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New vaccine strategy could shield spleenless patients from deadly infection

NCT ID NCT04166656

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • I-REIVAC/CIC1417 Cochin Hospital, AP-HP

    RECRUITING

    Paris, 75014, France

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