FAQs about the clinical trial

11. How are the volunteers selected?

Dr. Alain Matthey, Physician at the Clinical Research Unit at HUG:
"So that no time is wasted, we screen candidate volunteers by order of arrival. Of course, they have to meet the requirements of the research protocol: they must be at least 18 years old, in good health, etc. Each week, priority is given to people who are planning to travel to areas currently affected by the epidemic."

Prof. Bernard Hirschel, President of the Cantonal Commission of Research Ethics (Geneva):
"In the volunteer selection process, it is important that the first people to be potentially protected against Ebola virus should be those who will be travelling to West Africa to fight the epidemic."

Prof. Claire-Anne Siegrist, Principal Investigator and Head of the Vaccinology Centre at HUG:
"The Phase I clinical trial will involve over one hundred volunteers, who will each come to the hospital ten times: this represents one thousand medical appointments. For Phase II, i.e. the deployment and testing of the vaccine in the field, other scientific teams will take over. Of course, we will provide them with all our clinical data."

12. How often will the vaccinations take place? 

Provided we get enough volunteers, 15 people can be vaccinated every week. The total vaccination period for the 115 volunteers is therefore around 7-8 weeks. As the clinical trial was interrupted between 10 December 2014 and 4 January 2015, the last volunteers should be vaccinated at the end of January 2015.

13. When (and how) will we know if the VSV-ZEBOV vaccine works?

To be really sure that the vaccine protects against the Ebola virus, it will be necessary to examine to what extent people who are both vaccinated and exposed to the virus resist infection.
In the meantime, this clinical trial aims at establishing two important things:
1) the side effects caused by the vaccination: the vaccine is not expected to cause major side effects that would put people at risk, but it is important to know how many vaccinated volunteers will have some fever or flu-like symptoms, and for how long after vaccination. This information will be very useful to distinguish between what is induced by the vaccine and what is not;
2) the extent and duration of the volunteers' immune response: the vaccine should trigger the production of antibodies against the Ebola virus. It is hoped that these antibodies will prove protective when they are exposed to the virus.

Today, we do not know what the best dose is,which has the best tolerance profile, nor which is the most effective. Determining the best dose is the overarching goal of this study.

14. If the results are conclusive, will we need further clinical studies before implementing large-scale vaccination?

It will be necessary to proceed step by step. Phase I clinical trials with the VSV-Ebola vaccine are taking place at the HUG, but also in the United States, Germany, Gabon and Kenya, totaling around 250 volunteers. The clinical trial at HUG involves the largest set of volunteers (115). WHO is already planning phase II and III clinical trials, partly in areas affected by the epidemic, to collect data on vaccine safety on thousands of individuals, and also – hopefully – to protect frontline medical workers who are the most exposed to the epidemic.
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15. How much shorter is this process compared to the study of a conventional vaccine?

The objective is to do in a few months what normally takes between 2 and 4 years, while respecting international standards of quality and safety.

Prof. Claire-Anne Siegrist, Principal Investigator and Head of Vaccinology Centre of HUG:
"Our vaccination protocol has 250 pages and is fully up to standard. Normally, it would have taken a year to prepare it. In this case it was done in one month, by a team of ten people working day and night."

Prof. Bernard Hirschel, President of the Cantonal Commission of Research Ethics (Geneva) and HIV specialist:
"Upon receipt of a research protocol by the Ethics Commission, legislation gives us 30 days to render our decision on a clinical trial of this nature. Given the urgency of the situation, a special session was scheduled and the decision was made in only three days."

16. How many volunteers will receive a placebo? 

This number will vary depending on the profile of the volunteers: placebos will not be given to people who already know that they will visit areas affected by the epidemic.

Prof. Claire-Anne Siegrist, Principal Investigator and Head of Vaccinology Centre of HUG:
"Several close colleagues have volunteered for this vaccination trial. There is a strong sense of being able to do something for our colleagues who are on the front line of the epidemic, and who are facing very difficult situations."

17. Has anyone already received this vaccine? 

In 2009, a person working in the lab was accidentally injured with a needle containing the Ebola virus, and was injected with a preliminary version of the VSV-Ebola vaccine to counter a possible infection. She did not develop the disease, but we do not know whether this was because of the vaccine or because the virus dose was too low.

