Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Proportion of responders defined as participants with seroconversion
研究概览
简要总结
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.
详细描述
Currently, in France, no immunogenicity data on Meningococcal 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 vaccination B.
- •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 (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).
- •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;
- •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.
研究组 & 干预措施
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.
干预措施: Trumenba® (Biological)
Arm B:Bexsero®: standard vaccination regimen
Two doses of 0.5 ml each at one month intervals
干预措施: Bexsero® (Biological)
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.
干预措施: Bexsero® (Biological)
结局指标
主要结局
Proportion of responders defined as participants with seroconversion
时间窗: 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
- Persistence of immunogenicity(At M12 M24, M36 and M48)
- Any event or serious adverse event(7 days following each vaccination.)
- Modeling of the determinants of immunogenicity(during the trial)
- safety and effectiveness(through study completion)
- Immunogenicity(one month after the completeness of each vaccine strategy)