A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2016
• Main ID: NCT02296983
• Date of registration: 11/11/2014
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.
• Scientific title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSV?G-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya.
• Date of first enrolment: December 2014
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02296983
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Kenya

Contacts

• Name: Philip Bejon, MD, PhD
• Affiliation: KEMRI-Wellcome Trust Collaborative Research Program

Key inclusion & exclusion criteria

Inclusion Criteria:

- • Have provided written informed consent prior to screening procedures (i.e.
participants must be literate).

- Healthy adult male or non-pregnant, non-lactating female, ages 18 to 55
(inclusive) at the time of screening

- Free of clinically significant health problems, as determined by pertinent
medical history, clinical examination and blood tests at screening

- Available, able, and willing to participate for all study visits and procedures

- Negative pregnancy-test for female volunteers

- Females, of non-childbearing potential who are post-menopausal (i.e. = one year
without menses) or surgically sterilized (tubal ligation, bilateral
oophorectomy, or hysterectomy)

- Females, of childbearing potential, who are willing to use effective methods of
contraception for 14 days before vaccination and 30 days after vaccination.

- Males who are willing to use effective contraception following vaccination for a
period of one week.

- Be willing to minimize blood and body fluid exposure of others for 5 days after
vaccination

Exclusion Criteria:

- • History of severe local or systemic reactions to any vaccination or a history of
severe allergic reactions.

- Known allergy to the components of the BPSC1001 vaccine product

- Unable or unwilling to stay in the study area for the period of the study and
comply with study procedures.

- Ongoing participation in another clinical trial

- Receipt of licensed vaccines within 14 days of planned study immunization (30
days for live vaccines)

- Acute or chronic, clinically significant psychiatric, hematologic, pulmonary,
cardiovascular, or hepatic or renal functional abnormality as determined by the
investigator based on medical history, physical exam, and/or laboratory
screening test

- Any serologic evidence of hepatitis B SAg or HIV infection.

- Any confirmed or suspected immunosuppressive or immunodeficient condition,
cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes

- Have an active malignancy or history of metastatic or hematologic malignancy

- Suspected or known alcohol and/or illicit drug abuse within the past 5 years

- Moderate or severe illness and/or fever >38°C within 2 weeks prior to
vaccination

- Pregnant or lactating woman or a woman who intends to become pregnant within 30
days following vaccination.

- Administration of immunoglobulins and/or any blood products within the 120 days
preceding study entry or planned administration during the study period

- Administration of chronic (defined as more than 14 days) immunosuppressant's or
other immune modifying drugs within 6 months of study entry

- Any other significant finding that in the opinion of the investigator would
increase the risk of the individual having an adverse outcome from participating
in this study



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola Virus Disease

Intervention(s)

Biological: VSV-ZEBOV

Primary Outcome(s)

The nature, frequency, and severity of adverse events (AEs) and/or serious adverse events (SAEs) with causal link to the study intervention [Time Frame: Days 0-30]

Secondary Outcome(s)

Distribution of values of safety laboratory measures at baseline and at follow-up visits post-vaccination [Time Frame: Day 0-30]

Incidence of unsolicited adverse events (AEs) [Time Frame: Days 0-28]

Persistence of titres of ZEBOV-specific IgG antibodies [Time Frame: 0-180 days]

Titres of neutralising ZEBOV-specific IgG antibodies [Time Frame: Days 7, 30, 60, 90, 180 and 365]

Titers of ZEBOV-specific IgG antibodies [Time Frame: Days 0-28]

Incidence of serious adverse events (SAEs) [Time Frame: Days 0-365]

Incidence and severity of local and systemic reactogenicity signs and symptoms [Time Frame: Day 0-28]

Detection, magnitude and duration of VSV-ZEBOV viraemia and shedding [Time Frame: Day 1, 3 and 7]

Pattern of ZEBOV specific T cell responses [Time Frame: Days 7, 30, 90, 180 and 365]

Secondary ID(s)

OXTREC 71-14

SSC 2976

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Geneva

Institute of Tropical Medicine, University of Tuebingen

Universitätsklinikum Hamburg-Eppendorf

Albert Schweitzer Hospital

Wellcome Trust

Philipps University Marburg Medical Center

World Health Organization