BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population

NCT05541952 | Withdrawn Phase 4

• 2 other identifiers: U1111-1236-594007657119.8.0000.0021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Latent Tuberculosis

Keywords

Latent tuberculosis infection; Clinical trial; BCG re-vaccination; Interferon gamma

Outcome Measures

Primary Outcomes (1)

• Incidence of Latent Tuberculosis Infection (LTBI)

  Defined as the number of cases of LTBI detected during follow-up.

  6 months after the intervention.

Secondary Outcomes (2)

• Percentage of sustained IGRA conversion

  2 months

• Incidence of active tuberculosis

  Through study completion, an average of 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will receive the 0.1 milliliter (mL) dose of BCG vaccine intradermally in the deltoid muscle region at the lower insertion level on the upper outer face of the right arm. When this recommendation can not be followed, the participant will be excluded from the study.

Biological: BCG

Control

NO INTERVENTION

Participants assigned to the control arm will not receive any intervention and will be followed up with QFT and Genexpert for the detection of Mtb infection or diagnosis of tuberculosis.

Interventions

BCG BIOLOGICAL

Revaccination with BCG, using the immunobiological used in the Brazilian public health network, strain Russia.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No previous prison history.
• Be locked up for a maximum of 3 months.
• Have at least 24 months of unfulfilled penalty in a closed regime.
• No history or evidence of any clinically significant systemic disease, or any acute or chronic disease that may affect the safety, immunogenicity, or efficacy of the study vaccine.
• No history of treatment for active TB or latent Mtb infection.
• No history or evidence of active TB.
• No history of autoimmune disease or immunosuppression.
• No immunosuppressant medication in the last 30 days before intervention (D0) - with the exception of inhaled and topical corticosteroids.
• No lesions or any localized dermal changes at the insertion of the deltoid muscle.
• No history of allergic disease or reactions, including eczema, probably exacerbated by any component of the study vaccine.

You may not qualify if:

• QuantiFERON TB Plus Qiagen positive (Ag-Nil ≥0.20 IU / mL in both tubes).
• Reagent and / or undetermined result for HIV testing.

Sponsors & Collaborators

• Federal University of Mato Grosso: lead
• Stanford University: collaborator
• Oswaldo Cruz Foundation: collaborator

Study Sites (1)

Roberto Oliveira

Dourados, Mato Grosso do Sul, 78824210, Brazil

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Julio HR Croda, PhD

  Federal University of Mato Grosso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Research

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: September 15, 2022
• Study Start: August 17, 2020
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

BR (1)