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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02296983
Other study ID # OXTREC 71-14
Secondary ID SSC 2976
Status Active, not recruiting
Phase Phase 1
First received November 11, 2014
Last updated April 13, 2016
Start date December 2014
Est. completion date September 2016

Study information

Verified date April 2016
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority Kenya: Pharmacy and Poisons BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities. The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders. There are currently no specific treatments generally available for Ebola and the mortality is high, particularly in countries with limited intensive care facilities. There is currently no vaccine and the personal protection required by healthcare workers treating patients is cumbersome and requires full compliance to be protective.

There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon, Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which this study will be conducted. The investigators are conducting this trial, a Phase I, open-label, dose escalation trial, designed to establish safety, tolerability and immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first time in sub-Saharan African populations.

The investigators plan to vaccinate 40 volunteers in Kenya. The trial will be conducted at the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the primary target population as they are likely to be the recipients of a protective vaccine. The investigators will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the vaccine. The investigators will follow them up for a period of one year looking to their safety and immunogenicity endpoints.


Description:

This study is being conducted to assess safety and immunogenicity of an experimental ebola vaccine.

An outbreak due to the Ebola Zaire (ZEBOV) strain of unprecedented magnitude and scope and with a high mortality continues to spread across West Africa. No vaccine is currently licensed.

The specific opportunity at hand with rVSVΔG-ZEBOV-GP (BPSC1001) is to achieve long-lasting protective immunity to ZEBOV on a time scale of weeks in humans upon a single-shot vaccination, offering a discrete benefit over prime-boost vaccination protocols. The current outbreak represents a global health emergency and the need for access to therapeutic intervention and vaccines is paramount.

The vaccine investigated in this study might provide a critical tool to suppress future out-breaks of EVD in areas at risk.

This study is 1 of 4 clinical trials currently conducted as part of the WHO-led VEBCON consortium, aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001) vaccine candidate to allow optimized rapid decisions on dose and safety.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date September 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
VSV-ZEBOV
VSV-ZEBOV

Locations

Country Name City State
Kenya KEMRI Wellcome Trust Research Programme Kilifi Coast

Sponsors (8)

Lead Sponsor Collaborator
University of Oxford Albert Schweitzer Hospital, Institute of Tropical Medicine, University of Tuebingen, Philipps University Marburg Medical Center, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Geneva, Wellcome Trust, World Health Organization

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary The nature, frequency, and severity of adverse events (AEs) and/or serious adverse events (SAEs) with causal link to the study intervention To evaluate the safety and tolerability of two different doses of VSV?G-ZEBOV vaccine Days 0-30 Yes
Secondary Incidence and severity of local and systemic reactogenicity signs and symptoms Day 0-28 Yes
Secondary Incidence of unsolicited adverse events (AEs) Days 0-28 Yes
Secondary Incidence of serious adverse events (SAEs) Days 0-365 Yes
Secondary Distribution of values of safety laboratory measures at baseline and at follow-up visits post-vaccination The distribution of values of safety laboratory measures will include the assessment of complete blood count (with differential white cell count), creatinine and alanine transaminase levels at baseline and day 7 and 30 following vaccine administration. Day 0-30 Yes
Secondary Persistence of titres of ZEBOV-specific IgG antibodies 0-180 days No
Secondary Detection, magnitude and duration of VSV-ZEBOV viraemia and shedding The detection and concentration (copies/ml) of rVSV (viral shedding) will determined in blood, urine, or saliva samples to evaluate VSV vaccine viraemia following vaccine administration. The duration will be determined by the last timepoint with detectable viraemia.This is a composite measure. Day 1, 3 and 7 Yes
Secondary Titres of neutralising ZEBOV-specific IgG antibodies Days 7, 30, 60, 90, 180 and 365 No
Secondary Pattern of ZEBOV specific T cell responses Days 7, 30, 90, 180 and 365 No
Secondary Titers of ZEBOV-specific IgG antibodies Important for dose selection Days 0-28 No
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