New vaccine strategy could shield spleenless patients from deadly infection
NCT ID NCT04166656
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing three different ways to give the meningococcal B vaccine to adults who have had their spleen removed. People without a spleen are at higher risk for serious infections. The study will compare how well each vaccine schedule triggers the immune system and how safe they are, with the goal of finding the best protection strategy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trumenba® and Bexsero® (meningococcal B vaccines)
- What this could lead to
- If successful, this could identify the most effective vaccine schedule to protect people without a spleen from a life-threatening meningococcal infection.
- What could go wrong
- This is a relatively small trial (84 participants) and focuses on immune response, not directly on preventing infection. Results may not apply to all asplenic patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female, \>=18 to \<=75 years old. 2. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film 3. Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up 4. Women of childbearing age must have an effective contraception during the first 9 months of the study. 5. Participants must give written consent prior to any trial procedure 6. Participants must be covered by social security regimen or equivalent. 7. Participants will be followed during the 4 years from the inclusion visit. Exclusion Criteria: 1. History of meningococcal vaccination B. 2. History of anaphylaxis post vaccination. 3. Known allergy to any components (active substances or excipients) of both vaccines. 4. Patients who cannot stop antibiotics 3 days before blood collection. 5. 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). 6. Parenteral Ig within the 3 months prior to VS or planned during the study. 7. Chemotherapy agents within 6 months prior M0 or planning to take any during the study. 8. Steroids (\> 10mg/day; \> 14 days) within the month preceding M0 or planning to take any during the study. 9. Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, evolutive cancer, cirrhosis, known infection to HIV; 10. Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections. 11. Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion. 12. Severe acute febrile illness within the week before inclusion. 13. Registration for any other clinical trial throughout the trial period except observational study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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I-REIVAC/CIC1417 Cochin Hospital, AP-HP
RECRUITINGParis, 75014, France
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Other studies related to the condition(s) this trial covers.
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- Blood thinner apixaban tested for late clots after spleen surgery
- New survey aims to boost infection safety for Spleen-Free patients