Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
ID04166656

Multicenter, Randomized Phase III Trial Assessing Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies in Asplenic Patients

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20

84

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

E

EUCLID Clinical Trial Platform

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the immune response and tolerance of three different vaccine strategies against meningococcus B in adults with asplenia, a condition where the spleen is absent or not functioning. Asplenic patients are at high risk for this serious infection, and data on how well meningococcal B vaccines work in this group are currently lacking. The study also explores how long the immune response lasts in these patients, as little is known about this in the general population. Participants will receive one of three vaccine schedules involving either Trumenba4 or Bexsero4 vaccines. Two schedules include three doses administered at months 0, 1, and 6, while one schedule involves two doses given one month apart. Vaccines are given by intramuscular injection. The study compares these different strategies to assess which provides the best immune response and safety profile. During the study, participants will be followed for four years to monitor their immune response and safety. Blood samples will be collected to measure antibody levels one month after completing vaccinations and at several points up to 48 months. Researchers will also record any adverse events within a week after each vaccination and track overall safety and vaccine effectiveness throughout the study. The main measurement is the proportion of participants who develop a strong immune response one month after the full vaccine course.

CONDITIONS

Brief Title

Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 75 years
  • Asplenic patient for at least 2 weeks with Howell Jolly bodies visible on blood film
  • Splenectomy confirmed by consultation, hospitalization report, or ultrasound
  • Women of childbearing age must use effective contraception during the first 9 months of the study
  • Written consent given before any trial procedure
  • Covered by social security or equivalent
  • Willing to be followed for 4 years from inclusion visit
Not Eligible

You will not qualify if you...

  • History of meningococcal B vaccination
  • History of anaphylaxis after vaccination
  • Known allergy to any vaccine components
  • Unable to stop antibiotics 3 days before blood collection
  • Received other vaccines within 4 weeks prior to immunization or planning vaccines within 7 months (with some exceptions)
  • Parenteral immunoglobulin within 3 months prior or planned during study
  • Chemotherapy within 6 months before study or planned during study
  • Steroid use over 10mg/day for more than 14 days within 1 month before study or planned during study
  • Conditions impairing immune response other than asplenia
  • Blood clotting problems preventing intramuscular injections
  • Pregnancy, breastfeeding, or positive pregnancy test during study period
  • Severe acute fever within 1 week before inclusion
  • Enrolled in other clinical trials except observational studies during this trial period

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 to 7 months

Participants receive meningococcal B vaccine according to one of three strategies involving two or three doses over several months.

3 vaccination visits over 6 months and 1 follow-up visit at 7 months

Follow-up

Duration - Up to 4 years

Participants are monitored for persistence of immune response and safety for up to 4 years after vaccination.

Visits at 12, 24, 36, and 48 months after last vaccination

Trial Site Locations

Total: 1 location

1

I-REIVAC/CIC1417 Cochin Hospital, AP-HP

Paris, France, 75014

Actively Recruiting

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Research Team

O

Odile LAUNAY, MD,PhD

A

Audrey BECLIN-CLABAUX

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage.

Giacomo Frosi, Alessia Biolchi, Morena Lo Sapio...

https://pubmed.ncbi.nlm.nih.gov/23954380

Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis.

Ellen Murphy, Lubomira Andrew, Kwok-Leung Lee...

https://pubmed.ncbi.nlm.nih.gov/19534597

Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age.

Fiona McQuaid, Matthew D Snape, Tessa M John...

https://pubmed.ncbi.nlm.nih.gov/24722351