MalariaPhase 4NCT00126217
Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine
A Phase 4 study testing Bacille Calmette Guerin (BCG) in people with Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality. Read more about this study
- Who is it for?
- Ages 19 to 24 months
- Conditions the study is for
- Malaria
- What is being tested?
- Bacille Calmette Guerin (BCG)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,871 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Jul 2002to Sep 2006
- 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 19 to 24 months
- All sexes
- Child
Who may be able to join
- No overt illness
Who cannot join
- PPD reaction >15mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BCG Vaccination and Childhood Morbidity and Mortality: Interventions With Possible Implications for the Immunisation Policy in Developing Countries. Revaccination of Young Children With BCG Vaccine.
BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality. The specific objective of the study is to examine the effect of revaccination for purified protein derivative of tuberculin (PPD) reaction, scar size, morbidity and mortality in a randomised prospective study of revaccination versus no revaccination among children 19 months of age in Guinea-Bissau. The hypothesis is that revaccination with BCG reduces childhood mortality after 19 months of age by 30%.
Read the detailed description
Examine in a randomised trial whether revaccination with BCG reduces childhood mortality after 19 months of age by 30%.
Criteria for verification: 3,000 children aged 1½ year enrolled and followed for an average of 3 years; information on potential adverse events among children with a positive PPD reaction; assessment of parasitaemia after revaccination; assessment of the tuberculin response and scar-formation after revaccination; and assessment of all-cause mortality during the period of follow-up.
Following consent to participate, children will be assessed for BCG scar and tuberculin reaction at 18-19 months of age. Subsequently, the children will be invited to a clinical examination at one of the health centres. The study will be explained again to the mother, and if she accepts to participate, she will draw a randomisation number deciding whether the child will be revaccinated or not. The BCG vaccine given will be the standard dose of 0.1 ml as recommended by WHO in this age group. In the beginning of the study, a group of 800 revaccinated and not revaccinated children will be followed weekly for two months to monitor morbidity and possible adverse effects of the vaccination. It is not expected that Koch like reactions will be common in this age group. However, should there be too many adverse reactions among children with a positive tuberculin test, only tuberculin negative children will be included in the continuation of the trial.
Two months after inclusion, the children will have another tuberculin test to examine changes in tuberculin reaction. At the same time, scar-size will be measured. In the initial phase of the project, a finger-prick blood sample will be collected from 1000 children to examine whether BCG boosting/no boosting have had an effect on the prevalence of malaria parasitaemia and the level of measles antibodies. Children with malaria will be treated and children with non-protective levels of measles antibodies will be offered revaccination with measles vaccine. In a group of children, samples will be collected both before and after BCG revaccination/no revaccination to measure changes in cytokine profile. Children with a large PPD reaction (> 15mm) will be followed in a similar way as the other children as this may reflect immune stimulation from exposure to natural TB. The studies of morbidity and immunological changes will be done both in the dry and the rainy seasons. The children will be followed for hospitalisations and mortality to 5 years of age.
- Conditions
- Malaria
- Being tested
- Bacille Calmette Guerin (BCG)
- Keywords
- Non-specific effects of vaccines, Infant mortality, Morbidity, Low income country, Malaria, BCG, immunisation, BCG revaccination, Tuberculin, Mortality
- Medical subject headings
- Malaria, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacille Calmette Guerin (BCG)Biological
0,1 ml, revaccination at 19 months of age
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Bacille Calmette Guerin (BCG) |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality till 5 years of age
Hospitalisations till 5 years of age
Adverse effects within 12 months after intervention
Secondary outcomes (4)
Tuberculin reaction 2 months after intervention
Scar reaction 2 months after intervention
Malaria morbidity/parasitaemia within 12 months after intervention
Assessment of antibody and cellular immune responses 18 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startJul 2002
- Primary completionMay 2006
- Study completionSep 2006
Why it stopped: A cluster of deaths in the BCG-arm compared with controls
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- 2,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- International Cooperation with Developing Countries, Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland, Medical Research Council Unit, The Gambia
- Investigators
- Peter Aaby, Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126217
- Sponsor's protocol ID
- ICA4-CT-2002-10053-REVAC
- Other IDs
- EU contract ICA4-CT-2002-10053
- Status last verified
- Oct 2008
- First submitted
- 2 Aug 2005
- Last updated
- 21 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCG Vaccination and Childhood Morbidity and Mortality: Interventions With Possible Implications for the Immunisation Policy in Developing Countries. Revaccination of Young Children With BCG Vaccine.
