Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence

Launched by SERUM INSTITUTE OF INDIA PVT. LTD. · May 12, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called VPM1002, which aims to prevent the recurrence of tuberculosis (TB) in adults who have already been successfully treated for the disease. The trial involves two groups of adults aged 18 to 65 who have been cured of a specific type of TB known as Category I pulmonary TB. One group will receive the VPM1002 vaccine, while the other group will receive a placebo (a harmless substance with no therapeutic effect). The main goal is to see how effective the vaccine is in stopping TB from coming back.

To be eligible for this trial, participants must have had a confirmed diagnosis of TB and successfully completed their treatment. They should also have a negative sputum test, meaning they no longer have active TB bacteria in their system. Women who wish to participate need to be using reliable birth control and not plan to become pregnant for at least three months after receiving the vaccine. Participants will need to stay in the area throughout the study and cannot have certain health issues, such as a history of HIV or problems with their immune system. If you join the trial, you can expect to receive either the vaccine or placebo and help researchers learn more about preventing TB recurrence.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females aged ≥18 and ≤65 years.
• • 2. Bacteriologically confirmed Category I pulmonary TB patients (including controlled diabetics with HbA1c level ≤7% and non-diabetics) who successfully completed ATT as per national guidelines.
• • 3. Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative.
• • 4. Female participants who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination.
• • 5. Participant must intend to remain in the area during the study period.
• Exclusion Criteria:
• • 1. Reactive serology for HIV
• • 2. History of extrapulmonary TB
• • 3. Known or suspected impairment of immunological function
• • 4. Pregnant and / or lactating female participants