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PostPosted: Thu Aug 28, 2014 12:38 pm 
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U.S. officials announce Ebola vaccine trial launch
Liz Szabo, USA TODAY 11:32 a.m. EDT August 28, 2014
The USA plans to begin testing an experimental Ebola vaccine next month, but even in the best case, it won't become available until next year.

U.S. health officials announced that the first human trial of an experimental Ebola vaccine will start next week, and that trials of other vaccines will follow close on its heels.

The vaccine trial will involve 20 healthy volunteers at the campus of the National Institutes of Health in Bethesda, Md., with results expected by the end of the year, said Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Disease.

Although NIH has been developing the vaccine for more than a decade, the public health emergency in West Africa has pushed both the NIH and the Food and Drug Administration to accelerate its development, said NIH director Francis Collins, who said the agencies have taken "extraordinary measures" to launch the study as quickly as possible.

"This is a public health emergency that demands an all-hands-on-deck response," Fauci said.


USATODAY
Ebola outbreak could strike 20,000, WHO says
Fauci called the Ebola epidemic, which has killed half of the 3,000 people infected, an "uncontrolled outbreak" that needs to be contained using traditional methods, such as diagnosing cases, isolating those individuals to prevent them from infecting others, tracing their contacts and testing those people for the disease, as well.

Fauci has previously said that even an experimental vaccine would not be available until the middle of next year. The World Health Organization announced Thursday that it could take six to nine months to contain the current outbreak in Guinea, Sierra Leone, Liberia and Nigeria, and that the outbreak could grow to 20,000 cases.

In a significant announcement, Fauci said that drug giant GlaxoSmithKline (GSK) will co-develop the vaccine. That will make it much easier to "scale up" production of large quantities of the vaccine, if it proves effective, Fauci said. He noted that it has been difficult to produce enough doses of an experimental medication, called ZMapp, which is being developed by a small San Diego biotech company. That company has said that it has given away all of its doses and has none left.

Fauci stressed that the phase 1 study — the earliest of all human tests — is aimed at answering two very basic questions about the vaccine. Is the vaccine safe? Does it provoke the immune system to respond to Ebola? Scientists will be able to gauge the vaccine's prospects for preventing infection by measuring whether a volunteer's immune system mounts a strong response to the Ebola genes in the vaccine.

The vaccine will use a monkey cold virus as a "vector" to deliver Ebola genes to the body. Cold viruses are notoriously good at infecting the body, so they make good delivery vehicles. The viruses act only like delivery trucks, and cannot cause harm. The Ebola genes carried in those viruses can't cause someone to become sick with Ebola, Fauci said. But the genes would direct volunteers' bodies to create one Ebola protein. If the body recognizes that protein as foreign and dangerous, the immune system should create antibodies against it. Those antibodies would protect against a real infection, if the person were to be exposed to Ebola.

The vaccine is designed to protect against two strains of Ebola virus, known as the Zaire and Sudan species. The current outbreak in West Africa is caused by the Zaire strain.

Based on early results, scientists will be able to assess whether to go ahead with larger studies. The vaccine already has performed well in tests in animals, protecting them against Ebola infections.

Volunteers will be evaluated by NIH staff nine times over 48 weeks, Fauci says. To ensure safety of the volunteers — all healthy adults — scientists will give the vaccine to just three people at a time, pausing the trial to check for safety before vaccinating additional volunteers. Safety is "paramount" when testing an experimental drug against healthy people who are not sick or in danger.

Another U.S.-based vaccine study, also using 20 volunteers, will test a vaccine that protects against just the Zaire strain of the virus. That trial also will be conducted at NIH and is set to begin in October, Fauci said.

That vaccine also will be tested in the United Kingdom and the African countries of Mali and Gambia, Fauci said.

NIH scientists also are working with the Department of Defense on an early-stage trial of a third Ebola vaccine, developed by the Public Health Agency of Canada and licensed to NewLink Genetics. That trial will begin this fall at Walter Reed National Military Medical Center.

In addition, the Centers for Disease Control and Prevention has begun talks with the Nigeria's ministry of health to conduct vaccine tests there, Fauci said. The CDC has not yet announced which vaccine it will test in Nigeria.

"We will share data from our studies as quickly as they become available," Fauci said.

The USA has been working on an Ebola vaccine partly to protect against a bioterrorist attack.

