Ebola EBOLA
Conditions
Interventions
ChAd3-EBO
Sponsors
GlaxosSmithKline (GSK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy ALL the following criteria at study entry: ¿ 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. (Amended 17 February 2015.) ¿ A male or female aged 18 years of age or older at the time of Screening. (Amended 17 February 2015.) ¿ 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. Please refer to the glossary of terms for the definition of menarche and 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
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. Refer to APPENDIX C for acceptable limits for eligibility determination. ¿ 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of each solicited local and general AE ;Occurrence of any unsolicited local and general AE ;Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatine) laboratory abnormalities in a sub-cohort group;Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest);Occurrence of any SAE, in all subjects, in both groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay | — |
Countries
Cameroon, Ghana, Mali, Nigeria, Senegal
Contacts
Public ContactSue Bailey
Director, CLinical Operations
Outcome results
None listed