Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

Study Overview
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Brief Summary
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The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.

Official Title
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A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE

Conditions
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Meningococcal Vaccine

Intervention / Treatment
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* Biological: Trumenba


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants ≥10 years of age at the time of consent. Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies. Negative urine pregnancy test for all female participants. Exclusion Criteria: Previous vaccination with any meningococcal serogroup B vaccine. Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae. Significant neurological disorder or history of seizure (excluding simple febrile seizure). Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. Any confirmed or suspected human immunodeficiency virus infection. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment. Current chronic use of systemic antibiotics. Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab). Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Bivalent recombinant lipoprotein 2086 vaccine | Biological: Trumenba<br>* Bivalent recombinant lipoprotein 2086 vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The percentage of participants with serum bactericidal assay using human complement (hSBA) titer ≥ lower limit of quantitation (LLOQ) for each of the 4 primary Neisseria meningitidis serogroup B (MnB) test strains. | Describe the immune response induced by 2 doses of Trumenba in immunocompromised participants and historical age-matched healthy participants | 1 month after Vaccination 2 in immunocompromised participants compared to historical age-matched healthy participants separately | 
| 2. Percentage of participants reporting local reactions within 7 days after each vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 7 days after each vaccination. | 
| 3. Percentage of participants reporting systemic events within 7 days after each vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 7 days after each vaccination. | 
| 4. Percentage of participants reporting use of antipyretic medication within 7 days after each vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 7 days after each vaccination. | 
| 5. Percentage of participants with at least 1 adverse event (AE) occurring 30 Days after each vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 30 Days after each vaccination | 
| 6. Percentage of participants with at least 1 AE occurring 30 Days after any vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 30 Days after any vaccination | 
| 7. Percentage of participants with at least 1 AE occurring during the vaccination phase. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2) | 
| 8. Percentage of participants with at least 1 immediate AE after each vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Throughout the study (from the time of vaccination administration until 30 minutes post vaccine administration) | 
| 9. Percentage of participants with at least 1 serious AE (SAE) within 30 Days after each vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 30 Days after each vaccination | 
| 10. Percentage of participants with at least 1 SAE within 30 Days after any vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 30 Days after any vaccination | 
| 11. Percentage of participants with at least 1 SAE during the vaccination phase. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2) | 
| 12. Percentage of participants with at least 1 SAE during the follow-up phase. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the follow-up phase (from 1 month after Vaccination 2 through 6 months after Vaccination 2) | 
| 13. Percentage of participants with at least 1 SAE throughout the study. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Throughout the study (from Vaccination 1 through 6 months after Vaccination 2) | 
| 14. Percentage of participants with at least 1 medically attended AE (MAE) within 30 Days after each vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 30 Days after each vaccination | 
| 15. Percentage of participants with at least 1 MAE within 30 Days after any vaccination. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Within 30 Days after any vaccination. | 
| 16. Percentage of participants with at least 1 MAE during the vaccination phase. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2) | 
| 17. Percentage of participants with at least 1 MAE during the follow-up phase. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the follow-up phase (from 1 month after Vaccination 2 through 6 months after Vaccination 2) | 
| 18. Percentage of participants with at least 1 MAE throughout the study. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Throughout the study (from Vaccination 1 through 6 months after Vaccination 2) | 
| 19. Percentage of participants with at least 1 newly diagnosed chronic medical condition (NDCMC) during the vaccination phase. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2) | 
| 20. Percentage of participants with at least 1 NDCMC during the follow-up phase. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the follow-up phase (from 1 month after Vaccination 2 through 6 months after Vaccination 2) | 
| 21. Percentage of participants with at least 1 NDCMC throughout the study. | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | Throughout the study (from Vaccination 1 through 6 months after Vaccination 2) | 
| 22. Number of days participants missed school or work because of AEs during the vaccination phase | Evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants. | During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal Vaccine, Meningitis Vaccine, Asplenia, Sickle cell anemia, Complement deficiencies