A Cohort Study to Evaluate the Long-term Safety and Immunogenicity of the Candidate Ebola Vaccines Ad26.ZEBOV and MVA-BN®-Filo in Adults and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 653
- 试验地点
- 2
- 主要终点
- Binding antibody responses against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).
研究概览
简要总结
The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study evaluating the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in participants who were exposed to these vaccines in the VAC52150EBL3001 trial (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494). No investigational vaccine will be administered during this study. The study will consist of an enrolment visit, a number of study visits and an end-of-study visit.
详细描述
The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study to evaluate the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in adults and children.
Ad26.ZEBOV consists of the Janssen Vaccines & Prevention B.V. adenovirus serotype 26 (Ad26) vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant.
MVA-BN®-Filo consists of the Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus.
These candidate Ebola vaccines are being evaluated in phase 1, 2 and 3 clinical studies, in different heterologous prime-boost regimens, in which one study vaccine is used to prime a filovirus-specific immune response and the other study vaccine is used to boost the humoral immune responses. The VAC52150EBL3001 study (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494) taking place in Kambia District, Northern Sierra Leone, is a phase 3 trial with an open-label Stage 1 followed by a randomised double-blind controlled Stage 2. In Stage 1, 43 adults (aged 18 years or older) received Ad26.ZEBOV as prime followed by MVA-BN®-Filo boost vaccination at day 57. In Stage 2, approximately 400 adults and 576 children (aged 1 to 17 years - divided into three age groups; 12 to 17 years, 4 to 11 years, and 1 to 3 years), have been randomised to receive a vaccine regimen of Ad26.ZEBOV as prime and MVA-BN®-Filo as boost at day 57, or control vaccination for both prime and boost vaccination. The control used is a World Health Organisation (WHO)-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine. EBOVAC-Salone Extension has been designed to extend the total follow-up period of participants exposed to the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in the EBOVAC-Salone study, and to follow-up infants conceived by a female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo in EBOVAC-Salone.
STUDY OBJECTIVES
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a participant, or former participant, of the EBOVAC-Salone study, and received Ebola vaccine prime vaccination.
- •or Must be an infant conceived by a female participant of EBOVAC-Salone during the 3-month period following vaccination with Ad26.ZEBOV or the 28 day period following vaccination with MVA-BN®-Filo.
- •Must consent to participate in the EBOVAC-Salone Extension study by signing (or thumbprinting, if illiterate) an ICF, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. If a potential participant cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved in the conduct of the study. If the potential participant is under 18 years of age, they and their parent/guardian will be informed about the study and the parent/guardian will be asked to give consent. Children aged 7 years and older will be asked to give positive assent for their participation in the study and the assent procedure must be witnessed by an adult, literate parent/guardian/third party not involved in the conduct of the study, and documented.
- •Must confirm that he/she will return to the study site for each yearly visit.
排除标准
- •Participants in the EBOVAC-Salone study who were allocated to the control arm receiving the WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine
- •Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study, or unlikely to complete follow up
结局指标
主要结局
Binding antibody responses against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).
时间窗: Up to approximately 5 years in adults and 4 years in children from prime vaccination
Serum Concentration of Antibodies Binding to EBOV GP measured by Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).
Number of Serious Adverse Events in subjects who received an Ebola vaccine prime vaccination in the EBOVAC-Salone trial.
时间窗: Up to approximately 5 years in adults and 4 years in children from prime vaccination
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Serious Adverse Events, in infants conceived by an EBOVAC-Salone trial female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo.
时间窗: From birth to their fifth birthday
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
次要结局
- Neutralising antibody responses directed against EBOV GP as measured by a pseudovirion neutralisation assay (psVNA)(At years 2, 3 and 4 post-prime in children and years 3, 4 and 5 post-prime in adults)
- Effect of previous infection with malaria, determined using validated ELISA and bead based assays, on the persistence of the humoral immune response to vaccination.(Up to approximately 5 years in adults and 4 years in children from prime vaccination)