Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)
Từ khóa
trừu tượng
Sự miêu tả
Ebola virus disease (EVD) in West Africa is spreading rapidly, and there is a critical need for a vaccine to prevent EVD. There are two candidate Ebola virus vaccines, the chimpanzee adenovirus 3 (ChAd3-EBO Z)-based vaccine and the Vesicular Stomatitis virus (VSVdeltaG-ZEBOV)-based vaccine. This study will evaluate both of these vaccines in a randomized, double-blind, controlled, 3-arm study in Liberia. Each vaccine will be compared against the same active control. Because there are limited data on the safety of these vaccines, the initial phase (phase 2) of the study will include the collection of more detailed data on safety and will define the immune response elicited by each vaccine in the first 600 volunteers. With the decline in new cases of Ebola virus infection the phase 3 component was no longer deemed to be feasible and, following safety, ethical and FDA approve/concurrence, the study was amended to a more robust, 1,500 person phase 2 design.
With the amendment to only a phasae 3 study the endpoint reverted to the phase 2 endpoint of safety and immunogenicity.
Participants aged 18 year and older will be enrolled at health clinics in Monrovia, Liberia over 4 months. A single dose of the assigned agent will be administered. Participants in phase 2 will undergo blood draw and assessment of adverse events (AEs) and signs and symptoms of Ebola infection at 1 week and 1 month after vaccination, and monthly assessment of AEs and signs and symptoms of Ebola thereafter. Participants in phase 3 will undergo monthly assessment of AEs and signs and symptoms of Ebola infection after vaccination. All participants will be followed for 8 to 12 months.
This clinical trial to evaluate vaccine efficacy will provide an accurate assessment of the benefits and risks associated with each candidate vaccine and inform policy on wider scale vaccination in other countries.
ngày
Xác minh lần cuối: | 01/31/2020 |
Đệ trình đầu tiên: | 01/21/2015 |
Đăng ký ước tính đã được gửi: | 01/21/2015 |
Đăng lần đầu: | 01/25/2015 |
Cập nhật lần cuối được gửi: | 04/12/2020 |
Cập nhật lần cuối đã đăng: | 04/14/2020 |
Ngày gửi kết quả đầu tiên: | 05/24/2017 |
Ngày gửi kết quả QC đầu tiên: | 05/24/2017 |
Ngày đăng kết quả đầu tiên: | 07/31/2017 |
Ngày bắt đầu nghiên cứu thực tế: | 01/19/2015 |
Ngày hoàn thành chính ước tính: | 05/31/2016 |
Ngày hoàn thành nghiên cứu ước tính: | 05/31/2020 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Biological: 3
Biological: 2
Biological: 1
Giai đoạn
Nhóm cánh tay
Cánh tay | Can thiệp / điều trị |
---|---|
Experimental: 2 ChAd3-EBO Z | Biological: 2 The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion. |
Experimental: 3 VSVG-ZEBOV | Biological: 3 The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV) |
Placebo Comparator: 1 Placebo (Saline) | Biological: 1 |
Đủ tiêu chuẩn
Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
Giới tính đủ điều kiện để nghiên cứu | All |
Chấp nhận tình nguyện viên lành mạnh | Đúng |
Tiêu chí | - INCLUSION CRITERIA: The inclusion criteria for the study are broad reflecting the target population that would eventually receive an efficacious vaccine. - Informed consent - Age greater than or equal to 18 years - Likely to be in the surrounding area of the vaccination center for at least one year. EXCLUSION CRITERIA: - Fever greater than or equal to 38.0 degrees Celsius - History of EVD (self-report) - Current pregnancy (a negative urine pregnancy test is required for women of child-bearing potential) - Breast-feeding an infant - Any condition which would limit the ability of the participant to meet the requirements of the study protocol |
Kết quả
Các biện pháp kết quả chính
1. Serious Adverse Events. [One month]
2. Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody. [One month]