NCT04166656 Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
| NCT ID | NCT04166656 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Splenectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 84 participants in total. It began in 2022-09-15 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 3. Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up 4. Women of childbearing age must have an effective contraception during the first 9 months of the study. 5. Participants must give written consent prior to any trial procedure 6. Participants must be covered by social security regimen or equivalent. 7. Participants will be followed during the 4 years from the inclusion visit. Exclusion Criteria: 1. History of meningococcal vaccination B. 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 3 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 7 months of the study (except the meningococcal ACWY vaccine, the anti-pneumococcal vaccine, the Haemophilus influenzae type B vaccine, the anti-Covid-19 vaccine), 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). 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 7 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.
Contact & Investigator
Odile LAUNAY, MD,PhD
PRINCIPAL INVESTIGATOR
CIC 1417 Clinical Center Investigation
Frequently Asked Questions
Who can join the NCT04166656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Splenectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04166656 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 84 participants.
Is NCT04166656 currently recruiting?
Yes, NCT04166656 is actively recruiting participants. Contact the research team at odile.launay@aphp.fr for enrollment information.
Where is the NCT04166656 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04166656 clinical trial?
NCT04166656 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Odile LAUNAY, MD,PhD at CIC 1417 Clinical Center Investigation. The trial plans to enroll 84 participants.