Two clinical phase I trials each involving 39 volunteers began in mid-October 2014 at the Walter Reed Army Institute of Research Military Hospital (USA) and at the National Institute of Allergy and Infectious Diseases NIAID (USA). Although the final results are not yet available (the Government of Canada also provided free vaccine doses for these trials), to date, no major side-effects have been observed.

18. What do we know already about the VSV-Ebola vaccine?

Prof. Jules Desmeules, Head of the Clinical Investigation Unit of the Clinical Research Centre: "The vaccine manufacturer has provided us with all the information available on the preclinical data related to the toxicology of this vaccine. No toxicity has been observed in the organs of animals that received the vaccine. The potential side effects of the VSV vaccine are minor. In some cases, it is expected that volunteers will have a mild fever for up to 2 days. But I would almost say that this is " expected", because in vaccinating, we are trying to stimulate the immune system: and a slight fever can be a good indicator of such a stimulation. In addition, this vaccine does contain any additives: the risk of allergic reaction is therefore very low. Nevertheless, the Clinical Research Centre is equipped for reanimation and manages all its Phase I clinical trials in coordination with the Intensive Care Unit headed by Prof. Jérôme Pugin."

Prof. Claire-Anne Siegrist, Principal Investigator and Head of Vaccinology Centre of HUG: "There would be no reason to engage in such a clinical trial if we were not fully convinced that the vaccine may be effective and safe."

Prof. Bernard Hirschel, President of the Cantonal Commission of Research Ethics (Geneva) and HIV specialist: "The ethical requirements for clinical studies on vaccines are very high, because we are vaccinating people who are in good health. And we cannot accept a study that would put in danger a person who is in good health."

19. Are the HUG in contact with the other teams that are testing this vaccine?

Yes. Testing of the VSV-ZEBOV vaccine is coordinated by WHO. A consortium bringing together the principal investigators of the 4 clinical centres (Geneva, Hamburg, Lambaréné, Kilifi) has been created. These investigators have pooled their research protocols and will exchange data and information throughout the study period.

Prof. Jules Desmeules, Head of the Clinical Investigation Unit of the Clinical Research Centre:
"The results of the first clinical trials, that are already taking place on 78 volunteers in the USA, will be sent to all teams conducting trials with the same vaccine. There is an international convention (Good Clinical Practice) which states that the sponsor of a clinical trial must be informed within 24 hours in case of serious adverse effects. Information channels and timely communication protocols are strictly defined."

Prof. Claire-Anne Siegrist, Principal Investigator and Head of Vaccinology Centre of HUG:
"The people involved in these clinical trials are keen to gather enough scientific data to be able to roll out a vaccine as soon as possible during 2015. One positive aspect in this race against Ebola is the mobilization of people who are doing far more than what is normally expected and who are willing to share information rather than keeping it for themselves."

20. Will it be possible to modify the research protocol during the course of the clinical trial?

Yes. For example, it is possible to modify the doses used if we find out that a dose is too low or, on the contrary, if it causes too many adverse effects. Each research protocol includes specific rules and allows suspension of the trial in order to analyse what is happening and then decide whether to continue, modify or stop the process. That is what happened for this trial in December 2014: the observation of joint inflammation triggered by the vaccine led to the interruption of the trial and to its re-start on 5 January 2015 with a dose of 300,000 vaccine particles instead of 10 or 50 million.

Prof. Jules Desmeules, Head of the Clinical Investigation Unit of the Clinical Research Centre:
" Each year, Swissmedic manages thousands of modifications on authorized protocols. It makes sense to be able to adapt a protocol to ensure the safety of the people involved in the clinical trial."

21. Have the HUG already performed this type of clinical trial?

Prof. Jules Desmeules, Head of the Clinical Investigation Unit of the Clinical Research Centre:
"Yes, of course. This study is the third phase I clinical trial that we operated in 2014. In 2013, the Clinical Research Centre was involved in over 70 clinical trials (phases I-II-III). This trial has the support of several professional teams and is taking place under optimal conditions, with all necessary measures to ensure the safety of the volunteers."

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Dernière mise à jour : 29/01/2019