Rhiza Labs FluTracker Forum

The place to discuss the flu
It is currently Fri Oct 20, 2017 7:14 pm

All times are UTC - 5 hours [ DST ]




Post new topic Reply to topic  [ 17 posts ]  Go to page 1, 2  Next
Author Message
PostPosted: Thu Aug 28, 2014 8:09 am 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
Media reports describe the start of Ebola vaccine trials (Adenovirus based) scheduled to start next week in the United States (Bethesda, Maryland), followed by trials in the UK and Africa.

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 8:10 am 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
First Human Trials of Ebola Vaccine Start Next Week
BY MAGGIE FOX

The first human trials of a vaccine against the deadly Ebola virus will start next week in the U.S., officials announced Thursday, just as the World Health Organization predicted as many as 20,000 people could be infected in West Africa before the epidemic is brought under control.

The National Institutes of Health will sponsor the first trial of the vaccine, one of several being developed against Ebola. It’s fast-tracked the testing because of the outbreak of Ebola that is ravaging three West African countries.

"The early stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults," the NIH said in a statement. "Testing will take place at the NIH Clinical Center in Bethesda, Maryland."

Ebola has killed more than 1,500 people out of more than 3,000 infected in Liberia, West Africa and Guinea in the ongoing outbreak, by far the worst outbreak of Ebola ever seen. And the WHO says those numbers almost certainly understate the true numbers of those infected and killed. WHO predicted on Thursday that as many as 20,000 could become infected.

"Testing will take place at the NIH Clinical Center in Bethesda, Maryland."

"In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali," NIH said.

"Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country."

The National Institute of Allergy and Infectious Diseases, part of the NIH, has been working on an Ebola vaccine for years. The idea was to develop it to defend people in case Ebola or a related virus, Marburg, was ever used in a biological attack. Previous outbreaks of the virus were always too small and too easily controlled to justify developing a vaccine quickly.

NIAID was working with a small Swiss-Italian biotech company called Okairos to develop the vaccine. It’s been shown to protect monkeys against Ebola.

Glaxo bought the company last year.

The next step is to test the vaccine in people, both to see if it’s safe and to see if it stimulates the immune system in a way that would be predicted to protect people from infection.

The vaccine is made using a virus called an adenovirus that infects chimpanzees but not people. The virus is genetically engineered with a single piece of Ebola virus, a protein that the immune system can recognize, but which doesn’t make people sick.

Several other companies are working to develop Ebola vaccines, including Crucell, a small biotech called Profectus Biosciences, Iowa-based NewLink Genetics and Immunovaccine Inc, based in Nova Scotia, Canada.

Two American medical missionaries, Dr. Kent Brantly and Nancy Writebol, were treated with an experimental therapy made by California-based Mapp Biopharmaceutical. Three Liberian doctors also received the drug. One died and the other two have recovered.

WHO published what it called a road map on Thursday for fighting the outbreak.

"Clearly, a massively scaled and coordinated international response is needed to support affected and at-risk countries in intensifying response activities and strengthening national capacities," it says.

"Clearly, a massively scaled and coordinated international response is needed."

"Response activities must be adapted in areas of very intense transmission and particular attention must be given to stopping transmission in capital cities and major ports, thereby facilitating the larger response and relief effort."

This outbreak is different from other outbreaks across Africa over the past 40 years, it says.

"This Roadmap assumes that in many areas of intense transmission the actual number of cases may be 2-4 fold higher than that currently reported," it says.

None of the provisions call for vaccination -- it's far to soon for that. Instead, the plan calls for better tracking down and diagnosis of cases, a fast-track training program to get more health workers on the job, safer burials and better control of travelers.

“Today we know the best way to prevent the spread of Ebola infection is through public health measures, including good infection control practices, isolation, contact tracing, quarantine, and provision of personal protective equipment,” NIAID director Dr. Tony Fauci said in a statement. “However, a vaccine will ultimately be an important tool in the prevention effort. The launch of Phase 1 Ebola vaccine studies is the first step in a long process.”

First published August 27th 2014, 10:28 pm
http://www.nbcnews.com/storyline/ebola- ... ek-n190716

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 9:20 am 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
Glaxo’s Ebola Vaccine to Be Tested for Safety in Humans
By Anna Edney Aug 28, 2014 7:41 AM ET

U.S. scientists will begin enrolling patients as soon as next week in clinical safety trials of GlaxoSmithKline Plc (GSK)’s experimental Ebola vaccine as the death toll from the disease rises in West Africa.

The National Institutes of Health’s Vaccine Research Center received approval from the Food and Drug Administration to start the Phase 1 trial, Michael Kurilla, director of the Office of Biodefense, Research Resources and Translational Research, said yesterday in a telephone interview. A Phase 1 trial is the first test of a drug or vaccine in humans to assess safety and whether it works similarly to how it does in animals.

