A Phase 2, Open-label, Study to Evaluate the Safety and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV, MVA-BN-Filo in Adults and Children Originally Enrolled in the Control Arm of the EBOVAC-Salone Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
研究概览
简要总结
This is a Phase 2, open-label, study evaluating the safety and immunogenicity of the 2-dose vaccination regimen, Ad26.ZEBOV, MVA-BN-Filo, in adults and children originally enrolled in the control arm of the EBOVAC-Salone study
详细描述
This study is being conducted to assess the safety and immunogenicity of the Ad26.ZEBOV (Dose 1), MVA-BN-Filo (Dose 2) vaccine regimen, administered with a 56-day interval between the two doses, in adults and children previously enrolled in the control arm of the VAC52150EBL3001 (EBOVAC-Salone) study.
The heterologous, 2-dose Ebola vaccine regimen is comprised of the following 2 Ebola vaccines:
- Ad26.ZEBOV - an adenovirus serotype 26 vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant
- MVA-BN-Filo - a Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus (SUDV) and Marburg virus (MARV) and the nucleoprotein of Tai Forest virus
STUDY OBJECTIVES AND HYPOTHESIS
Primary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have been enrolled in the control arm and received at least the first vaccination (Dose 1) in EBOVAC-Salone.
- •Must consent to participate, or their parent/guardian must consent for their child to participate, in the VAC52150EBL2012 study.Children aged 7 years and older will be asked to give positive assent for their participation in the study.
- •Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol, or the parent/guardian must be willing/able to ensure that their child adheres to the prohibitions and restrictions specified in the protocol
- •Must be healthy in the investigator's clinical judgement (and the parent/guardian's judgement) on the basis of medical history, physical examination, vital signs, and a haematological assessment (i.e., full blood count) performed at screening.
- •Female subjects of childbearing potential, who have started their menstrual periods and/or are ≥12 years of age at the time of screening must use adequate birth control measures consistent with local regulations regarding the use of birth control for subjects participating in clinical studies from at least 14 days before vaccination until the end of the study, with a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test at screening and immediately prior to the vaccination, which shall occur no earlier than 14 days after the screening visit.
- •Must be willing to participate for the duration of the study visits, or the parent/guardian must be available and willing to have their child participate for the duration of the study visits.
- •Must have, or the parent/guardian must have, the means to be contacted.
- •Must pass the Test of Understanding (TOU), or the parent/guardian must pass the TOU.
排除标准
- •Participants in the EBOVAC-Salone trial who received at least 1 dose of the Ebola vaccine regimen.
- •Subjects who have received any candidate or other Ebola vaccine.
- •Subjects who have a known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccine, e.g., polysorbate 80, ethylenediaminetetraacetic acid, or L-histidine for Ad26.ZEBOV vaccine), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin).
- •Subjects who have a known history of any thrombotic disorder, thrombocytopaenia, thrombotic thrombocytopaenia syndrome (TTS), or heparin-induced thrombocytopaenia and thrombosis (HITT).
- •Subjects with presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38° C on Day
- •Participants with such symptoms will be excluded from enrolment at that time but may be rescheduled for enrolment at a later date within the screening window.
- •Subjects with a clinically significant history of skin disorder (e.g., psoriasis, contact dermatitis), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the investigator or other delegated individual.
- •Women who are known to be pregnant or planning to become pregnant while enrolled in the study.
- •Subjects who have received a blood transfusion or other blood products within 8 weeks prior to vaccination day.
- •Subjects who have been vaccinated with live-attenuated vaccines within 30 days before the study vaccination, or with an inactivated vaccine within 15 days before the study vaccination.
- •Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the vaccination and observation.
- •Subjects with any other finding which, in the opinion of the investigator or other delegated individual, would increase the risk of an adverse outcome from participation in the study.
研究组 & 干预措施
Study Intervention
Subjects will receive the following study vaccines as a 0.5 mL IM injection into the deltoid:
- Ad26.ZEBOV at a dose of 5x10^10 vp on Day 1
- MVA-BN-Filo at a dose of 1x10^8 Inf U on Day 57
干预措施: Ad26.ZEBOV, MVA-BN-Filo (Drug)
结局指标
主要结局
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
时间窗: At Day 78 (21 days post-Dose 2 vaccination)
Proportion of participants with detectable EBOV-specific T cell subsets of interest
Incidence of solicited adverse events in children aged 4-11 years.
时间窗: From the day of Dose 2 vaccination (Day 56 days post-Dose 1) to 7 days post-Dose 2 vaccination
Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically
Incidence of unsolicited serious adverse events
时间窗: From the day of Dose 1 vaccination through 28 days post-Dose 2 vaccination (approximately 84 days)
Number and percentage of participants with any untoward medical event
次要结局
- Vaccine induced humoral immune responses to EBOV GP(At Day 1 (Dose 1 vaccination), Day 57 (56 days post-Dose 1 vaccination), and Day 78 (21 days post-Dose 2 vaccination))