By Asmau Ahmad
The WHO will on Saturday launch a Phase III trial of “VSV-EBOV” Ebola vaccine in Guinea this will be done in conjunction with Health ministry of Guinea, Médecins Sans Frontières (MSF), Epicentre and The Norwegian Institute of Public Health (NIPH). The move is to test the efficacy and effectiveness of the new vaccine to prevent Ebola. This information is conveyed by a statement issued by the Geneva-based UN agency in New York on Thursday. It said the vaccine was developed by the Public Health Agency of Canada.
It stated that a second vaccine would be tested in a sequential study, as supply becomes available. The statement said that the vaccination would take place in areas of Basse Guinée, the region that currently has the highest number of Ebola cases in the country.
It added that the trial strategy adopted would be “ring vaccination”, based on the approach used to eradicate smallpox in the 1970s. This involves the identification of a newly diagnosed Ebola case, the “index case” and the tracing of all his/her contacts. The contacts are vaccinated if they give their consent.
It said that the objectives of the trial were two-fold: to assess if the vaccine protects the contacts who were vaccinated and if vaccinating the contacts would create a buffer, or ring of protected individuals, around the index case to prevent further spread of the infection.
The statement said the vaccination would also be proposed for frontline workers in the area where the trial will take place. It said that Canadian governmental institutions are supporting the trial through the provision of critical training and support to the African research teams conducting the trial, in addition to scientific advice.
It explained that in the last six months, WHO had convened a series of emergency consultations with scientists, ethicists, regulators and policy makers to identify potential preventive and therapeutic products to help stem the epidemic. It said Canada’s VSV and GSK cAd3 vaccines quickly emerged as promising tools due to prior successful studies on non-human primates.
The statement quotes Dr Margret Chan, WHO Director-General, as saying: “we have worked hard to reach this point.
“There has been massive mobilization on the part of the affected countries and all partners to accelerate the development and availability of proven interventions.
“If a vaccine is found effective, it will be the first preventive tool against Ebola in history.”
Also, Assistant Director-General, Marie-Paul Kieny, who lead the Ebola Research and Development effort at WHO, said: “’the Ebola epidemic shows signs of receding but we cannot let down our guard until we reach zero cases.
“An effective vaccine to control current flare-ups could be the game-changer to finally end this epidemic and an insurance policy for any future ones.” The statement also quoted Bertrand Draguez, Medical Director at MSF, as saying: “for more than a year, we have been racing around the clock to stop the epidemic from spreading further.
“We need to ensure that we continue our efforts to identify infection cases and follow up on their contacts, and in parallel keep promoting research and development for treatments, diagnostics and vaccines.
“This epidemic remains unpredictable. We don’t know when it will end, and that’s why it remains crucial for us to keep focusing our efforts on developing a vaccine capable of protecting the population in this epidemic and any future ones.”
“Frontline workers and the contacts of infected patients will be enrolled, if they consent, in the vaccine study.”
It stated that the ‘VSV-EBOV’ vaccine was selected for the planned trial based on a framework of parameters developed by the WHO Scientific and Technical Advisory Committee on Ebola Experimental interventions (STAC-EE).
The criteria included acceptable safety profile, induction of appropriate immune responses, including neutralizing antibodies, and the timely availability of sufficient supplies of vaccine doses. Further measures were taken to accelerate the testing process by organising multi-country emergency assessments, joint ethical and regulatory reviews of trial protocols and clearing of regulatory hurdles.
For the Guinea trial, the Guinea National Regulatory Authority with support from Health Canada jointly reviewed the trial protocol. It stated that the WHO, UNICEF, U.S. centres for Disease Control (CDC), the Bill and Melinda Gates Foundation and GAVI (the Global Vaccine Alliance), were collaborating with the affected countries to develop plans and strategies for large-scale introduction, should this be needed. It further said the vaccines’ manufacturers have assured that enough vaccine will be available in the coming months. The statement stated that financial resources are in place to procure and make vaccines available to the Ebola affected countries.
Millions of doses will be funded by GAVI, whose Executive Board approved a 300 million dollars funding envelope in December 2014. It said there was also 90 million dollars earmarked to support the deployment of the vaccine (s).
