Who is sponsoring NCT03509051?

NCT03509051 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT03509051?

Interventions in NCT03509051: B vaccination.

What condition does NCT03509051 study?

NCT03509051 studies Hematopoietic Stem Cell Transplant, Meningococcal Vaccine.

Is NCT03509051 still recruiting?

NCT03509051 is currently completed. Last updated 26 October 2020.

Last reviewed 2020-10-26 · How we verify

NCT03509051: MENINGREF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 26 October 2020

What this trial tests

NA trial testing B vaccination in Hematopoietic Stem Cell Transplant in 40 participants. Completed in 13 March 2020.

Timeline

1 June 2019

Primary endpoint
13 March 2020

13 March 2020

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	1 June 2019
Primary completion	13 March 2020
Estimated completion	13 March 2020
Sites	1 location across France

Drugs / interventions tested

B vaccination — full drug profile →

Conditions studied

Hematopoietic Stem Cell Transplant — all drugs for Hematopoietic Stem Cell Transplant →
Meningococcal Vaccine — all drugs for Meningococcal Vaccine →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Hematopoietic Stem Cell Transplant or Meningococcal Vaccine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The 48<sup>th</sup> Annual Meeting of the European Society for Blood and Marrow Transplantation: Physicians - Poster Session (P001 - P578).
· 2022 · cited 4× · PMID 36323940 · DOI 10.1038/s41409-022-01798-0

Verify or expand the search:

Other recruiting trials for Hematopoietic Stem Cell Transplant

Currently open trials in the same condition.

NCT06575712 — Coping Skills Training for Symptom Management and Daily Steps (Step Up) · NA · recruiting
NCT06328127 — Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors · NA · recruiting
NCT06462365 — Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT) · Phase 1 · recruiting
NCT03613532 — Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN · Phase 1 · active not recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03509051 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 26 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03509051.

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