New Ebola vaccine 100% effective in human trial conducted in Guinea, says WHO
An experimental Ebola vaccine has been found to be 100 percent affective against the deadly virus in a major human trial in Guinea, giving doctors a safe and potent weapon against any future outbreak, WHO said on Friday.
Geneva: An experimental Ebola vaccine has been found to be 100 percent affective against the deadly virus in a major human trial in Guinea, giving doctors a safe and potent weapon against any future outbreak, WHO said on Friday.
The vaccine is the first to prevent infection from one of the most lethal known pathogens, and the findings add weight to early trial results published last year.
The vaccine, called rVSV-ZEBOV, was studied in a trial involving 11,841 people in Guinea last year. Among the 5,837 people who received the vaccine, no Ebola cases were recorded 10 days or more after vaccination, according to the results published in The Lancet journal.
In comparison, there were 23 cases 10 days or more after vaccination among those who did not receive the vaccine.
The trial was led by the World Health Organisation (WHO), together with Guinea's Ministry of Health and other international partners.
"While these compelling results come too late for those who lost their lives during West Africa's Ebola epidemic, they show that when the next Ebola outbreak hits, we will not be defenceless," said Dr Marie-Paule Kieny, WHO's Assistant Director-General for Health Systems and Innovation, and the study's lead author.
Since Ebola virus was first identified in 1976, sporadic outbreaks have been reported in Africa. However, the 2013–2016 West African Ebola outbreak, which resulted in more than 11, 300 deaths, highlighted the need for a vaccine, WHO said.
The trial took place in the coastal region of Basse-Guinee, the area of Guinea still experiencing new Ebola cases when the trial started last year.
The trial used an innovative design, a so-called "ring vaccination" approach — the same method used to eradicate small pox.
When a new Ebola case was diagnosed, the research team traced all people who may have been in contact with that case within the previous three weeks, such as people who lived in the same household, were visited by the patient, or were in close contact with the patient, their clothes or linen, as well as certain "contacts of contacts".
A total of 117 clusters (or "rings") were identified, each made up of an average of 80 people.
Initially, rings were randomised to receive the vaccine either immediately or after a three-week delay, and only adults over 18 years were offered the vaccine.
After interim results were published showing the vaccine's efficacy, all rings were offered the vaccine immediately and the trial was also opened to children older than six years.
The vaccine's manufacturer, Merck, Sharpe and Dohme, this year received Breakthrough Therapy Designation from the US Food and Drug Administration and PRIME status from the European Medicines Agency, enabling faster regulatory review of the vaccine once it is submitted.
In addition to showing high efficacy among those vaccinated, the trial also shows that unvaccinated people in the rings were indirectly protected from Ebola virus through the ring vaccination approach (so called "herd immunity").
To assess safety, people who received the vaccine were observed for 30 minutes after vaccination, and at repeated home visits up to 12 weeks later, WHO said.
About half reported mild symptoms soon after vaccination, including headache, fatigue and muscle pain but recovered within days without long-term effects.
Two serious adverse events were judged to be related to vaccination (a febrile reaction and one anaphylaxis) and one was judged to be possibly related (influenza-like illness). All three recovered without any long term effects.
It was not possible to collect biological samples from people who received the vaccine in order to analyse their immune response.
Other studies are looking at the immune response to the vaccine including one conducted in parallel to the ring trial among frontline Ebola workers in Guinea.
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