Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of category 1 pulmonary TB patients who have successfully completed ATT and declared cured by bacteriological confirmation.
The eligible participants will be randomized in 1:1 ratio to receive single dose of either VPM1002 or placebo. After study vaccination, participants will be followed up for one year. Any suspected TB case during follow up will be further evaluated and bacteriologically confirmed. Study participants will be actively followed up for 2 months post-vaccination for any solicited local and regional reaction. SAEs will be recorded and reported throughout study participation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VPM1002 (Recombinant BCG vaccine) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPM1002 (Recombinant BCG Vaccine) | Biological | VPM1002 is a formulated, lyophilized cake of live recombinant Mycobacterium bovis rBCGÄureC::Hly+; VPM1002. VPM1002 is the active pharmaceutical ingredient. It is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. Single dose of VPM1002 is administered intradermally. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research | Dhaka | 1212 | Bangladesh | |||
| Mahavir Hospital & Research Centre, Hyderabad |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39752894 | Derived | Giersing B, Mo AX, Hwang A, Baqar S, Earle K, Ford A, Deal C, Dull P, Friede M, Hall BF. Meeting summary: Global vaccine and immunization research forum, 2023. Vaccine. 2025 Feb 6;46:126686. doi: 10.1016/j.vaccine.2024.126686. Epub 2025 Jan 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Single dose of Placebo is administered intradermally. |
|
| Safety assessed by Solicited local and regional reactogenicity and Unsolicited adverse events and SAEs |
| Throughout study participation i.e.12 months post-vaccination |
| Hyderabad |
| Andhra Pradesh |
| 500004 |
| India |
| Government Medical College, Jammu | Jammu | Jammu and Kashmir | 180001 | India |
| B.J. Govt. Medical College and Sassoon General Hospitals | Pune | Maharashtra | 411001 | India |
| Mahatma Gandhi Institute of Medical Sciences, Sevagram | Sevāgrām | Maharashtra | 442102 | India |
| Christian Medical College and Hospital, Ludhiana | Ludhiana | Punjab | 141008 | India |
| MV Hopsital for Diabetes Pvt Ltd, Chennai | Chennai | Tamil Nadu | 600013 | India |
| Sri Ramachandra Hospital Chennai | Chennai | Tamil Nadu | 600116 | India |
| Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry | Puducherry | Tamil Nadu | 605006 | India |
| Christian Medical College and Hospital, Vellore | Vellore | Tamil Nadu | 632004 | India |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705187 | VPM1002 recombinant BCG vaccine |
Not provided
Not provided
Not provided