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

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplant; Meningococcal Vaccine
• Interventions: Biological: B vaccination

• Registration Number: NCT03509051
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Study Start: 2019-06-01
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2020-09
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B vaccination	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Henri-Mondor Hospital; 🇫🇷 Créteil, Val De Marne, France