Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- To estimate the seroconversion rate for neutralising antibodies against the mpox virus (MPXV) 28 days after administration of an mpox vaccine (MVA-BN or LC16m8)
研究概览
简要总结
The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of a routine mpox vaccination campaign in Kinshasa, Democratic Republic of the Congo (DRC). Participants will be followed up at multiple time points after vaccination in order to assess the kinetics and durability of the immune response by collection of blood samples. It is planned to include approximately 150 participants vaccinated with MVA-BN and 150 participants vaccinated with LC16m8.
详细描述
The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of a routine mpox vaccination campaign in Kinshasa, Democratic Republic of the Congo (DRC). Participants will be followed up at multiple time points after vaccination in order to assess the kinetics and durability of the immune response. It is planned to include approximately 150 participants vaccinated with MVA-BN and 150 participants vaccinated with LC16m8. Participants will be followed up in the clinical trial for a period of 24 months with 6 visits: visit 1 (day 0), visit 2 (day 0 + 28 days), visit 3 (day 0 + 59 days), visit 4 (day 0 + 8 months), visit 5 (day 0 + 16 months) and visit 6 (day 0 + 24 months). The study intervention consists of blood samples. At each visit, 10 mL of blood will be collected, and additional blood samples (20 mL per visit) will be taken from a subgroup of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any person aged 18 years old or over at the time of giving informed consent, of any gender
- •Participant received the MVA-BN or LC16m8 mpox vaccine as part of the national vaccination campaign
- •Participant has the capacity and willingness to give informed written consent
- •Participant agrees to adhere to the study's follow-up schedule
排除标准
- 未提供
研究组 & 干预措施
MVA-BN or LC16m8 vaccinated
Participants vaccinated with MVA-BN or LC16m8 vaccine during the national vaccination campaign
干预措施: blood sample collection (Procedure)
结局指标
主要结局
To estimate the seroconversion rate for neutralising antibodies against the mpox virus (MPXV) 28 days after administration of an mpox vaccine (MVA-BN or LC16m8)
时间窗: Day 28 after inclusion
Seroconversion 28 days after administration of an mpox vaccine, defined as the appearance of an MPXV neutralizing antibody titer (NT50) greater than or equal to the limit of detection in participants who were seronegative at baseline, or at least a two-fold increase in the antibody titer compared to baseline (Day 0) in participants who were seropositive at inclusion
次要结局
- To estimate the positivity rate for neutralizing antibodies against MPXV 59 days and 8 months after administration of an mpox vaccine (MVA-BN or LC16m8).(Day 59 and Month 8)
- To analyze the longitudinal evolution of neutralizing antibody titers against MPXV between Day 0, Day 28, Day 59, and Month 8 after administration of an mpox vaccine (MVA-BN or LC16m8).(Day 0, Day 28, Day 59 and Month 8)
- To estimate the positivity rate for binding antibodies (IgG) against MPXV at all sampling time points: Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8).(Day 0, Day 28, Day 59, Month 8, Month 16 and Month 24)
- To analyze the longitudinal evolution of binding antibody (IgG) titers against MPXV between Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8).(Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24)
- To identify factors associated with weak immune responses, measured by the seroconversion rate of neutralizing antibodies at Day 0, Day 28, Day 59, and Month 8 after administration of an mpox vaccine (MVA-BN or LC16m8).(Day 0, Day 28, Day 59, and Month 8)
- To identify factors associated with weak immune responses, measured by the seroconversion rate of binding antibodies (IgG) at Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24 after administration of an mpox vaccine (MVA-BN or LC16m8).(Day 0, Day 28, Day 59, Month 8, Month 16, and Month 24)
- To evaluate the tolerability of MVA-BN and LC16m8 vaccines in terms of solicited symptoms occurring up to 28 days after vaccination.(Day 28)
- To document post-vaccination mpox virus infections after administration of an mpox vaccine (MVA-BN or LC16m8).(Month 24)