None listed
Conditions
Interventions
Intervention1: 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 mycobacteria
CFU) per application.
Frequency: 0.1ml intradermal
single dose
Intervention2: IMMUVAC: Immuvac is a heat killed suspension of Mycobacterium w, a non-pathogenic, cultivable atypical mycobacterium. Fr
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 > 100°F 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/assent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the percentage of confirmed TB cases (PTB and EPTB) as per RNTCP guidelines in the vaccinated and placebo groups from 2 months after first dose of vaccine till 38 months follow-up period (VPM1002, Immuvac and Placebo).Timepoint: 1 year, 2 year and 3 year post-vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants developing LTBI, adverse events, protection from all types of TB and Immune Response to Vaccines.Timepoint: LTBI-6 months, Adverse events-after vaccination till end of study period. Immune Response-day 0, 2 months, 6 months, and at the time of deveopment of TB. | — |
Countries
India
Contacts
Public ContactDr Manjula Singh
ICMR
Outcome results
None listed