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Tuesday, February 03, 2015

Ebola Vaccine Trial Gets Under Way

Impeccable timing, just as MI6 threatens the world with weaponised Ebola and frightens populations in at-risk countries into subjecting themselves to an unknown, untested "vaccine" that could contain anything - including live virus - thereby spreading the now-pandemic into uncontrolled, uncontainable proportions  

THE IRISH TIMES
02/02/2015

The world’s first large-scale Ebola vaccine trial gets under way in Liberia today.


Over 8,500 people have died from the disease in recent months in West Africa. It is hoped that 30,000 people will participate in the immunisation programme.

The vaccine, co-developed by the National Institutes of Health in the United States and Okairos, a biotechnology firm acquired by GSK in 2013, was first tested in five small phase-one safety trials in Britain, the United States, Switzerland and Mali involving around 200 healthy volunteers in total.


The vaccine uses a type of chimpanzee cold virus to deliver safe genetic material from the Zaire strain of Ebola, the strain responsible for the unprecedented West African epidemic.

Data so far show “an acceptable safety profile” including in a West African population and across a range of dose levels, GSK said, adding it had now selected the most appropriate dosage for the Liberia trial.




Ebola had killed 8,810 people out of 22,092 cases as of January 25th, with the vast majority of deaths and cases in Liberia, Sierra Leone and Guinea, according to the United Nations’ World Health Organisation.


Ebola outbreak has not been completely contained
As the outbreak begins to dwindle, scientists are looking beyond the endgame at the kind of next-generation vaccines needed for a vital stockpile to hit another epidemic hard and fast.

Determined not to lose scientific momentum that could make the world’s first effective Ebola interventions a reality, researchers say the shots, as well as being proven to work, must be cheap, easy to handle in Africa and able to hit multiple virus strains.


That may mean shifting focus from the stripped-down, fast-tracked vaccine development ideas that have dominated the past six months, but it mustn’t mean the field gets bogged down in complexities.

“We need a stockpile because there will be other outbreaks,” said Seth Berkley, chief executive of the GAVI global immunisation alliance, which helps bulk-buy vaccines for poor countries.

The experimental vaccines now moving into large clinical trials in West Africa target the current Ebola Zaire virus strain, but the next outbreak may be different.




“We need to work with the pharmaceutical industry to create second-generation vaccines that would cover not just Ebola Zaire but also Ebola Sudan and perhaps Marburg, perhaps Lassa. The idea is to have vaccines that will work across different places,” Berkley said.

Right now, scientists are grappling with several tricky issues - partly due to success in cutting new infections in the vast Ebola outbreak.




With relatively few new cases, big trials in Liberia and Sierra Leone to test the first generation single-dose one strain vaccines may not have the statistical power needed to show whether the shots work.

And already, early data from safety trials in humans suggest a single-dose vaccination with the most advanced vaccine, from GlaxoSmithKline, may not provoke an immune response strong enough to protect people exposed to the virus.




“We now know you get around 10 times fewer antibodies in humans (than in monkeys) and probably five times fewer T-cells,” said Adrian Hill of Oxford’s Jenner Institute, referring to two key elements of the immune system.

This strongly suggests that a two-dose regime, or a so-called “prime-boost” approach, is the one likely to prove effective, Hill said.

These and other issues add up to a sizeable to do list for scientists focussing on vaccines for future stockpiles.


Test subjects need to bear in mind the results of previous
"clinical trials" of vaccines
Producing multi-strain, or multivalent, vaccines that could protect against different types of Ebola and other haemorrhagic fevers will be more time consuming than making today’s monovalent shots, but it is by no means impossible.



In fact, several of the candidate Ebola vaccines being fast-tracked through testing started out as multivalents before being stripped back to deal with the current outbreak.

Another challenge is ensuring vaccines have a long shelf-life and can be easily transported in the tropics. At the moment, test shots are kept at -70 or -80 degrees Celsius, although Johnson & Johnson says its Ebola vaccine can be stored at normal fridge temperature for many weeks.




Producing adequate volumes, however, looks manageable. Hopefully, the next time Ebola emerges from Africa’s forests it will be spotted earlier and immunisation will be needed for perhaps tens of thousands of people -- nothing like the tens of millions who would need vaccines in a worldwide flu pandemic.


Above all, NEVER TRUST THE CDC
Finally companies still need a regulatory green light, which gets tricky if large-scale trials fail to produce clear proof that the shots are both safe and effective in people.

Researchers and drugmakers say, however, that regulators have made clear stockpile Ebola vaccines could be approved on efficacy data from tests in monkeys or other non-human primates plus proof of safety and immune response in humans, reflecting contingency plans for vaccines designed for bioterror attacks.




Pursuing tomorrow’s vaccines is not to say one of today’s monovalent shots from GSK, Merck or J&J might not yet have a role in ring-fencing lingering pockets of infection in the current epidemic, and perhaps finally stamping it out.

“I’m pretty optimistic there’s still a role for vaccination in ending this outbreak,” said Hill. “And I’m certainly optimistic that we’ll learn for the next outbreak which of these vaccine approaches is the most likely to work, and be ready to tackle it early on.”



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