None listed
Conditions
Interventions
Intervention1: VPM1002: VPM1002: The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis rBCG?ureC: Hly+, freeze-dried/lyophilized and standardized to number of viable myc
CFU) per application. Frequency: 0.1ml intradermal single dose
Intervention2: Nil: Nil
Control Intervention1: Placebo: Placebo: Aqueous solution containing thiomerosal (0.1 mg/ml), sodium chloride (py
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: i. Healthy household contacts age 6 years at the time of enrollment. ii. No evidence of active TB disease during screening Normal chest radiograph with no abnormalities and no bacteriological positivity by smear testing for M.tb iii. Female participants who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 4 months post-vaccination. iv. The participant must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form. v. Participant agrees to stay in contact with the study site for the duration of the study, and provide updated and an alternate contact information. vi. Has general good health, as confirmed through medical history and medical evaluation (which includes physical examination and laboratory tests).
Exclusion criteria
Exclusion criteria: i. Any chronic febrile illness with oral temperature more than 100F on the day of randomization. ii. Prior or present anti-TB treatment iii. Any laboratory abnormalities (haematological and biochemical), at the time of screening, which is of clinical significance as determined by the Investigator. iv. Pregnant and or lactating female participants. v. Presence of any illness requiring short hospital referral (temporary exclusion). vi. Reactive serology for HIV. vii. Any confirmed or suspected immunodeficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency. viii. History of chronic renal failure/dialysis, silicosis, gastrectomy, jejunoileal bypass, solid organ transplantation such as renal or cardiac transplants, carcinoma of the head and neck, and disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely the volunteer will comply with the protocol as determined by the local investigator. ix. History of previous administration of experimental MTB vaccines. x. History of administration of any immunoglobulins, any immunotherapy, antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use and/or any blood products within the 3 months preceding study vaccination, or planned future administrations during the study period. Participants on inhaled/topical steroids may be permitted to participate in the study. xi. Participation in any clinical trial within 3 months prior to and/or planned concurrent participation in another interventional clinical trial at any point throughout the entire timeframe for this study. xii. History of allergic reactions or anaphylaxis to any vaccine or component of the vaccine. xiii. Presence of any severe systemic/autoimmune disorders as determined by medical history and or physical examination/ or lab investigations at the time of screening, which in the judgment of the Investigator would compromise the participant s health or is likely to result in nonconformance to the protocol or a participant s ability to give written informed consent or assent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of microbiologically confirmed TB (PTB and EPTB) cases in VPM1002 vaccine arm and the placebo arm and vaccine effectiveness in the prevention of TB disease at 5 to 6 years post-vaccination.Timepoint: 5 to 6 years follow-up post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of incident TB cases in VPM1002 vaccine arm and the placebo arm and vaccine effectiveness in the prevention of TB disease in various age groups - (6 to18 years,19 to 35 years, 36 to 60 years and above 60 years) at 5 to 6 years post-vaccination. 2. Proportion of incident TB cases (microbiologically confirmed and clinically diagnosed) in VPM1002 vaccine arm and placebo arm and vaccine effectiveness in the prevention of TB disease at Page 3 of 20 5 to 6 years post-vaccination. 3. Difference in the proportion of individuals who died in the vaccine and placebo arms among the household contacts at 5 to 6 years follow-up post-vaccination. Timepoint: 5 to 6 years follow-up post-vaccination | — |
Countries
India
Contacts
Public ContactDr Banu Rekha VV
ICMR National Institute for Research in Tuberculosis
Outcome results
None listed