Investigating the Immune Response to 4CMenB in Infants (NCT02080559) | Clinical Trial Compass
CompletedPhase 4
Investigating the Immune Response to 4CMenB in Infants
United Kingdom187 participantsStarted 2014-07-21
Plain-language summary
This randomised, open-label, single-centre, descriptive study aims to investigate gene expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB and to relate this to vaccine reactions and to immune response.
160 healthy Caucasian infants aged 8-12 weeks (at time of first visit) who have not yet received their routine infant immunisations will be recruited. Participation in the study will be limited to to Caucasian infants (defined as having two Caucasian parents). This is so that baseline variability in gene expression data which is to some degree affected by ethnicity is reduced.
Participants will be randomised to either a 'test' group or 'control' group depending on what 4CMenB schedule they receive, with 80 infants in each.
All participants will receive the usual paediatric immunisations according to the UK national immunisation schedule. In addition, participants in the test groups will receive 4CMenB at 2, 4 and at 12 months while those in the control groups will receive the same vaccine at 5, 7 and 13 months. Blood samples will be taken from each infant at specified time points before and after vaccination to address the objectives of the study.
In addition, oro-pharyneal swabs will be obtained around different vaccination timepoints to investigate the effect of 4CMenB vaccination on the oro-pharyngeal Neisseria microbiome.
Who can participate
Age range
8 Weeks – 12 Weeks
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 infants of two Caucasian parents (self-defined by parent) born between 37 and 42 weeks of gestation aged 8-12 weeks at time of first visit
* Parent or legal guardian willing and able to comply with the requirements of the protocol and have internet access for the duration of the study.
* Parent/legal guardian who have given informed consent for their child's participation in the study
Exclusion Criteria:
* Non-Caucasian infants
* Children of parents who are on the delegation log for this study
* Parent/ legal guardian under the age of 18
* History of invasive meningococcal B disease
* Previous vaccination with meningococcal serogroup B vaccine
* History of being a household contact with a case of confirmed bacterial meningitis
* Prior administration of any vaccine or planned administration of any vaccine not specified in the study protocol, with the exception of Hepatitis B vaccine and Influenza vaccines (which can be given 14 days before or after study vaccines), or BCG (which can be administered 28 days before or after study vaccines)
* Prior or planned receipt of any other investigational vaccine or drug
* Confirmed or suspected immunodeficiency
* A family history of congenital or hereditary immunodeficiency, or maternal HIV
* Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone \>0.5ml/kg/day or intravenous glucocorticoid steroid).
* History of allergy to any component of the vaccine
* Major c…
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
Gene expression in whole blood at 4hr, 24hr, 3d and 7d time points following 4CMenB and routine infant vaccination given at 2, 4 and 12 months.