Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategie… (NCT04166656) | Clinical Trial Compass
RecruitingPhase 3
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
France84 participantsStarted 2022-09-15
Plain-language summary
The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.
Who can participate
Age range
18 Years – 75 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
. Male or female, \>=18 to \<=75 years old.
. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
. Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
. Women of childbearing age must have an effective contraception during the first 9 months of the study.
. Participants must give written consent prior to any trial procedure
. Participants must be covered by social security regimen or equivalent.
. Participants will be followed during the 4 years from the inclusion visit.
Exclusion criteria
. History of meningococcal vaccination B.
. History of anaphylaxis post vaccination.
. Known allergy to any components (active substances or excipients) of both vaccines.
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
Proportion of responders defined as participants with seroconversion
Timeframe: One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
. Patients who cannot stop antibiotics 3 days before blood collection.
. Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (except the meningococcal ACWY vaccine, the anti-pneumococcal vaccine, the Haemophilus influenzae type B vaccine, the anti-Covid-19 vaccine), annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
. Parenteral Ig within the 3 months prior to VS or planned during the study.
. Chemotherapy agents within 6 months prior M0 or planning to take any during the study.
. Steroids (\> 10mg/day; \> 14 days) within the month preceding M0 or planning to take any during the study.