Latent TuberculosisPhase 4PPT-BCGNCT05541952
BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population
A Phase 4 study testing BCG in people with Latent Tuberculosis, run by Federal University of Mato Grosso at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- BCG
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Aug 2020to 17 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- QuantiFERON TB Plus Qiagen positive (Ag-Nil ≥0.20 IU / mL in both tubes).
- Reagent and / or undetermined result for HIV testing.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Latent Tuberculosis
- Being tested
- BCG
- Keywords
- Latent tuberculosis infection, Clinical trial, BCG re-vaccination, Interferon gamma
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCGBiological
Revaccination with BCG, using the immunobiological used in the Brazilian public health network, strain Russia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Latent Tuberculosis Infection (LTBI)
Defined as the number of cases of LTBI detected during follow-up.
Measured: 6 months after the intervention.
Secondary outcomes (2)
Percentage of sustained IGRA conversion
Defined as two tests with an Ag-Nil result ≥0.35 International Unit per milliliter (UI/ml) (in both tubes).
Measured: 2 months
Incidence of active tuberculosis
Diagnosis of pulmonary tuberculosis by chest X-ray, or sputum culture, or Genexpert.
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start17 Aug 2020 (estimated)
- Primary completion17 Aug 2020 (estimated)
- Study completion17 Aug 2020 (estimated)
Why it stopped: New evidence points to a new candidate vaccine, with a superior trial to BCG.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Oswaldo Cruz Foundation
- Responsible party
- Principal investigator, Roberto D Oliveira, Federal University of Mato Grosso
- Investigators
- Julio HR Croda, PhD, Principal investigator, Federal University of Mato Grosso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541952
- Sponsor's protocol ID
- U1111-1236-5940
- Other IDs
- 07657119.8.0000.0021
- Acronym
- PPT-BCG
- Status last verified
- Oct 2023
- First submitted
- 25 Jul 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population
- ClinicalTrials.gov ID
- NCT05541952
- Acronym / sponsor ID
- PPT-BCG / U1111-1236-5940
- Conditions
- Latent Tuberculosis
- Keywords
- Latent tuberculosis infection, Clinical trial, BCG re-vaccination, Interferon gamma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New evidence points to a new candidate vaccine, with a superior trial to BCG.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Collaborators
- Stanford University, Oswaldo Cruz Foundation
- Study start
- 17 Aug 2020 (estimated)
- Primary completion
- 17 Aug 2020 (estimated)
- Study completion
- 17 Aug 2020 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: BCGThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- QuantiFERON TB Plus Qiagen positive (Ag-Nil ≥0.20 IU / mL in both tubes).
- Reagent and / or undetermined result for HIV testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCGRevaccination with BCG, using the immunobiological used in the Brazilian public health network, strain Russia. | Biological | Intervention |
Primary outcome
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.
2 secondary outcomes
Percentage of sustained IGRA conversion
Time frame: 2 months
Incidence of active tuberculosis
Time frame: Through study completion, an average of 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio HR Croda, PhD principal investigator
Federal University of Mato Grosso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BCG in people with Latent Tuberculosis, run by Federal University of Mato Grosso at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Latent Tuberculosis Infection (LTBI) (time frame: 6 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.