2024-513649-35-00招募中3 期
SPLEMENGO - Multicenter, randomized, phase III, trial assessing the immunogenicity and safety of three meningococal B vaccine strategies among patients with asplenia
Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris18 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年8月9日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 18
- 主要终点
- 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.
研究概览
简要总结
The primary objective of this trial is to assess immunogenicity one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms), in asplenic adults.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female, >=18 to <=75 years old
- •Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
- •Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
- •Women of childbearing age must have an effective contraception during the first 9 months of the study.
- •Participants must give written consent prior to any trial procedure.
- •Participants must be covered by social security regimen or equivalent.
- •Participants will be followed during the 4 years from the inclusion visit.
排除标准
- •History of meningococcal B vaccination.
- •Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.
- •Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.
- •Severe acute febrile illness within the week before inclusion
- •Registration for any other clinical trial throughout the trial period except observational study.
- •History of anaphylaxis post vaccination.
- •Known allergy to any components (active substances or excipients) of both vaccines.
- •Patients who cannot stop antibiotics 3 days before blood collection.
- •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).
- •Parenteral Ig within the 3 months prior to VS or planned during the study.
- •Chemotherapy agents within 6 months prior M0 or planning to take any during the study.
- •Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study.
- •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;
结局指标
主要结局
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.
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.
次要结局
未报告次要终点
研究者
Odile LAUNAY
Scientific
Assistance Publique Hopitaux De Paris
研究点 (18)
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