Prospective Study on the Vaccine Response to Meningococcal B Vaccine After Allogeneic Stem Cell Transplantation (MENINGREF)

October 23, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Allogeneic hematopoietic stem cell transplant (HSCT) recipients are at risk of various bacterial infections, especially due to a progressive decrease of specific antibodies. Around 90% of HSCT recipients have unprotective titers of specific antibodies to serogroups A and C meningogocci (Parkkali 2001; Mahler 2012).

Some small studies suggest that the response to meningococcal A and C vaccines is close to 100% after 3 doses given 18 months after transplant. Although the response to 2 doses of 4CMenB is over 75% in other immunocompromised patients (Feavers, 2017), studies with 4CMenB are lacking after HSCT. Nevertheless, as serogroup B caused 74% of IMD in Europe between 2004-2014 (Whittaker, 2017), the meningococcal B vaccination is recommended by the more recent guidelines from 6 months after transplant. There are, however, no data on the safety and efficacy of this vaccine after hematopoietic stem cell allograft (HSCT).

The objective of this study is to assess the response to 2 doses of a multicomponent meningococcal B vaccine (4CMenB) given at 2 months interval in adult allogeneic HSCT recipients transplanted at least 6 months ago.

The response will be assessed 1 month and 10 months after the second dose of vaccine by measuring bactericidal antibodies against NadA, fHbp, NHBA and PorAP1 vaccinal antigens according to methods previously reported (Caron Lancet Infect Dis 2011). The response rate will be correlated to pre- and post-transplant factors.

The hypothesis of this study is that 80% of the patients should have protective titers one month after the 2nd dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Monocentric study. Forty patients are expected.

Primary objective: Response rate one month after 2 doses of vaccine

Secondary objectives: safety, rate of protection before vaccination, comparison of the antibody titers at one month vs. at 10 months after the vaccine program. Relationship between pre and post-transplant factors.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val De Marne
      • Créteil, Val De Marne, France, 94000
        • Henri-Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Allogeneic HSCT at least 6 months before
  • Age ≥ 18 years
  • Platelet count > 50 G/L

Exclusion Criteria:

  • Rituximab administration in the previous 6 months
  • Relapse of the underlying disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B vaccination
One intramuscular injection of Bexsero (multicomponent B vaccine) from 6 months after transplant. A second similar dose will be given 2 months later.
Biological: B vaccination
One intramuscular injection of Bexsero (multicomponent B vaccine) from 6 months after transplant. A second similar dose will be given 2 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with Bactericidal titers > 4 to at least one component of the Bexsero vaccine, 1 month after the 2nd dose.
Time Frame: 1 month
Vaccine response rate at one month after the 2nd dose.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with Bactericidal titers > 4 to at least one component of the Bexsero vaccine, 12 months after the 1st dose.
Time Frame: 12 month
Vaccine response rate at 12 month after the 1st dose.
12 month
Number of adverse events of vaccination by Bexsero after Allograft of CSH.
Time Frame: 12 month
Number of adverse events (non serious and serious) reported during the study
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Christine Robin, MD, Assistance publique des Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K180302J

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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