BCG InfectionPhase 4BAMNCT02002156
A Study of the Interaction Between BCG And MenC Immunisation: BAM
A Phase 4 study testing BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® and NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® in people with BCG Infection and Reaction - Vaccine, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more effectively to a subsequent infection with TB. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- BCG Infection, Reaction - Vaccine, Immune Response
- What is being tested?
- BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® and NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2014to 27 Jun 2018
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female babies aged 7 days or under
- Born at term (≥ 36 completed weeks of gestation)
- Valid informed consent provided by an individual with parental responsibility (parent or legal guardian)
- Living within the Thames Valley region at enrolment without intention to move out of this region during the course of the study
- Parents or legal guardians must be aged 18 years or over
- Parent or legal guardian is able (in the Investigator's opinion) and willing to comply with all study requirements
- Parent or legal guardian consent provided for General Practitioner and consultant, if appropriate, to be notified of participation in the study
- Parent or legal guardian consent to review hospital birth records before enrolment and inform GP or Consultant of involvement in study, if appropriate
Who cannot join
- Confirmed, suspected or significant risk of immunodeficiency (including but not limited to: maternal history of Human Immunodeficiency Virus infection, family history of congenital or hereditary immunodeficiency and receipt of significant immunosuppressive medication by the participant during the study, or by the mother prior to delivery)
- Receipt of BCG or another live vaccine prior to enrolment
- Receipt of any vaccine, either prior to enrolment or planned during the study, except for:
- those listed in the study protocol at the times indicated
- hepatitis A or B vaccine or influenza vaccine.
- Receipt prior to enrolment, or planned receipt during the study, of monoclonal antibodies, immunoglobulin or any blood product
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- A baby who would normally be offered BCG at birth under current Department of Health guidance3. This means:
- babies living in an area of the UK with an annual incidence of TB >40 / 100,000 or
- babies who have a parent or grandparent who was born in a country with an annual incidence of TB >40 / 100,000
- Confirmed or suspected household contact with active TB
- Confirmed or suspected anaphylaxis to any component of BCG or other study vaccine
- Any confirmed or suspected serious medical condition (including seizures, neurological conditions, major congenital abnormalities or malignancy)
- Receipt of systemic antimicrobial medication since birth
- Parents or legal guardians should not be members of the study team or named on the study delegation log
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the potential participant (or carer) at risk because of participation in the study, or may influence the result of the study, or the potential participant's ability to participate in the study.
- A potential participant who has participated or is participating in another research study involving an investigational product
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Oxford, Oxford Vaccine Group
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Pilot Study of the Impact of BCG Administration on the Immunogenicity of Serogroup C Meningococcal Conjugate Vaccine in Healthy Infants
The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more effectively to a subsequent infection with TB.
Many studies have shown that BCG is effective in reducing deaths from TB disease, particularly in children. However, there is also evidence that in countries with a relatively high death rate, BCG reduces this death rate but by more than would be expected by its effect on TB alone. This controversial but important finding warrants further and serious consideration. One possibility is that BCG, in addition to stimulating the immune system against TB, also has a positive effect on the way the immune system works more generally. This might mean a more effective response to serious infections that are completely unrelated to TB, or the ability to respond better to other routine childhood vaccines, or to maintain such responses for longer. In these examples, the timing of BCG administration in relation to other vaccines could be crucial.
Read more
This study will recruit 30 healthy babies who would not routinely be offered the BCG vaccine in the UK within the first week of life. Babies will be assigned at random to one of three groups of ten babies each. BCG will be given to one group of babies around birth, one at three months old and the last group will not get BCG during the study. Babies will stay in the study until 13 months old and have five blood tests over this period.
This preliminary study will look at the participants' blood to see if there are differences in the immune system, or its response to the MenC childhood meningitis vaccine or the pattern of genes activated after BCG has been given.
- Conditions
- BCG Infection, Reaction - Vaccine, Immune Response
- Being tested
- BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®Biological
Also called BCG vaccine (Serum Statens Institute), NeisVac---C®, Baxter Healthcare Ltd., Pediacel®, Sanofi Pasteur MSD Ltd., Infanrix™---IPV---Hib, GlaxoSmithKline
This group will receive BCG at birth and all routine vaccinations.
BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®Biological
Also called BCG vaccine (Serum Statens Institute), NeisVac---C®, Baxter Healthcare Ltd., Pediacel®, Sanofi Pasteur MSD Ltd., Infanrix™---IPV---Hib, GlaxoSmithKline
This group will receive BCG at three months old and all routine vaccinations.
NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®Biological
Also called NeisVac---C®, Baxter Healthcare Ltd., Pediacel®, Sanofi Pasteur MSD Ltd., Infanrix™---IPV---Hib, GlaxoSmithKline, Prevenar---13®, Pfizer Ltd.
