A series of safety trials for a potential Ebola virus vaccine that has claimed more than 1,400 people in the West Africa alone could be set to start as early as September with healthy volunteers from the UK, Gambia and Mali.
This project is set to be conducted in phases with trials of the first phase just awaiting ethical and regulatory approval to kick off. The vaccine is against the Zaire species of Ebola circulating in West Africa which uses a single Ebola virus protein to generate immune response in individuals.
At the weekend, Senegal’s health minister confirmed a first case of Ebola, making it the fifth West African country to be affected by the outbreak after Liberia, Sierra Leone, Nigeria and Guinea.
Despite the fact that the volunteers are more than ready, Ebola, like many plagues, have the propensity to claim the public heroes who go out to risk their lives to fight it. Over time, many medics and volunteers in the fight against Ebola have succumbed to the deadly virus leaving their nationals in shock.
Experts perish in the line of duty
In 2000, Dr Matthew Lukwiya, of Lachor Hospital in Uganda, succumbed to Ebola after dedicating his entire life to save hundreds in one of the early struggles against the disease in East Africa.
He would during the subsequent outbreak of Ebola be followed to the heroes’ wall by Dr Jonah Kule with his four assistant health workers from Bundibubugyo. Recently, Dr Sammuel Mutooro from Kasese in western Uganda, who was on a team of medical experts from Uganda, was buried in Liberia.
The medic would soon be joined by Dr Abraham Borbor from Liberia’s biggest hospital in Monrovia, two weeks ago, despite receiving the experimental drug Zmapp. All these deaths have sprung criticism in the public eyes about the experimental drugs
But Adrian Hill, a professor and director of the Jenner Institute at the University of Oxford, is optimistic that this candidate vaccine may prove useful against Ebola adding that:
“The tragic events unfolding in Africa demand an urgent response. In recent years, similar investigational vaccines have safely immunized infants and adults against a range of diseases including malaria, HIV and Hepatitis C,” he said.
Although clinical research by the National Institute of Health (NIH) and Okarios, a biotechnology company acquired by GSK, last year, provides promising protection in non human primates exposed to Ebola without significant adverse effects, safety trials with small groups of individuals would be required to ensure that the vaccine does not cause side effects and that it generates a good immune response to Ebola in humans before it can be rolled out to larger at risk populations, even on experimental basis.
ZMapp has been dubbed the “secret serum” as it is still in the experimental stages of drug development with, until now, no public data on effectiveness.
Doctors have turned to it as there is no cure for Ebola, which has killed more than 1,500 people since it started in Guinea.
At the weekend, researchers said the only clinical trial data on the experimental Ebola drug ZMapp shows it is 100 per cent effective in monkey studies, even in later stages of the infection.
The Oxford study will involve 60 healthy volunteers and if the it shows a good response with no adverse reactions, the trial will after approval extend to volunteers in Gambia and Mali each with 40 volunteers.
Each set of volunteers will be split into groups of 20 that will receive different doses of the vaccine so that researchers can evaluate the best dose to use for both safety and activity.
Umberto D’Alessandro, director of Medical Research Council unit in The Gambia, said there is proven capacity and expertise to carry out trials to the highest quality standards including trials for vaccines similar to this one.
“The proposed trial won’t benefit immediately those currently at risk but we hope that in a not too distant future we may be able to protect people against Ebola,” he said.
Moncef Slaoui, Chairman of Global Research & Development and vaccines at GSK, said developing a new vaccine is complex with no guarantees of success and it’s still early days for our Ebola vaccine candidate,” says, while encouraging doing the be.
Despite this investment being expensive, health experts are determined to proceed with the plans and sources for the funds are already established.
Source of the funding
A consortium funding is to enable GSK, to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, and if trials are successful, stocks then be available immediately by GSK to the World Health Organisation to create an emergency immunization programme for high risk communities.
A $3.5 million grant by the, Wellcome Trust, MRC, and the Department for International development will facilitate a team led by Adrian Hill to start the safety tests of the vaccine alongside similar trials run by the National Institute of Allergy and Infectious Disease.
“We are co-funding these important clinical trials to find a safe vaccine for Ebola as well as providing critical care on the ground,” says Justine Greening, the DFID Secretary.
These tests are highly expected to yield acceptable results; in fact the Oxford Jenner institute has extensive experience in clinical trials, of similar vaccines which have been evaluated clinically for six other diseases in Europe and Africa.