The experimental vaccine set to be tested next month was designed by scientist Nancy Sullivan, chief of the biodefense research section in the National Institute of Allergy and Infectious Disease's Vaccine Research Center. She worked with researchers at the U.S. Army Medical Research Institute of Infectious Diseases, and Okairos, a Swiss-Italian biotechnology company bought by GSK last year.

http://www.usatoday.com/story/news/nati ... /14716833/

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PostPosted: Sun Aug 31, 2014 7:38 pm 
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Audio on Anthony Fauci

http://sciencefriday.com/segment/08/29/ ... ebola.html

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PostPosted: Wed Sep 03, 2014 8:16 pm 
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Two Women Receive Experimental Ebola Vaccine in Fast-Tracked Trial
iStock/Thinkstock(BETHESDA, Maryland) — The first two doses of an experimental Ebola vaccine have been injected into human subjects in the National Institutes of Health’s fast-tracked clinical trial.
A 39-year-old woman was the first person to receive the vaccine, which had previously only been tested in monkeys. She received the injection Tuesday at the NIH Clinical Center in Bethesda, Maryland. A 27-year-old woman was given the shot Wednesday, the agency said.
The trial will test the safety of the vaccine, which was developed by GlaxoSmithKline and the NIH’s National Institute of Allergy and Infectious Diseases. It was expedited because of the burgeoning Ebola outbreak in West Africa, where more than 1,900 people have died from the infection, according to the World Health Organization.
The vaccine, which is designed to prevent Ebola, is different from the experimental drug ZMapp, which is designed to treat the infection.
“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the NIH, said in an earlier statement.
Although Fauci said the vaccine has “performed extremely well” in primate studies, this is the first time it has been tested in humans.
The phase 1 clinical trial will involve 20 men and women between the ages of 18 and 50, according to the NIH. Researchers will use the study to determine whether the vaccine is safe and see whether it prompts an immune response necessary to protect against Ebola.
No human subjects will be infected with Ebola.
A $4.7 million grant will also go toward additional Ebola vaccine trials in September at the University of Oxford in England, as well as centers in Gambia and Mali, according to GlaxoSmithKline. In all, 140 patients will be tested.
Though Ebola was discovered nearly 40 years ago, it was so rare that drug manufacturers weren’t interested in investing in finding a vaccine for it, said Dr. William Schaffner, chair of preventive medicine at Vanderbilt University in Nashville, Tennessee. Its rarity also made it impossible for scientists to conduct field studies.
“There’s always the layperson’s query of ‘Why don’t they rush this?’ ‘Why don’t these guys work a little later at night?’” Schaffner told ABC News in July. “It’s a little more complicated than that.”
GlaxoSmithKline became involved in the Ebola vaccine because it bought Swiss vaccine company Okairos AG in 2013. Okairos, originally a Merck spinoff, had been working on the vaccine with the NIH since 2011, a GlaxoSmithKline spokeswoman told ABC News.
Although Fauci said in July that it would take until late 2015 for a vaccine — if successful — to be administered to a limited number of health workers, GlaxoSmithKline said in a statement that the grant will also enable it to manufacture 10,000 doses of the vaccine while the trials are ongoing. If the vaccine trials are successful, it will be able to make stocks available immediately to the World Health Organization.
The NIH said it should have initial data from the trial in late 2014.
The trial for a different vaccine is set to begin at the Walter Reed Army Institute of Research in Silver Spring, Maryland. This vaccine was a collaboration between the federal Department of Defense and Iowa pharmaceutical company NewLink Genetics Corp.

http://www.wlec.com/health/two-women-re ... d-trial-2/

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PostPosted: Thu Sep 04, 2014 5:05 am 
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Johnson & Johnson to Quicken Development of Ebola Virus Vaccine
Company to Start Human Trials in 2015, Nearly a Year Earlier Than Planned, After Africa Outbreak

By ERIN MCCARTHY CONNECT
Sept. 4, 2014 12:01 a.m. ET
Johnson & Johnson JNJ +0.39% said Thursday it is accelerating the development of a vaccine regimen against Ebola, in an effort to help curb the virus that has overwhelmed West Africa.

The regimen consists of two vaccine components from Johnson & Johnson's Crucell NV and Denmark-based biotech company Bavarian Nordic, BAVA.KO +3.23% both of which are developing vaccines against filoviruses, including Ebola. The combination vaccine from the two companies aims to protect against the Zaire strain, which is responsible for the current outbreak across West Africa.

