| Protocol No: | ECCT/14/11/01 | Date of Protocol: | 30-10-2014 |
| Study 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.
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| Study Objectives: | To evaluate VSV vaccine viraemia using PCR after administration of VSVG-ZEBOV vaccine. To evaluate the ZEBOV-specific antibody responses induced by VSVΔG-ZEBOV vaccine. To evaluate VSV vaccine viraemia using PCR after administration of VSVG-ZEBOV vaccine. |
| Laymans Summary: |
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.
Lay title: A study to find out if a new Ebola vaccine is safe and may protect adults.
What is the problem/background?
Ebola is a disease that occurs in epidemics. So far it occurs in outbreaks and more than half of the affected people die from the disease. Currently there is an outbreak in West and Central Africa that has affected over 7,000 people with over 3,000 deaths. There is no treatment or vaccine for Ebola. The therapies available currently are still in development and have not been licenced for use in humans. The World Health Organisation together with the vaccine manufacturer have asked a few research centres to be involved in the testing of this vaccine of which we are one centre.
What questions are we trying to answer?
Is this Ebola vaccine safe to give in adults in Kilifi? Does this Ebola vaccine lead to an immune response in adults in Kilifi?
Where is the study taking place, how many people does it involve and how are they selected?
The study will be carried out at the KEMRI –CGMR Coast in Kilifi. We aim to enroll 40 adults (health workers) in this study. They will be volunteers following dissemination talks and those interested will be invited to get further information on the study. They will then make a decision to be included in the study.
What does the study involve for those who are in it?
The volunteers will sign the informed consent to indicate their willingness to be involved in the study. They will undergo a clinical examination and tests to ensure that they are healthy. They will receive one dose of the vaccine and then have 10 follow-up visits over 1 year.
What are the benefits and risks/costs of the study for those involved?
The benefits will be thorough clinical tests which might identify problems not previously identified. There will be some risks from the procedures such as pain and discomfort. There may be a reaction to the vaccine such as fever, pain or general malaise. There may be rare and unexpected risks such as an allergic reaction.
How will the study benefit society?
Should this study prove the vaccine to be safe and show an immune response, it may provide the basis for use in outbreak situation.
When does the study start and finish?
The study will run for 1 year.
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| Abstract of Study: |
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. Although Kenya has not previously experienced outbreaks of Ebola, we are now at particular risk because of Kenya’s role as a hub for international travel. 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. |