24/06/15

ebola-vaccine-uganda-health-disease

Ebola vaccine
Copyright: PAHO/WHO

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  • In a phase I trial, experts are assessing if RV 422 is safe for use in humans
  • Researchers in Uganda aim to create a vaccine that could prevent Ebola
  • Lessons from the trial could help develop vaccines for Marburg virus

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The continuing Ebola outbreak in West Africa has shown how quickly infectious diseases can have a devastating impact on public health and economy of nations.
 
The Makerere University Walter Reed Project (MUWRP) in Kampala, Uganda is conducting a trial to determine if an Ebola vaccine candidate is safe for use. The enrolment of participants has ended and researchers are now following them up.
 
The intervention, known as RV 422, has two vaccines that were jointly manufactured by Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID) in the United States and UK-headquartered GlaxoSmithKline. One vaccine is being tested against the Ebola Zaire strain while the other vaccine is known to have activity against both Ebola Zaire and Sudan strains. The trial, which is funded by the NIAID, follows a first Ebola vaccine trial conducted by the MUWRP in Uganda from 2009 to 2012.
 
SciDev.Net interviewed Francis Kiweewa, head of research at the MUWRP.
 
Can you tell us what you’re doing?
 
The primary objective is to develop a vaccine candidate that can be used to prevent Ebola, especially in an outbreak setting when people don’t have enough time to prepare and develop immunity. You need a vaccine candidate that you can give quickly to health workers or responders to develop immunity against Ebola so that they can be able to help those who need help. One of the primary objectives really is to have a candidate that can be developed further for prevention of Ebola.
 
But when one tests vaccines we do it in phases, so there’s an early phase and there’s a later phase. What we are doing is phase I trial of a candidate vaccine to determine if the vaccine is safe for use in humans, and also if they elicit an immune response. We are not determining whether the vaccine can prevent Ebola. We are trialling about 90 healthy adults in Uganda.
 

“The primary objective is to develop a vaccine candidate that can be used to prevent Ebola, especially in an outbreak setting when people don’t have enough time to prepare and develop immunity.”

Francis Kiweewa, Makerere University Walter Reed Project (MUWRP)

The trial involves a single injection of RV 422 and participants are followed for 48 weeks. After that we think there will be a lot of data. The plan is to eventually analyse all these and report it to various audiences through publications, presentations or policy engagements or engagement with the manufacturers of the vaccine.
 
What prompted this trial?
 
Uganda has had several outbreaks of Ebola right from 2000 in Gulu, a district in northern Uganda. In 2007 there was another outbreak in Bundibugyo — a town in western Uganda. The MUWRP really has a keen interest in developing vaccines for Ebola and Marburg because we’ve had a number of outbreaks. This specific vaccine is being fast-tracked in part because of the West African outbreak.
 
The trial we are doing in humans is supported by data from animal studies. Based on the data from animal studies we are optimistic this vaccine will proceed to other stages.
 
We have been at the forefront of testing of vaccine candidates. One of our mandates is to try to mitigate disease threats resulting from infectious diseases. We know there are other players in the country, but we’ve been doing this for quite a long time. We are working with a number of government bodies including Uganda’s Ministry of Health and Uganda Virus Research Institute to ensure that we contribute to Uganda government’s effort to fight these diseases. Ebola is just one of them. We do a lot of studies on HIV and influenza.
 
How important is this trial for health in Sub-Saharan Africa?
 
We need to have more advanced phases of clinical trials before we can conclude that the vaccine candidate protects against Ebola. Right now, in this phase I trial, we are just determining whether the vaccine is safe for use. This vaccine right now may not be used in an outbreak setting because further testing needs to be done.
 
How did you attract eligible participants?
 
We advertised through radio. Of course people who come for information go out and talk about it too, so maybe there are more people who came because of that word of mouth.
 
Part of the process for us as researchers was to provide information to people who are interested in participating in our research. They must really understand what is going to happen and that the vaccine does not contain the Ebola virus, whether killed or alive. That’s important really because I think that’s where part of the stigma with Ebola comes from, that the virus is highly infectious.

“The trial we are doing in humans is supported by data from animal studies. Based on the data from animal studies we are optimistic this vaccine will proceed to other stages.”

Francis Kiweewa, Makerere University Walter Reed Project (MUWRP)

We gave eligible participants information about the study to enable them to decide whether they would like to be involved. We then assessed whether they met the inclusion criteria such as being 18-65 years old, and not being a pregnant woman.  We also did a series of investigations to establish that a potential participant is healthy.
 
We received a remarkable response from the community. I think people want to be part of the solution. We’ve had so many outbreaks in Uganda and the recent outbreak in West Africa emphasised the importance of being prepared.

Are there any associated health risks?
 
All drugs come with some side effects. There are some side effects common to vaccines.  For example, the polio vaccine may lead to swelling or fever that usually subsides. We expect such effects to be associated with this vaccine candidate but there are many other safety issues that we are not aware of and that’s why we’re conducting the trial.

Are there lessons in this trial for developing other vaccines?
 
In 2009, we tested two vaccines, one for Ebola virus and one for Marburg virus, in animals. Ebola is closely related to Marburg. One of our objectives was to see if we could develop two vaccines concurrently. We’ve had a number of small Marburg outbreaks, so it’s of interest to develop a vaccine against Marburg too. Hopefully, we can get some lessons in this trial to help develop Marburg vaccines.
 
Q&As are edited for length and clarity.
 
This article has been produced by SciDev.Net's Sub-Saharan Africa desk