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

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ClinicalTrials.gov Identifier: NCT04166656
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : May 12, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Splenectomy Biological: Trumenba® Biological: Bexsero® Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococal B Vaccine Strategies Among Patients With Asplenia
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Arm A : Trumenba®: Standard vaccination
Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.
 Biological: Trumenba®
Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.
Arm B:Bexsero®: standard vaccination regimen
Two doses of 0.5 ml each at one month intervals
 Biological: Bexsero®
Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe
Arm C : Bexsero® Innovative vaccine strategy
Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.
 Biological: Bexsero®
Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of responders defined as participants with seroconversion [ Time Frame: One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults. ]
    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.


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: one month after the completeness of each vaccine strategy ]

    Immunogenicity at M2/M7, i.e. one month after the completeness of each vaccine strategy:

    • Serum bactericidal antibody (hSBA) Geometric Mean Titer (GMT).
    • Proportion of responding participants using the conservative threshold of 8.
    • Proportion of participants achieving an hSBA titer equal to or greater than the lower limit of quantification of the assay.

  2. Persistence of immunogenicity [ Time Frame: At M12 M24, M36 and M48 ]

    Persistence of immunogenicity at M12 M24, M36 and M48 for each vaccine strategy

    • Serum bactericidal antibody (hSBA), GMT.
    • Proportion of responding participants using the conservative threshold of 8.
    • Proportion of participants achieving an SBA titre equal to or greater than the lower limit of quantification of the assay.

  3. Modeling of the determinants of immunogenicity [ Time Frame: during the trial ]
    Modeling of the determinants of immunogenicity: reason for splenectomy, age, gender, immunosuppressive or immunomodulatory agent

  4. Any event or serious adverse event [ Time Frame: 7 days following each vaccination. ]
    Any event or serious adverse event during the trial possibly or not related to vaccine immunization.

  5. safety and effectiveness [ Time Frame: through study completion ]
    To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166656


Contacts
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Contact: Odile LAUNAY, MD,PhD +33(01)58 41 28 58 odile.launay@aphp.fr
Contact: Audrey BECLIN-CLABAUX +33 (0)1 58 41 33 82 audrey.clabaux@aphp.fr

Locations
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France
I-REIVAC/CIC1417 Cochin Hospital, AP-HP
Paris, France, 75014
Contact: Odile LAUNAY, MD,PhD    +33(01)58 41 28 58    odile.launay@aphp.fr   
Contact: Mouna Fellague Chebra, project manager    +33 (0)1 58 41 33 54    mouna.fellaguechebra@aphp.fr   
Principal Investigator: Odile LAUNAY, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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
Investigators
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Principal Investigator: Odile LAUNAY, MD,PhD CIC 1417 Clinical Center Investigation
Study Director: MUHAMED-KHEIR TAHA, MD, PHD Institut Pasteur
More Information
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Publications:
5. Hcsp. Avis du hcsp relatif à l'utilisation du vaccin bexsero® (novartis vaccines and diagnostics). 2013. (link:http://www.hcsp.fr/explore.cgi/telecharger?nomfichier=hcspa20131025_vaccmeningocoquebbexsero®.pdf.

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04166656    
Other Study ID Numbers: P170938J
2019-000924-17 ( EudraCT Number )
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Meningococcal B vaccine
vaccine strategies
splenectomized individuals