Understanding the Immune Response to Two Different Meningitis Vaccines (NCT01593514) | Clinical Trial Compass
CompletedPhase 4
Understanding the Immune Response to Two Different Meningitis Vaccines
United Kingdom20 participantsStarted 2012-12
Plain-language summary
The bacterium (germ) Neisseria meningitidis causes meningitis and blood poisoning. N meningitidis is classified into different serogroups (types), based on its outer polysaccharide (carbohydrate) capsule. Serogroups A,B,C,W \& Y are responsible for the vast majority of meningococcal disease worldwide.
Older vaccines against types A,C,W \& Y contain part of the polysaccharide capsule of the germ. However, these polysaccharide vaccines do not provide long-term protection against disease and are less effective in young children, the group most at risk of meningococcal disease. Newer "conjugate" ACWY vaccines attach a polysaccharide to a protein carrier - these provoke a good response in young children and can provide long-term protection.
White blood cells called B cells produce antibodies, which are the main components of protection against meningococcal disease. Although many studies have investigated the immune response to these vaccines in different age groups by measuring specific antibodies, there is limited information about the B cells underlying such an immune response. Several different subsets (populations) of B cells exist in the blood. Previous studies by the investigators group suggest that different numbers of B cells are produced in response to each vaccine type. However, little is understood about which subset of B cell is important for antibody production in response to these polysaccharide or conjugate vaccines.
This study aims to provide detailed information on the immune response to meningococcal vaccines by investigating the appearance of B cells and their subsets in the blood after vaccination with the polysaccharide and conjugate vaccines. These observations will help us understand how polysaccharide and conjugate vaccines stimulate the immune system in different ways. This knowledge will help in the development of new vaccines that are effective across all age groups.
The investigators aim to recruit 20 adults aged 30-70 from Oxfordshire. The study will be funded by the Oxford Vaccine Group.
Who can participate
Age range
30 Years – 70 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:
Participants must meet the following conditions in order to be enrolled:
* Between 30 and 70 years of age inclusive;
* Willing and able to give informed consent for participation after the nature of the study has been explained;
* In good health as determined by:
medical history history-directed physical examination clinical judgment of the investigator
* Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study;
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
Participants with any of the following conditions or characteristics will be excluded from study enrolment:
* Prior receipt of a meningococcal vaccine;
* Prior laboratory confirmed disease caused by N meningitides;
* Prior history of any anaphylactic shock, asthma, urticarial or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
* Known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
* Receipt of immunostimulants
* Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding year or long-term systemic corticosteroid therapy (prednisolone or equivalent for more than two consecutive weeks within t…
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
phenotype of meningococcal serogroup A specific B cells