- ClinicalTrials.gov ID
- NCT00126217
- Acronym / sponsor ID
- ICA4-CT-2002-10053-REVAC
- Conditions
- Malaria
- Keywords
- Non-specific effects of vaccines, Infant mortality, Morbidity, Low income country, Malaria, BCG, immunisation, BCG revaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A cluster of deaths in the BCG-arm compared with controls
- Enrolment
- 2,871 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- International Cooperation with Developing Countries, Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland, Medical Research Council Unit, The Gambia
- Study start
- Jul 2002
- Primary completion
- May 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 3 Aug 2005 (estimated)
- 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.
BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality. The specific objective of the study is to examine the effect of revaccination for purified protein derivative of tuberculin (PPD) reaction, scar size, morbidity and mortality in a randomised prospective study of revaccination versus no revaccination among children 19 months of age in Guinea-Bissau. The hypothesis is that revaccination with BCG reduces childhood mortality after 19 months of age by 30%.
Detailed description
Examine in a randomised trial whether revaccination with BCG reduces childhood mortality after 19 months of age by 30%.
Criteria for verification: 3,000 children aged 1½ year enrolled and followed for an average of 3 years; information on potential adverse events among children with a positive PPD reaction; assessment of parasitaemia after revaccination; assessment of the tuberculin response and scar-formation after revaccination; and assessment of all-cause mortality during the period of follow-up.
Following consent to participate, children will be assessed for BCG scar and tuberculin reaction at 18-19 months of age. Subsequently, the children will be invited to a clinical examination at one of the health centres. The study will be explained again to the mother, and if she accepts to participate, she will draw a randomisation number deciding whether the child will be revaccinated or not. The BCG vaccine given will be the standard dose of 0.1 ml as recommended by WHO in this age group. In the beginning of the study, a group of 800 revaccinated and not revaccinated children will be followed weekly for two months to monitor morbidity and possible adverse effects of the vaccination. It is not expected that Koch like reactions will be common in this age group. However, should there be too many adverse reactions among children with a positive tuberculin test, only tuberculin negative children will be included in the continuation of the trial.
Two months after inclusion, the children will have another tuberculin test to examine changes in tuberculin reaction. At the same time, scar-size will be measured. In the initial phase of the project, a finger-prick blood sample will be collected from 1000 children to examine whether BCG boosting/no boosting have had an effect on the prevalence of malaria parasitaemia and the level of measles antibodies. Children with malaria will be treated and children with non-protective levels of measles antibodies will be offered revaccination with measles vaccine. In a group of children, samples will be collected both before and after BCG revaccination/no revaccination to measure changes in cytokine profile. Children with a large PPD reaction (> 15mm) will be followed in a similar way as the other children as this may reflect immune stimulation from exposure to natural TB. The studies of morbidity and immunological changes will be done both in the dry and the rainy seasons. The children will be followed for hospitalisations and mortality to 5 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Bacille Calmette Guerin (BCG) |
| 2 | No intervention | – |
Who may qualify
- Ages
- 19 to 24 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- No overt illness
Key exclusion criteria (1 listed)
- PPD reaction >15mm
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 |
|---|---|---|
| Bacille Calmette Guerin (BCG)0,1 ml, revaccination at 19 months of age | Biological | 1 |
Primary outcome
Mortality till 5 years of age
Hospitalisations till 5 years of age
Adverse effects within 12 months after intervention
4 secondary outcomes
Tuberculin reaction 2 months after intervention
Scar reaction 2 months after intervention
Malaria morbidity/parasitaemia within 12 months after intervention
Assessment of antibody and cellular immune responses 18 months after intervention
Results and safety
The study was stopped early (reason given: A cluster of deaths in the BCG-arm compared with controls). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
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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.
Peter Aaby principal investigator
Bandim Health Project
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 Bacille Calmette Guerin (BCG) in people with Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Oct 2008. 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 Guinea-Bissau. 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 stopped early (reason given: A cluster of deaths in the BCG-arm compared with controls). Results are not available in the source record.
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?
Mortality till 5 years of age. The study lists 3 primary outcomes in all. 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 21 Oct 2008.