A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.
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|ClinicalTrials.gov Identifier: NCT02296983|
Recruitment Status : Unknown
Verified April 2016 by University of Oxford.
Recruitment status was: Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : April 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ebola Virus Disease||Biological: VSV-ZEBOV||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Kilifi, Kenya.|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Low dose arm
The low dose cohort will receive an intramuscular (deltoid) injection of 3x106 pfu of VSV-ZEBOV vaccine.
Other Name: BSPSC1001
Experimental: Full dose arm
The full dose cohort will receive an intramuscular (deltoid) injection1x107 pfu of VSV-ZEBOV vaccine.
Other Name: BSPSC1001
- 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 ]To evaluate the safety and tolerability of two different doses of VSVΔG-ZEBOV vaccine
- Incidence and severity of local and systemic reactogenicity signs and symptoms [ Time Frame: Day 0-28 ]
- Incidence of unsolicited adverse events (AEs) [ Time Frame: Days 0-28 ]
- Incidence of serious adverse events (SAEs) [ Time Frame: Days 0-365 ]
- Distribution of values of safety laboratory measures at baseline and at follow-up visits post-vaccination [ Time Frame: Day 0-30 ]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.
- Persistence of titres of ZEBOV-specific IgG antibodies [ Time Frame: 0-180 days ]
- Detection, magnitude and duration of VSV-ZEBOV viraemia and shedding [ Time Frame: Day 1, 3 and 7 ]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.
- Titres of neutralising ZEBOV-specific IgG antibodies [ Time Frame: Days 7, 30, 60, 90, 180 and 365 ]
- Pattern of ZEBOV specific T cell responses [ Time Frame: Days 7, 30, 90, 180 and 365 ]
- Titers of ZEBOV-specific IgG antibodies [ Time Frame: Days 0-28 ]Important for dose selection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296983
|KEMRI Wellcome Trust Research Programme|
|Kilifi, Coast, Kenya, 80108|
|Principal Investigator:||Philip Bejon, MD, PhD||KEMRI-Wellcome Trust Collaborative Research Program|