NCT02485301 - A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults | Crick

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Number of Subjects With Solicited Local Adverse Events

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.

Time frame: During the 7-Day (Days 0-6) post-vaccination period

Number of Subjects With Solicited General Adverse Events

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.

Time frame: During the 7-Day (Days 0-6) post-vaccination period

Number of Subjects With Unsolicited Adverse Events (AEs)

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.

Time frame: During the 30-Day (Days 0-29) post-vaccination period

Percentage of Subjects With Haematological Laboratory Abnormalities

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.

Time frame: At Screening

Percentage of Subjects With Haematological Laboratory Abnormalities

Time frame: At Day 3

Percentage of Subjects With Haematological Laboratory Abnormalities

Time frame: At Day 6

Percentage of Subjects With Haematological Laboratory Abnormalities

Time frame: At Day 30

Percentage of Subjects With Haematological Laboratory Abnormalities

Time frame: At Month 6

Percentage of Subjects With Haematological Laboratory Abnormalities

Time frame: At Month 6 + 6 Days

Percentage of Subjects With Haematological Laboratory Abnormalities

Time frame: At Month 6 + 30 Days

Percentage of Subjects With Haematological Laboratory Abnormalities

Time frame: At Month 12