- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541952
BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population (PPT-BCG)
Study Overview
Detailed 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 Type
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Julio HR Croda, PhD
- Phone Number: +5567981229959
- Email: julio.croda@fiocruz.br
Study Locations
-
-
Mato Grosso Do Sul
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Dourados, Mato Grosso Do Sul, Brazil, 78824210
- Roberto Oliveira
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- QuantiFERON TB Plus Qiagen positive (Ag-Nil ≥0.20 IU / mL in both tubes).
- Reagent and / or undetermined result for HIV testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
|
Revaccination with BCG, using the immunobiological used in the Brazilian public health network, strain Russia.
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No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Latent Tuberculosis Infection (LTBI)
Time Frame: 6 months after the intervention.
|
Defined as the number of cases of LTBI detected during follow-up.
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6 months after the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of sustained IGRA conversion
Time Frame: 2 months
|
Defined as two tests with an Ag-Nil result ≥0.35
International Unit per milliliter (UI/ml) (in both tubes).
|
2 months
|
Incidence of active tuberculosis
Time Frame: Through study completion, an average of 24 months
|
Diagnosis of pulmonary tuberculosis by chest X-ray, or sputum culture, or Genexpert.
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Through study completion, an average of 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julio HR Croda, PhD, Federal University of Mato Grosso
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1236-5940
- 07657119.8.0000.0021 (Other Identifier: CAAE CEP/UFMS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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