202091 (EBOLA Z CHAD3-005)

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201504001092179
• Date of registration: 01/04/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxosSmithKline (GSK)
• Public title: 202091 (EBOLA Z CHAD3-005)
• Scientific title: 202091 (EBOLA Z CHAD3-005)
• Date of first enrolment: 01/05/2015
• Target sample size: 3000
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1092
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,The randomisation will use a minimisation procedure accounting for age (18 - 40 years, 41 to 60 years or >60 years), gender and centre,Central Randomization
• Phase: Not Applicable

Countries of recruitment

Cameroon, Ghana, Mali, Nigeria, Senegal

Contacts

• Name: Sue Bailey
• Affiliation: Director, CLinical Operations

• Name: Guy Vernet
• Affiliation: Principal Investigator

Key inclusion & exclusion 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: 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.

Age minimum: 18 Year(s)
Age maximum: 999 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola
EBOLA

Ebola

Intervention(s)

ChAd3-EBO

ChAd3-EBO-Z

Primary Outcome(s)

Occurrence of any unsolicited local and general AE

Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest)

Occurrence of each solicited 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 any SAE, in all subjects, in both groups

Secondary Outcome(s)

Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay

Source(s) of Monetary Support

GlaxoSmithKline (GSK)

Ethics review

Status: Not approved
Approval date:
Contact:

Comité National d'Ethique de la Recherche pour la Santé Humaine

Status: Not approved
Approval date:
Contact:

Coordonnateur du Comité National d'Ethique de la Recherche en Santé (CNERS)

Status: Not approved
Approval date:
Contact:

Faculty of Medicine & Odontostomatology

Status: Not approved
Approval date:
Contact:

Kintampo Health Research Centre

Status: Not approved
Approval date:
Contact:

NAFDAC

Status: Not approved
Approval date:
Contact:

National Health Research Ethics Committee

Status: Not approved
Approval date:
Contact:

Noguchi Memorial Institute for Medical Research