This group will receive no BCG but will receive all routine vaccinations.
| Study group | Role | What they receive |
|---|---|---|
| BCG at birth and routine vaccines | Experimental | BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® Receives: Biological: BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® |
| BCG at 3 months old and routine vaccines | Experimental | BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® Receives: Biological: BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® |
| Routine vaccines | Experimental | NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® Receives: Biological: NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
MenC-specific IgG in blood
Measured: 8 weeks following the dose of MenC vaccine (i.e. at 20 weeks of age if no delay in the schedule)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study start20 Jun 2014
- Primary completionAug 2016
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCG InfectionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002156
- Sponsor's protocol ID
- OVG-2013/04
- Acronym
- BAM
- Status last verified
- Oct 2018
- First submitted
- 19 Nov 2013
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Impact of BCG Administration on the Immunogenicity of Serogroup C Meningococcal Conjugate Vaccine in Healthy Infants
- ClinicalTrials.gov ID
- NCT02002156
- Acronym / sponsor ID
- BAM / OVG-2013/04
- Conditions
- BCG Infection, Reaction - Vaccine, Immune Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 5 Dec 2013 (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.
The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more effectively to a subsequent infection with TB.
Many studies have shown that BCG is effective in reducing deaths from TB disease, particularly in children. However, there is also evidence that in countries with a relatively high death rate, BCG reduces this death rate but by more than would be expected by its effect on TB alone. This controversial but important finding warrants further and serious consideration. One possibility is that BCG, in addition to stimulating the immune system against TB, also has a positive effect on the way the immune system works more generally. This might mean a more effective response to serious infections that are completely unrelated to TB, or the ability to respond better to other routine childhood vaccines, or to maintain such responses for longer. In these examples, the timing of BCG administration in relation to other vaccines could be crucial.
This study will recruit 30 healthy babies who would not routinely be offered the BCG vaccine in the UK within the first week of life. Babies will be assigned at random to one of three groups of ten babies each. BCG will be given to one group of babies around birth, one at three months old and the last group will not get BCG during the study. Babies will stay in the study until 13 months old and have five blood tests over this period.
This preliminary study will look at the participants' blood to see if there are differences in the immune system, or its response to the MenC childhood meningitis vaccine or the pattern of genes activated after BCG has been given.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCG at birth and routine vaccines | Experimental | Biological: BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® |
| BCG at 3 months old and routine vaccines | Experimental | Biological: BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® |
| Routine vaccines | Experimental | Biological: NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy male or female babies aged 7 days or under
- Born at term (≥ 36 completed weeks of gestation)
- Valid informed consent provided by an individual with parental responsibility (parent or legal guardian)
- Living within the Thames Valley region at enrolment without intention to move out of this region during the course of the study
- Parents or legal guardians must be aged 18 years or over
Key exclusion criteria (16 listed)
- Confirmed, suspected or significant risk of immunodeficiency (including but not limited to: maternal history of Human Immunodeficiency Virus infection, family history of congenital or hereditary immunodeficiency and receipt of significant immunosuppressive medication by the participant during the study, or by the mother prior to delivery)
- Receipt of BCG or another live vaccine prior to enrolment
- Receipt of any vaccine, either prior to enrolment or planned during the study, except for:
- Receipt prior to enrolment, or planned receipt during the study, of monoclonal antibodies, immunoglobulin or any blood product
- A baby who would normally be offered BCG at birth under current Department of Health guidance3. This means:
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 |
|---|---|---|
| BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®Also: BCG vaccine (Serum Statens Institute), NeisVac---C®, Baxter Healthcare Ltd., Pediacel®, Sanofi Pasteur MSD Ltd., Infanrix™---IPV---Hib, GlaxoSmithKlineThis group will receive BCG at birth and all routine vaccinations. | Biological | BCG at birth and routine vaccines |
| BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®Also: BCG vaccine (Serum Statens Institute), NeisVac---C®, Baxter Healthcare Ltd., Pediacel®, Sanofi Pasteur MSD Ltd., Infanrix™---IPV---Hib, GlaxoSmithKlineThis group will receive BCG at three months old and all routine vaccinations. | Biological | BCG at 3 months old and routine vaccines |
| NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®Also: NeisVac---C®, Baxter Healthcare Ltd., Pediacel®, Sanofi Pasteur MSD Ltd., Infanrix™---IPV---Hib, GlaxoSmithKline, Prevenar---13®, Pfizer Ltd.This group will receive no BCG but will receive all routine vaccinations. | Biological | Routine vaccines |
Primary outcome
MenC-specific IgG in blood
Time frame: 8 weeks following the dose of MenC vaccine (i.e. at 20 weeks of age if no delay in the schedule)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® and NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix® in people with BCG Infection and Reaction - Vaccine, run by University of Oxford at 1 site in United Kingdom.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 18 Oct 2018. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MenC-specific IgG in blood (time frame: 8 weeks following the dose of MenC vaccine (i.e. at 20 weeks of age if no delay in the schedule)). 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 18 Oct 2018.