Johnson & Johnson said the vaccine program is being accelerated to allow for clinical trials in humans in early 2015, after promising results in preclinical studies. The company previously had planned to conduct human trials nearly a year later in 2016. The company said the collaboration between Crucell and Bavarian Nordic would enable faster production of the doses necessary to start larger clinical trials.

However, Johnson & Johnson said it was too early in the research process to speculate when the vaccine might be available to the public.

"The decision to accelerate the program is based on the fact that it is such a catastrophic situation in West Africa," said Dr. Paul Stoffels, Johnson & Johnson's chief scientific officer and world-wide chair, in an interview.

The announcement comes as the Ebola virus continues to rage across West Africa, with the death toll topping 1,500 people, according to the World Health Organization. The latest outbreak—the deadliest yet since the virus first emerged in 1976—has resulted in more than 3,000 cases across Guinea, Liberia, Nigeria and Sierra Leone. A separate outbreak emerged in the Democratic Republic of Congo last week.

Two Americans and a small number of other people infected with Ebola earlier this year were treated with an experimental drug that is no longer available. Doctors haven't yet determined whether the drug was helpful to the two Americans.

The vaccine program from Johnson & Johnson and Bavarian Nordic features a prime-boost regimen, which consists of two separate doses to first prime and then later boost the immune response. The vaccine components are based on Crucell's AdVac technology and Bavarian Nordic's MVA-BN technology, which have been used in the evaluation of vaccines.

Preclinical studies of the two companies' vaccine candidates are continuing. However, early data suggest the combination of the two vaccine candidates could lead to a high level of protection against the virus in humans, the company added.

Johnson & Johnson also is starting to work on producing the regimen on a larger scale for clinical testing and is exploring how to increase production for large-scale distribution for human use, Dr. Stoffels said.

Write to Erin McCarthy at erin.mccarthy@wsj.com

http://online.wsj.com/articles/johnson- ... 1409803263

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PostPosted: Thu Sep 04, 2014 5:29 am 
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Ebola outbreak: Johnson & Johnson get OK to fast-track vaccine trials
Human tests not expected for at least a year
Thomson Reuters Posted: Sep 04, 2014 12:40 AM ET Last Updated: Sep 04, 2014 12:40 AM ET
Image
Crucell's headquarters in Leiden, Netherlands are shown in this file photo. The vaccine Johnson & Johnson will be testing was developed at Crucell. (Jan Daniels/The Associated Press)

Scientists will fast-track tests on another Ebola vaccine, this time from Johnson & Johnson, in another sign that the world's worst outbreak of the virus is mobilizing research into the deadly disease.

J&J said on Thursday that clinical trials of its new vaccine, which includes technology from Danish biotech firm Bavarian Nordic, would commence in early 2015.

The move follows a decision to begin initial human testing of a GlaxoSmithKline vaccine this month and plans to test one developed by scientists at the National Microbiology Laboratory in Winnipeg, which has been licensed to NewLink Genetics, in the autumn.

'The crisis is so important here, and still expanding, that more than one approach is warranted, in case the epidemic doesn't come under control in the coming months'
- Paul Stoffels, chief scientific officer at Johnson & Johnson
Human tests on the J&J vaccine were previously not expected to start until late 2015 or early 2016.

J&J's long-term goal is to develop a vaccine that can protect against both the Zaire and Sudan strains of Ebola, as well as a related condition called Marburg disease. But the program has been simplified in light of the current outbreak.

"Because of the emergency we decided to focus on the Ebola Zaire strain, which is the one in the West Africa outbreak, and that's why we can accelerate the program significantly," Chief Scientific Officer Paul Stoffels told Reuters.

As with the GSK and NewLink programmes, J&J is working on the clinical trials with the U.S. National Institute of Allergy and Infectious Diseases, part of National Institutes of Health.

"The crisis is so important here, and still expanding, that more than one approach is warranted, in case the epidemic doesn't come under control in the coming months," Stoffels said.

All of the initial Phase I trials will enrol healthy volunteers with the goal of determining whether the experimental vaccines are safe and whether they provoke a protective immune response.

Stoffels said it had not yet been decided where trials on the J&J vaccine would be conducted or how many subjects would be involved.

The race to develop new drugs and vaccines has been spurred by a World Health Organization ruling that it is ethical to use experimental products in the current epidemic, given the high death toll.

Governments and aid organizations have scrambled to contain the disease, which according to the United Nations agency has killed more than 1,900 in West Africa since March.

