Clinical Trials Logo

Clinical Trial Summary

In the last decade, the incidence of tuberculosis (TB) has declined in much of the world, but has increased in Central and South America. Since 2000, the prison population in these localizations has grown by 206%, the highest increase in the world. In the same period, the reported cases of TB among the prison population (PP) increased by 269%. The extraordinarily high risk of acquiring TB within prisons creates a health and human rights crisis for PP that also undermines broader TB control efforts. Same studies identified an annual incidence of 26,000 per 100,000 for latent TB infection (through conversion of the tuberculin skin test) and of 4,000 per 100,000 for active TB among the PP in the state of Mato Grosso do Sul. In view of the combination of a high rate of infection and development of active disease and a short period of incarceration (on average 3 years), primary prophylaxis with BCG revaccination may be a cost-effective alternative associated with mass screening for control of the disease. Recently, in a phase 2 clinical trial, the BCG vaccine was shown to be 45% effective in preventing sustained IGRA conversion in adolescents in South Africa. With this study, the investigators aim to evaluate the effectiveness of BCG revaccination for primary TB prophylaxis in healthy individuals exposed to an environment of high disease transmission. This is an open-label, randomized phase IV clinical trial involving 760 individuals from three prisons in the state of Mato Grosso do Sul. Participants will be monitored for 26 months to calculate vaccination effectiveness to reduce latent tuberculosis infection as measured through sustained IGRA conversion. By carrying out this clinical trial, the researchers intend to obtain scientific evidence that can contribute to the tuberculosis control policy in Brazil.


Clinical Trial Description

A randomized, open-label, phase IV clinical trial involving 760 prisoners to determine whether vaccination (or revaccination) with BCG reduces the incidence of latent tuberculosis infection (LTBI), as measured by the sustained conversion of the controlled release test of interferon gamma (IGRA) QuantiFERON TB Gold In Plus Qiagen (QFT). Participants will be randomized into two groups: intervention to receive the BCG vaccine or control, which will not receive intervention, and followed for 24 months through scheduled quarterly visits to identify QFT conversion. Additional information on treatment for latent tuberculosis infection (LTBi) or TB will be obtained from government databases (Notification grievances Information system and Latent Tuberculosis Infection Information System). Blood samples will be collected before randomization and every 6 months until the 24th month of follow-up or at the time of early departure from the correctional unit. When necessary, sputum samples will be collected and x-rays will be performed to evaluate suspected tuberculosis. 760 adults inmates , serving time in a closed regime, will be involved in the study. The main exclusion criteria are the contraindication of BCG vaccination and a positive result for QFT or HIV. Participants will be randomized 1:1 resulting in approximately 360 people per group. The research will be carried out in three prisons in the state of Mato Grosso do Sul, Brazil, Jair Ferreira de Carvalho Penal Establishment (EPJFC), Campo Grande Penal Institute (IPCG), both located in Campo Grande and Dourados State Penitentiary (PED), located in Dourados. Currently, approximately 6,300 adult males are held in these prisons, with an annual QFT conversion rate of 36% and an estimated TB incidence of 3.8% per year. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05541952
Study type Interventional
Source Federal University of Mato Grosso
Contact
Status Withdrawn
Phase Phase 4
Start date August 17, 2020
Completion date August 17, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05073926 - Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Not yet recruiting NCT04428294 - Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation Phase 4
Completed NCT02276755 - Vitamin D Supplementation in TB Prevention Phase 3
Withdrawn NCT03498534 - Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis Phase 4
Active, not recruiting NCT03988933 - 2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB. Phase 2
Recruiting NCT06022146 - TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts Phase 3
Active, not recruiting NCT04188041 - Improving Rhode Island's Tuberculosis Preventive Services in Primary Care N/A
Recruiting NCT03730181 - Tuberculosis Clinical Trials Consortium Study 35 Phase 1/Phase 2
Completed NCT01967134 - Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis Phase 1
Completed NCT00257907 - Immune Response to Mycobacterium Tuberculosis Infection
Recruiting NCT05756582 - Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
Active, not recruiting NCT04557176 - TB Screening Improves Preventive Therapy Uptake N/A
Completed NCT02119130 - Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa N/A
Not yet recruiting NCT06281834 - Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention Phase 1
Not yet recruiting NCT02512484 - Improving the Detection of Active Tuberculosis in Accident and Emergency Departments N/A
Completed NCT00763295 - Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV? N/A
Completed NCT01850043 - The Epidemiology of TST Change in Korea N/A
Completed NCT02073669 - Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults N/A
Completed NCT02090374 - Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen N/A
Completed NCT02880982 - Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren Phase 3