Prevention of TB Recurrence Clinical Trial
Official title:
A Multicenter Phase II/III Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Efficacy And Safety Of VPM1002 In The Prevention Of Tuberculosis (TB) Recurrence In Pulmonary TB Patients After Successful TB Treatment
| Verified date | April 2024 |
| Source | Serum Institute of India Pvt. Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence.
| Status | Active, not recruiting |
| Enrollment | 2000 |
| Est. completion date | July 30, 2024 |
| Est. primary completion date | April 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | International Centre for Diarrhoeal Disease Research | Dhaka | |
| India | MV Hopsital for Diabetes Pvt Ltd, Chennai | Chennai | Tamil Nadu |
| India | Sri Ramachandra Hospital Chennai | Chennai | Tamil Nadu |
| India | Mahavir Hospital & Research Centre, Hyderabad | Hyderabad | Andhra Pradesh |
| India | Government Medical College, Jammu | Jammu | Jammu And Kashmir |
| India | Christian Medical College and Hospital, Ludhiana | Ludhiana | Punjab |
| India | Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry | Puducherry | Tamil Nadu |
| India | B.J. Govt. Medical College and Sassoon General Hospitals | Pune | Maharashtra |
| India | Mahatma Gandhi Institute of Medical Sciences, Sevagram | Sevagram | Maharashtra |
| India | Christian Medical College and Hospital, Vellore | Vellore | Tamil Nadu |
| Lead Sponsor | Collaborator |
|---|---|
| Serum Institute of India Pvt. Ltd. |
Bangladesh, India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of bacteriologically confirmed TB recurrence cases | Percentage of TB recurrence patients who have previously been successfully treated for TB, were declared cure and are now diagnosed with a new episode of bacteriologically confirmed recurrent TB after at least 2 months from vaccination. | 2-12 months post-vaccination | |
| Secondary | Percentage of overall TB recurrence (i.e. either bacteriologically confirmed or clinically diagnosed TB recurrence) | Percentage of TB recurrence patients who have previously been successfully treated by for TB, were declared cure and are now diagnosed with a new episode of either bacteriologically confirmed or clinically diagnosed recurrent TB after at least 2 months from vaccination. | 2-12 months post-vaccination | |
| Secondary | Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs | Solicited local and regional reactogenicity events within 2 months following study vaccination
Unsolicited adverse events and SAEs throughout the study period |
Throughout study participation i.e.12 months post-vaccination |