A Study of the Interaction Between BCG And MenC Immunisation: BAM (NCT02002156) | Clinical Trial Compass
CompletedPhase 4
A Study of the Interaction Between BCG And MenC Immunisation: BAM
United Kingdom28 participantsStarted 2014-06-20
Plain-language 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.
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.
Who can participate
Age range
7 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MenC-specific IgG in blood
Timeframe: 8 weeks following the dose of MenC vaccine (i.e. at 20 weeks of age if no delay in the schedule)