Clinical trial • Phase III • Infectious Disease

RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN; OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B for Asplenia

Phase III trial of RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; RECOMBINANT NE…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Asplenia
Trial Stage
Phase III
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
30-07-2024
First CTIS Authorization Date
09-08-2024

Trial design

Randomised Phase III trial in France.

Randomised
Yes
Target Sample Size
84
Trial Duration For Participant
1460

Eligibility

Recruits 84 Vulnerable population selected; participants must give written consent prior to any trial procedure. Participants are adults (>=18) so assent is not applicable. No further details on vulnerable-population consent handling provided..

Pregnancy Exclusion
Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.
Vulnerable Population
Vulnerable population selected; participants must give written consent prior to any trial procedure. Participants are adults (>=18) so assent is not applicable. No further details on vulnerable-population consent handling provided.

Inclusion criteria

  • {"criterion_text":"- Male or female, >=18 to <=75 years old\n- Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film\n- Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up\n- Women of childbearing age must have an effective contraception during the first 9 months of the study.\n- Participants must give written consent prior to any trial procedure.\n- Participants must be covered by social security regimen or equivalent.\n- Participants will be followed during the 4 years from the inclusion visit."}

Exclusion criteria

  • {"criterion_text":"- History of meningococcal B vaccination.\n- Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.\n- Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.\n- Severe acute febrile illness within the week before inclusion\n- Registration for any other clinical trial throughout the trial period except observational study.\n- History of anaphylaxis post vaccination.\n- Known allergy to any components (active substances or excipients) of both vaccines.\n- Patients who cannot stop antibiotics 3 days before blood collection.\n- 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 (excepted meningocoque ACWY vaccine, pneumococcal vaccine, Haemophilus vaccine, Covid-19 vaccine and 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).\n- Parenteral Ig within the 3 months prior to VS or planned during the study.\n- Chemotherapy agents within 6 months prior M0 or planning to take any during the study.\n- Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study.\n- 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;"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of responders defined as participants with seroconversion (i.e. hSBA titer increases from <4 before vaccination to at least 4) or with hSBA titer showing a 4-fold increase (if hSBA titer was at least 4 before vaccination) one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.","definition_or_measurement_approach":"Responders defined as participants with seroconversion (hSBA titer increases from <4 before vaccination to at least 4) or with hSBA titer showing a 4-fold increase if hSBA titer was ≥4 before vaccination; measured one month after completion of vaccine strategy (at M7 for all arms)."}

Recruitment

Planned Sample Size
84
Recruitment Window Months
72
Consent Approach
Participants must give written consent prior to any trial procedure. An adult informed consent form is indicated (L1_SIS-ICF majeur). No information on assent or pediatric consent documents; languages available are not specified.

Geography

Total Number Of Sites
20
Total Number Of Participants
84

France

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
09-08-2024
Processing Time Days
46
Number Of Sites
20
Number Of Participants
84

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
CIC Hôpital cardiologique
Contact Person Name
Dominique DEPLANQUE
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
CIC 1432 Module Plurithématique et Service de Gastro-entérologie et Hépatologie
Contact Person Name
Lionel PIROTH
Contact Person Email
lionel.piroth@chu-dijon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Centre d'Investigation Clinique
Contact Person Name
Xavier DUVAL
Contact Person Email
xavier.duval@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine Interne
Contact Person Name
Agnès LEFORT
Contact Person Email
agnes.lefort@aphp.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Maladies infectieuses et tropicales – Vaccinations
Contact Person Name
Violaine CORBIN-VALDENAIRE
Contact Person Email
vcorbin@chu-clermontferrand.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Maladies Infectieuses
Contact Person Name
Cécile JANSSEN
Contact Person Email
cjanssen@ch-annecygenevois.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
CIC Vaccinologie Cochin-Pasteur CIC 1417
Contact Person Name
Odile LAUNAY
Contact Person Email
odile.launay@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
CRC et Service des maladies infectieuses Maladies Infectieuses et Tropicales
Contact Person Name
Anne CONRAD
Contact Person Email
anne.conrad@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Maladies infectieuses et tropicales - CIC-CIE3
Contact Person Name
Elisabeth BOTELHO-NEVERS
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Maladies Infectieuses et Tropicales
Contact Person Name
Vincent DUBEE
Contact Person Email
vincent.dubee@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Maladies Infectieuses et Tropicales
Contact Person Name
Jocelyne MICHON
Contact Person Email
michon-j@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Maladies Infectieuses et Tropicales, Centre de Prévention des Maladies Infectieuses & Transmissibles
Contact Person Name
Maeva LEFEBVRE
Contact Person Email
maeva.lefebvre@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Centre d'investigation clinique CIC1406
Contact Person Name
Enkelejda HODAJ
Contact Person Email
ehodaj@chu-grenoble.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Médecine post-urgence – maladies infectieuses
Contact Person Name
Thomas GUIMARD
Contact Person Email
thomas.guimard@chd-vendee.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Unité d'Investigation Clinique CIC 1414- Pôle Santé Publique
Contact Person Name
Fabrice LAINE
Contact Person Email
fabrice.laine@chu-rennes.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Centre d'Investigation Clinique CIC 1409, Centre de néphrologie et de transplantation rénale
Contact Person Name
Bertrand DUSSOL
Contact Person Email
bertrand.dussol@ap-hm.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Centre d'Investigation Clinique CIC-CRB 1404
Contact Person Name
Marie-Pierre TAVOLACCI
Contact Person Email
mp.tavolacci@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Maladies Infectieuses et Tropicales
Contact Person Name
Alain MAKINSON
Contact Person Email
a-makinson@chumontpellier.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Centre d'Investigation Clinique INSERM CIC-1434
Contact Person Name
Catherine MUTTER
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Centre d'Investigation Clinique CIC-P 1412, Service des Maladies Infectieuses et Tropicales
Contact Person Name
Sylvain JAFFUEL
Contact Person Email
sylvain.jaffuel@chu-brest.fr

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Active Substance
RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN; RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN; OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR
Route
INTRAMUSCULAR
Authorisation Status
Authorised
Starting Dose
1 U unit(s)
Dose Levels
1 U unit(s)
Maximum Dose
3 U unit(s)
Investigational Product Name
Trumenba suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant, adsorbed)
Active Substance
NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY A; NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY B
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR
Route
INTRAMUSCULAR
Authorisation Status
Authorised
Starting Dose
1 U unit(s)
Dose Levels
1 U unit(s)
Maximum Dose
3 U unit(s)

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