Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,024
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Events of Specific Interest (AESI)
研究概览
简要总结
The purpose of this study is to assess the safety and immunogenicity of the investigational ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in the study will receive the investigational ChAd3-EBO-Z vaccine. The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study, whereas the subjects in the Group Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the investigational ChAd3-EBO-Z vaccine at Month 6, provided that no safety concerns are raised. In addition, vaccinating all subjects in the study with the investigational ChAd3 EBO Z vaccine will allow an increase of the safety database of the investigational vaccine. In case the geographic range of Ebola virus Zaire (EBOV) transmission expands to encompass any of the regions where this trial is conducted, earlier administration of the investigational ChAd3-EBO-Z vaccine to the subjects in the Group Placebo/ EBO-Z will be considered in that region.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Subjects who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. capability of or availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period).
- •Written/ thumb printed informed consent obtained from the subject prior to performing any study specific procedure or written/ thumb printed informed consent obtained from the subject's parent(s)/ legally acceptable representative(s) (LAR[s]) and written/ thumb printed informed assent obtained from the subject, for minor subjects. This will only be applicable for countries where the legal age of majority is ≥ 21 years.
- •A male or female aged 18 years of age or older at the time of Screening.
- •Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to the Day 0 visit, and
- •has a negative pregnancy test at the Day 0 visit, and
- •has agreed to continue adequate contraception until 30 days after the Month 6 visit.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
- •Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine.
- •Known prior EBOV or SUDV disease.
- •Travel to a country affected by the EBOV epidemic or direct contact with a person with EVD within 21 days prior to the Day 0 visit.
- •History of any reaction or hypersensitivity (such as anaphylaxis, urticaria [hives], respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit.
- •Serious acute or chronic illness determined by medical history and clinical examination including, but not limited to:
- •Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome [AIDS]).
- •Any clinically significant haematological (CBC, including differential count and platelet count) or biochemical (ALT, creatinine) laboratory abnormality.
- •Any chronic illness with recent signs of exacerbation, or imposing a change in the chronic treatment regimen, within 3 months prior to the Day 0 visit.
- •Any unstable chronic medical condition (e.g. uncontrolled asthma).
- •Pregnant female.
研究组 & 干预措施
Group EBO-Z
The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study
干预措施: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) (Biological)
Group Placebo/ EBO-Z
The subjects in the Group Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the investigational ChAd3-EBO-Z vaccine at Month 6
干预措施: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) (Biological)
Group Placebo/ EBO-Z
The subjects in the Group Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the investigational ChAd3-EBO-Z vaccine at Month 6
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events of Specific Interest (AESI)
时间窗: During the 7-Day (Days 0-6) post-vaccination period
AESI included clinical symptoms of thrombocytopenia.
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: During the entire study period (up to Month 12)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Unsolicited Adverse Events (AEs)
时间窗: During the 30-Day (Days 0-29) post-vaccination period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Percentage of Subjects With Haematological Laboratory Abnormalities
时间窗: At Month 12
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities
时间窗: At Month 12
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Number of Subjects With Solicited Local Adverse Events
时间窗: During the 7-Day (Days 0-6) post-vaccination period
Assessed solicited local adverse events were pain, redness and swelling. Any = occurrence of any solicited local adverse event regardless of their intensity grade. Grade 3 Pain = significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site.
Number of Subjects With Solicited General Adverse Events
时间窗: During the 7-Day (Days 0-6) post-vaccination period
Assessed solicited general adverse events were fatigue, fever \[defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)\], gastrointestinal (gastro) adverse events \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination. Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities. Grade 3 fever = fever ≥ 39.5 °C. Related = adverse event assessed by the investigator as related to the vaccination.
次要结局
- Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies(At Day 0, Day 30, Month 6 and Month 12)
- Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)(At Day 0, Day 30, Month 6 and Month 12)