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

Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococal B Vaccine Strategies Among Patients With Asplenia

Patrocinadores

Patrocinador principal: Assistance Publique - Hôpitaux de Paris

Colaborador: EUCLID Clinical Trial Platform
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
CIC 1417 Cochin Pasteur
Innovative clinical research in vaccinologie (I-REIVAC)
Institut Pasteur

Fuente Assistance Publique - Hôpitaux de Paris
Resumen breve

The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.

Descripción detallada

Currently, in France, no immunogenicity data on Meningococal B vaccines, neither with Bexsero® nor with Trumenba®, are available in asplenic patients, population at high risk of infection.

As asplenic individuals (all causes) show less optimal immune response to conjugate meningococcal C vaccine compared to matched controls. [4], we hypothesize that a similar less optimal response may be expected for MenB vaccines among asplenic subjects. .

That is why, we proposed in this study to evaluate two reinforced strategies with 3 administrations (M0, M1, and M6) of Bexsero® or Trumenba ®. Moreover, the study will also allow exploring the persistence of the immune response in this population. Indeed, few data are available on this persistence in the general population.

Estado general Not yet recruiting
Fecha de inicio February 2020
Fecha de Terminación March 2026
Fecha de finalización primaria February 2026
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Proportion of responders defined as participants with seroconversion One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
Resultado secundario
Medida Periodo de tiempo
Immunogenicity one month after the completeness of each vaccine strategy
Persistence of immunogenicity At M12 M24, M36 and M48
Modeling of the determinants of immunogenicity during the trial
Any event or serious adverse event 7 days following each vaccination.
safety and effectiveness through study completion
Inscripción 84
Condición
Intervención

Tipo de intervención: Biological

Nombre de intervención: Trumenba®

Descripción: Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.

Etiqueta de grupo de brazo: Arm A : Trumenba®: Standard vaccination

Tipo de intervención: Biological

Nombre de intervención: Bexsero®

Descripción: Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe

Elegibilidad

Criterios:

Inclusion Criteria:

1. - Male or female, >=18 to <=75 years old.

2. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film and splenectomy confirmed by ultrasound.

3. Women of childbearing age must have an effective contraception during the first 9 months of the study.

4. Participants must give written consent prior to any trial procedure

5. Participants must be covered by social security regimen or equivalent.

6. Participants will be followed during the 4 years from the inclusion visit.

Exclusion Criteria:

1. History of meningococcal vaccination.

2. History of anaphylaxis post vaccination.

3. Known allergy to any components (active substances or excipients) of both vaccines.

4. Patients who cannot stop antibiotics 7 to 10 days before blood collection.

5. Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 9 months of the study (excepted annual influenza vaccination which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).

6. Parenteral Ig within the 3 months prior to VS or planned during the study.

7. Chemotherapy agents within 6 months prior M0 or planning to take any during the study.

8. Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study.

9. 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;

10. Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.

11. Pregnancy, breastfeeding or positive pregnancy test up to 9 months after inclusion.

12. Severe acute febrile illness within the week before inclusion.

13. Registration for any other clinical trial throughout the trial period except observational study.

Género: All

Edad mínima: 18 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Odile LAUNAY, MD,PhD

Teléfono: +33(01)58 41 28 58

Email: [email protected]

Ubicación
Instalaciones: Contacto: Copia de seguridad de contactos: Investigador: I-REIVAC/CIC1417 Cochin Hospital, AP-HP Odile LAUNAY, MD,PhD +33(01)58 41 28 58 [email protected] Odile LAUNAY, MD, PhD Principal Investigator
Ubicacion Paises

France

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Número de brazos 3
Grupo de brazo

Etiqueta: Arm A : Trumenba®: Standard vaccination

Tipo: Other

Descripción: Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.

Etiqueta: Arm B:Bexsero®: standard vaccination regimen

Tipo: Other

Descripción: Two doses of 0.5 ml each at one month intervals

Etiqueta: Arm C : Bexsero® Innovative vaccine strategy

Tipo: Other

Descripción: Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.

Acrónimo SPLEMENGO
Datos del paciente Undecided
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Prevention

Enmascaramiento: None (Open Label)

Descripción de enmascaramiento: The trial will be open label. However, the assessment of the primary and secondary immunological endpoints will be carried out blind from the treatment arm.

Fuente: ClinicalTrials.gov