Table 2.
Pediatric tuberculosis prevention research.
| Study Name | Intervention | Population | Sponsor | Status |
|---|---|---|---|---|
| TB Preventive Treatment (TPT) | ||||
| TBTC Study 35 NCT03730181 |
Phase 1/2 trial evaluating the PK and safety of 3HP | Children 0–12 years old with and without HIV | CDC TBTC | Opened October 2019 Enrolling Expected completion: 2023 |
| DOLPHIN Kids | Phase 1/2 trial evaluating the PK and safety of 3HP with DTG-based ART | Adolescents and children with HIV 4 weeks-18 years old on DTG-based ART | Unitaid via IMPAACT4TB | Planned |
| IMPAACT P2024 | Phase 1/2 trial evaluating the PK and safety of 1HP, including when given with DTG-based ART | Children 2–13 years old with and without HIV | NIH via IMPAACT | Planned |
| V-QUIN ACTRN12616000215426 |
Phase 3 trial evaluating the safety and efficacy of 6 months of levofloxacin vs. placebo | Adult and adolescent household contacts of people with MDR-TB 15 years and older | Australian NHMRC, Government of Vietnam | Opened March 2016 Fully enrolled Expected completion: 2022 |
| TB CHAMP ISRCTN92634082 |
Phase 3 trial evaluating the safety and efficacy of 6 months of levofloxacin vs. placebo | Child household contacts <5 years of age of people with MDR-TB | Unitaid, South African MRC, Wellcome Trust, British MRC | Opened January 2016 Enrolling Expected completion: 2023 |
| PHOENIx NCT03568383 |
Phase 3 trial evaluating the safety and efficacy of 6 months of delamanid vs. isoniazid | Adult, adolescent, and child household contacts of people with MDR-TB | NIH via ACTG and IMPAACT | Opened June 2019 Enrolling Expected completion: 2025 |
| TB Vaccines | ||||
| CTRI/2019/01/017026 | Phase 3 trial evaluating the efficacy, safety, and immunogenicity of MIP and VPM1002 (vs. placebo) in preventing TB disease. Secondary objectives include efficacy evaluation for preventing TB infection |
HHC (≥6 years old, HIV negative) of people with TB | Indian Council of Medical Research (ICMR) | Opened January 2019 Expected completion: 2022 |
| NCT04351685 | Phase 3 trial evaluating the efficacy, safety, and immunogenicity of VPM1002 (vs. BCG) in preventing TB infection. |
Newborn infants (HIV-exposed and uninfected eligible) | Serum Institute of India Pvt. Ltd. | Opened November 2020 Expected completion: July 2023 |
| NCT04975178 | Phase 3 trial to evaluate the efficacy, safety, and immunogenicity of MTBVAC (vs. BCG) | HIV unexposed and HIV-exposed infants |
Biofabri | Planned |
| NCT04152161 | Phase 2b study to evaluate the efficacy, safety, and immunogenicity of BCG revaccination (vs. placebo) |
BCG-vaccinated, MTB-uninfected adolescents | Bill & Melinda Gates Medical Research Institute | Opened October 2019 Expected completion: April 2023 |