis 
Scientific Title of Study   Double-Blind, Randomized, Placebo-Controlled, Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as adjuvant of Tuberculosis chemotherapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Randeep Guleria 
Designation  Director 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  All India Institute of Medical Sciences Ansari Nagar, New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  01126588500  
Fax  01126588500  
Email  randeepguleria2002@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dipendra K Mitra 
Designation  Professor and Head of the Department 
Affiliation  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences Ansari Nagar, New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  01126594638  
Fax  01126594638  
Email  salilmitra2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dipendra K Mitra 
Designation  Professor and Head of the Department 
Affiliation  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences Ansari Nagar, New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  01126594638  
Fax  01126594638  
Email  salilmitra2@gmail.com  
 
Source of Monetary or Material Support  
Archivel Farma SL 
 
Primary Sponsor  
Name  Archivel Farma SL 
Address  C / Fogars de Tordera, 61 08916 Badalona, Barcelona, Spain 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tapan Majumdar  Agartala Government Medical College  Tripura 799006
West Tripura
TRIPURA 		 9436120498

drtapan1960@gmail.com 
Prof Dipendra K Mitra  All India Institute of Medical Sciences  All India Institute of Medical Sciences Ansari Nagar, New Delhi-11002
New Delhi
DELHI 		 7838000282

salilmitra2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS  Approved 
Institutional Ethics Committee at Agartala Government Medical College and G.B Pant Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  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. 
Intervention  RUTI vaccine  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. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients with Sputum Culture Negative Difference between intervention and control group  Up to Week 2 for
Cohort A and Month 1.5 for Cohort B 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patients with Sputum Culture Negative Difference between intervention and control group  Up to Week 8 for
Cohort A and Month 6 for Cohort B 
Proportion of patients with reduction of bacillary load based upon Time to detection (TTD) signal in
MGIT. Difference between intervention and control group. 		 Up to Week 2 and 8
(Cohort A); and Months 1.5 and 6 (Cohort B) 
Proportion of patients with improvement of clinical signs and symptoms based upon Bandim Tb
score. Difference between intervention and control group. 		 Up to Week 2 and 8 (Cohort A); and Months 1.5 and 6 (Cohort B)  
Immunological Endpoints  Baseline (week 0),
week 1 (prior to vaccination) & week 8 (end of intensive phase) in Cohort A and baseline
(week 0), month 1.0 (prior to vaccination), month 3 & 6 (end of intensive phase) in Cohort B 
Safety Endpoints
Safety and tolerability (physical examination, serious adverse events (SAEs), routine
laboratory, chest radiography) and local injection effects between the intervention and control
group. 		 Throughout the trial period
 
Exploratory End Points
Percentage of patients with Sputum Culture Negative Difference between intervention and control
group 		 Up to Week 24 for
Cohort A and Month 12 & 24 for Cohort B 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is Double-Blind, Randomized, Placebo-Controlled Phase IIb Clinical Trial to Investigate the Efficacy of RUTI® Therapeutic Vaccination as adjuvant of Tuberculosis chemotherapy. A total of 140 adult TB patients (age > 18 years) with culture confirmed DS-TB (Drug Sensitive) (90 patients) (Cohort A) and MDR-TB (Multi Drug Resistant) (50 patients) (Cohort B) will be enrolled in the study. 25 μg RUTI® vaccine will be given subcutaneously in the deltoid region at the predefined time point (week 1 or month 1 upon start of standard DS- or MDR-TB treatment) respectively. The control group will receive a subcutaneous injection with placebo. The primary and secondary endpoint will be evaluated at the end of intensive phase of treatment however, all patients will be followed up for the whole chemotherapy treatment, i.e. 6 and 24 months for Cohort A and B respectively for exploratory endpoint analysis.

 
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