J&J said its vaccine, which was developed by its Crucell unit in the Netherlands, provided complete protection against the Zaire strain of Ebola when tested on macaque monkeys.

J & J vaccine involves pair of injections

Like a number of other experimental vaccines against various diseases that are now in development, it uses a common cold virus, called an adenovirus, to carry its payload.

Immunization with the J&J vaccine consists of two injections — one to prime the immune system and a second to boost the response. They were given two months apart in the monkey tests. By contrast, researchers are testing just a single shot of GSK's vaccine.

How safe and effective J&J's product will be in humans remains to be seen, but more than 1,000 people have already received similar experimental vaccines from Crucell in clinical trials for other diseases with no apparent ill effects, offering some reassurance.

Bavarian Nordic, meanwhile, has used a similar approach in producing a smallpox vaccine that has been stockpiled around the world and tested on more than 7,300 people.

J&J is also stepping up research into potential drugs for Ebola by undertaking an intensive review of known biological pathways used by the virus to see if previously tested medicines might help.

http://www.cbc.ca/news/health/ebola-out ... 49?cmp=rss

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PostPosted: Thu Sep 04, 2014 5:34 am 
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J&J Ebola vaccine to start clinical trials in early 2015
BY BEN HIRSCHLER
Sept 4 Thu Sep 4, 2014 9:48am IST

(Reuters) - Scientists will fast-track tests on another Ebola vaccine, this time from Johnson & Johnson JNJ.N, in another sign that the world's worst outbreak of the virus is mobilizing research into the deadly disease.

J&J said on Thursday that clinical trials of its new vaccine, which includes technology from Danish biotech firm Bavarian Nordic BAVA.CO, would commence in early 2015.

The move follows a decision to begin initial human testing of a GlaxoSmithKline GSK.L vaccine this month and plans to test one developed by Canadian government scientists, which has been licensed to NewLink Genetics NLNK.O, in the autumn.

Human tests on the J&J vaccine were previously not expected to start until late 2015 or early 2016.

J&J's long-term goal is to develop a vaccine that can protect against both the Zaire and Sudan strains of Ebola, as well as a related condition called Marburg disease. But the program has been simplified in light of the current outbreak.

“Because of the emergency we decided to focus on the Ebola Zaire strain, which is the one in the West Africa outbreak, and that’s why we can accelerate the program significantly,” Chief Scientific Officer Paul Stoffels told Reuters.

As with the GSK and NewLink programs, J&J is working on the clinical trials with the U.S. National Institute of Allergy and Infectious Diseases, part of National Institutes of Health.

“The crisis is so important here, and still expanding, that more than one approach is warranted, in case the epidemic doesn’t come under control in the coming months,” Stoffels said.

All of the initial Phase I trials will enroll healthy volunteers with the goal of determining whether the experimental vaccines are safe and whether they provoke a protective immune response.

Stoffels said it had not yet been decided where trials on the J&J vaccine would be conducted or how many subjects would be involved.

The race to develop new drugs and vaccines has been spurred by a World Health Organization ruling that it is ethical to use experimental products in the current epidemic, given the high death toll.

Governments and aid organizations have scrambled to contain the disease, which according to the United Nations agency has killed more than 1,900 in West Africa since March.

J&J said its vaccine, which was developed by its Crucell unit in the Netherlands, provided complete protection against the Zaire strain of Ebola when tested on macaque monkeys.

Like a number of other experimental vaccines against various diseases that are now in development, it uses a common cold virus, called an adenovirus, to carry its payload. Immunization with the J&J vaccine consists of two injections

one to prime the immune system and a second to boost the response. They were given two months apart in the monkey tests. By contrast, researchers are testing just a single shot of GSK's vaccine.

How safe and effective J&J's product will be in humans remains to be seen, but more than 1,000 people have already received similar experimental vaccines from Crucell in clinical trials for other diseases with no apparent ill effects, offering some reassurance.

Bavarian Nordic, meanwhile, has used a similar approach in producing a smallpox vaccine that has been stockpiled around the world and tested on more than 7,300 people.

J&J is also stepping up research into potential drugs for Ebola by undertaking an intensive review of known biological pathways used by the virus to see if previously tested medicines might help.
http://in.reuters.com/article/2014/09/0 ... rit=309303

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PostPosted: Mon Sep 22, 2014 12:20 pm 
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UK clinical trial is recruiting

https://clinicaltrials.gov/ct2/show/NCT ... ola&rank=2

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