A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02485301
• Date of registration: 18/06/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
• Scientific title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Adults in Africa
• Date of first enrolment: July 2015
• Target sample size: 3024
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02485301
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Cameroon, Mali, Nigeria, Senegal

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Virus Diseases

Intervention(s)

Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)

Drug: Placebo

Primary Outcome(s)

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Month 12]

Occurrence of any SAE, in all subjects, in both groups [Time Frame: From Day 0 to study end at Month 24]

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Month 6 + 30 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.]

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Month 6 + 6 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Screening (Day 0)]

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Month 30]

Occurrence of each solicited local and general AE [Time Frame: Up to Day 7 after each vaccination (i.e. the day of vaccination and 6 subsequent days), in a sub cohort of 750 subjects per group.]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Day 3]

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Day 3]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Day 6]

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Day 6]

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Month 6]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Day 30]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Month 12]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Month 6 + 6 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Month 6]

Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest) [Time Frame: Up to Day 7 after vaccination at Day 0 (i.e. Day 0 up to Day 6).]

Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) [Time Frame: At Month 6 + 30 days in a sub cohort of 750 subjects in the Group Placebo/ EBO-Z.]

Occurrence of any unsolicited AE [Time Frame: Up to Day 30 after each vaccination (i.e. the day of vaccination and 29 subsequent days), in a sub-cohort of 750 subjects per group.]

Occurrence of biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [Time Frame: At Screening (Day 0)]

Secondary Outcome(s)

Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA) [Time Frame: At Day 0 and Day 30, in a sub-cohort of 750 subjects per group. At Month 6 and Month 6 + 30 days, in a sub-cohort of 750 subjects in the Group Placebo/ EBO-Z.]

Secondary ID(s)

202091

Source(s) of Monetary Support

Please refer to primary and secondary sponsors