The current outbreak has killed 1,552 people in four countries and may soon claim more deaths than all previous Ebola outbreaks combined. The NIH and London-based Glaxo are jointly developing the experimental vaccine, which doesn’t contain any infectious Ebola virus. Health authorities are discussing whether to give the vaccine to at-risk people in West Africa, Kurilla said.


“Exactly how all that will be done is yet to be seen and is a topic of a number” of conference calls every day, he said.

Protecting Against Ebola

Researchers may need to study the vaccine in humans for about a month to assess its effect, Kurilla said. NIH Director Francis Collins is scheduled to speak about the agency’s work on Ebola vaccines.

Tests of the vaccine will be conducted on healthy people in the U.S., the U.K., Gambia and Mali, Glaxo said in a statement today. The Phase 1 U.K. tests, led by researchers at the University of Oxford, could start in mid-September on 60 volunteers if regulators approve, Glaxo said.

Provided there are no adverse affects, trials will extend to 40 volunteers in Mali and the same number in Gambia. The first phase could be completed by the end of the year, Glaxo said. A 2.8 million-pound ($4.6 million) grant from the U.K. government and the Wellcome Trust will fund testing as well as Glaxo’s manufacturing of as much as about 10,000 doses of the vaccine. This way, if the trials are successful, the medicine will immediately be available for immunization programs.

NewLink Genetics Corp. (NLNK), based in Ames, Iowa, also is working on an Ebola vaccine and said yesterday it has contracted with a third party to manufacture the product and augment its current supply, which the company said is adequate to begin pre-clinical trials.

Ebola Meeting

Kurilla will serve as a subject-matter expert next week when the World Health Organization is scheduled to meet and discuss Ebola drugs and vaccines under development.

Treatments include those from Mapp Biopharmaceutical Inc., Fujifilm Holdings Corp., BioCryst Pharmaceuticals Inc. and Tekmira Pharmaceuticals Corp. (TKMR), Kurilla said.

Mapp’s experimental medicine ZMapp is “front and center in terms of what people consider a good intervention,” Kurilla said.

Some Ebola patients, including American health workers Kent Brantly and Nancy Writebol, have been treated with ZMapp though the closely held San Diego-based company has said their supply is exhausted.

Japanese drugmaker Fujifilm (4901) said it has sufficient stockpiles of its experimental flu drug favipiravir that may work against Ebola. Japan is prepared to provide unregistered Ebola drugs on request, Chief Cabinet Secretary Yoshihide Suga said in a briefing on Aug. 25.

Seeking Approval

Fujifilm’s U.S. partner MediVector Inc. in Boston is in talks with the FDA to submit an application to use the drug in humans for Ebola, Amy Derrick-Frost, a spokeswoman for Department of Defense, said on Aug. 9. The Defense Department has prioritized the completion of a study that tests the drug in Ebola-infected monkeys.

BioCryst’s BCX4430 has been tested in non-human primates against a similar virus, Marburg, which Kurilla expects “would predict a positive impact on Ebola.” NIH contracted with BioCryst (BCRX) to develop the drug through Phase 1 trials as a treatment for hemorrhagic fever viruses. The contract may total as much as $26 million, according to a statement from the company.

A study using the drug on non-human primates is gearing up now, Kurilla said. “It depends on when they can get the monkey,” he said.

Tekmira’s Drug

Tekmira’s experimental Ebola drug is under a partial clinical hold though the FDA has said the Canadian drugmaker could possibly give the medicine to infected patients. Tests of the drug, known as TKM-Ebola, were delayed due to safety concerns.

WHO advisers determined earlier this month experimental treatments against Ebola are ethical to use to help infected patients. More than 2,600 cases have been reported Ebola in Liberia, Guinea, Sierra Leone and Nigeria since December, the WHO has said.

Kurilla expects WHO to also discuss a class of drugs known as selective estrogen receptor modulators as a possible treatment. Scientists published research last year in the journal Science Translational Medicine showing such drugs, which are hormone therapies used to treat breast cancer and infertility, may work against Ebola.

More than $430 million will be needed to bring the worst Ebola outbreak on record under control, according to a draft document laying out the WHO’s strategy. The African Development Bank will prepare an additional $150 million in funding above the $60 million it already pledged to help the countries fight the virus.

The U.S. Agency for International Development said yesterday it will provide an additional $5 million to help combat the outbreak, bringing its total to $19.6 million.

