Regulation of Mucosal Immune Response to Systemic MenB Vaccine (NCT00774384) | Clinical Trial Compass
CompletedPhase 2
Regulation of Mucosal Immune Response to Systemic MenB Vaccine
United Kingdom9 participantsStarted 2009-09
Plain-language summary
Meningitis or septicaemia (blood poisoning) caused by group B meningococcal infection (MenB) is an important cause of death and disability in the UK. Prevention through vaccination therefore remains a key public health priority. Research from national "meningitis" vaccine programmes against MenC, Hib and Streptococcus pneumoniae show us that their success is in part due to their ability to protect both the vaccinated and the unvaccinated, so-called herd immunity. This protection probably occurs by reducing carriage of these meningitis bacteria in the back of the throat (mucosal immunity). How this happens is poorly understood but our research shows that naturally acquired immunity (transient contact between the immune system and the meningococcus in the back of the throat without causing disease) may impact on this process. We believe that to develop a MenB vaccine that is able to cause mucosal immunity and prevent MenB carriage, it is important to understand the interaction between natural immunity and vaccination. In this study we propose to administer MenB vaccine to adults in order to investigate this process. Our findings will provide important insights into Men B immunity, inform the design of novel vaccine strategies and allow the rational testing of new vaccines as they become available.
Who can participate
Age range
16 Years – 40 Years
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:
* written informed consent and agreement for samples to be sent overseas
* adults and adolescents 16-40 years scheduled to undergo routine tonsillectomy
* in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator
* availability for all the visits scheduled in the study
Exclusion Criteria:
* tonsillectomy for allergic conditions
* receipt of or intent to immunize with any vaccination (other than influenza vaccine or post-exposure tetanus vaccination) or investigational agents within 50 days prior to enrolment and throughout the study period
* previous receipt of any MenB vaccine
* chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs (Inhaled and topical steroids will not be allowed.)
* history of confirmed or suspected meningococcal infection or close contact with an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days
* pregnancy (or plans to become pregnant during study)\* or breast feeding
* not taking or unwilling to take sufficient measures to avoid pregnancy occurring for the duration of the study period\*\*
* any chronic or progressive disease (eg neoplasm, cardiac, respiratory, liver, gastrointestinal, renal, neurological disease, autoimmune disease, blood dyscrasias or diathesis) or history of dependence/abuse of drugs or alcohol • any confirmed or suspected immu…
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
T-cell proliferation following vaccination and its regulation.
Timeframe: After 2 or 3 doses of vaccine
Trial details
NCT IDNCT00774384
SponsorUniversity Hospitals Bristol and Weston NHS Foundation Trust