“The additional funding will be used to provide health equipment and emergency supplies, train and support health care workers on infection control and case management, support public outreach campaigns, and help build the capacity of local health care and emergency response systems,” according to a statement from the agency.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Kristen Hallam

http://www.bloomberg.com/news/2014-08-2 ... umans.html

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 9:28 am 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
NIH HHS News Release Logo National Institute of Allergy and
Infectious Diseases (NIAID)
http://www.niaid.nih.gov
FOR IMMEDIATE RELEASE
Thursday, Aug. 28, 2014
Media Contact:
​Kathy Stover
(301) 402-1663
niaidnews@niaid.nih.gov Skip Content Marketing
Share this:submit to facebook Tweet it submit to reddit submit to StumbleUpon submit to Google +
NIH to Launch Human Safety Study of Ebola Vaccine Candidate
​Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland.

The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.

In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.

Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country.

The pace of human safety testing for experimental Ebola vaccines has been expedited in response to the ongoing Ebola virus outbreak in West Africa. According to the World Health Organization (WHO), more than 1,400 suspected and confirmed deaths from Ebola infection have been reported in Guinea, Liberia, Nigeria, and Sierra Leone since the outbreak was first reported in March 2014.

“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,” said NIAID Director Anthony S. Fauci, M.D. “The NIH is playing a key role in accelerating the development and testing of investigational Ebola vaccines.”

“Today we know the best way to prevent the spread of Ebola infection is through public health measures, including good infection control practices, isolation, contact tracing, quarantine, and provision of personal protective equipment,” added Dr. Fauci. “However, a vaccine will ultimately be an important tool in the prevention effort. The launch of Phase 1 Ebola vaccine studies is the first step in a long process.”

“Tried and true public health interventions, strong supportive medical care and the rapid testing of Ebola vaccines and antiviral treatments can help to reduce suffering now and in the future,” said CDC Director Thomas R. Frieden, M.D., M.P.H.

The investigational vaccine now entering Phase 1 trials was designed by Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC). She worked in collaboration with researchers at the VRC, the U.S. Army Medical Research Institute of Infectious Diseases, and Okairos, a Swiss-Italian biotechnology company acquired by GSK in 2013.

Phase 1 clinical trials are the first step in what is typically a multi-stage clinical trials process. During Phase 1 studies, researchers test an investigational vaccine in a small group of people to evaluate its safety and the immune response it provokes. Phase 2 clinical trials of investigational vaccines are designed to further assess safety and immune response in larger numbers of volunteers. Under certain circumstances, the vaccine’s ability to prevent infection or disease (called efficacy) can be determined in a Phase 2 trial. Phase 3 clinical trials are directed predominantly at determining efficacy.

The NIAID/GSK Ebola vaccine candidate is based on a type of chimpanzee cold virus, called chimp adenovirus type 3 (ChAd3). The adenovirus is used as a carrier, or vector, to deliver segments of genetic material derived from two Ebola virus species: Zaire Ebola and Sudan Ebola. Hence, this vaccine is referred to as a bivalent vaccine. The Zaire species of the virus is responsible for the current Ebola outbreak in West Africa.

The vaccine candidate delivers one part of Ebola’s genetic material to human cells, but the adenovirus vector does not replicate. Rather, the Ebola gene that it carries allows the cells of the vaccine recipient to express a single Ebola protein, and that protein prompts an immune response in the individual. It is important to know that the Ebola genetic material contained in the investigational vaccine cannot cause a vaccinated individual to become infected with Ebola.

“The experimental NIAID/GSK vaccine performed extremely well in protecting nonhuman primates from Ebola infection,” Dr. Fauci noted.

The candidate vaccine builds upon three earlier NIAID-developed investigational Ebola vaccines that began Phase 1 clinical trial testing in 2003.

“The knowledge gained from each of those trials has contributed to the development of the candidate vaccine we are now studying, as well as our improved understanding of human immune responses to investigational Ebola vaccines,” said John R. Mascola, M.D., director of NIAID’s Vaccine Research Center.

The Phase 1 clinical trial, called VRC 207, will be led by principal investigator Julie E. Ledgerwood, D.O., chief of the VRC’s clinical trials program, and will be conducted among 20 healthy adults ages 18 to 50 years. Participants will be divided into two groups of 10 participants each. One group will receive an intramuscular injection of the NIAID/GSK experimental vaccine. The second group will receive a single injection of the same vaccine but at a higher dose.

A number of safety features are built into the study’s design, including daily and weekly reviews of patient data by clinical staff and the study protocol team. Additionally, the trial features a staged enrollment plan that requires interim safety reviews after three participants have been vaccinated and have undergone three days of follow up before enrolling additional study participants into the group. Participants in both groups will be seen and evaluated by clinical staff nine times over a 48-week period.

Additional Phase 1 Tests of the NIAID/GSK Vaccine

As part of the VRC 207 trial, NIAID will also test a version of the NIAID/GSK vaccine that contains genetic material from only the Zaire Ebola species. Hence, this vaccine is referred to as a monovalent vaccine. This portion of the Phase 1 safety study, which will also involve 20 healthy adults, is expected to begin in October at the NIH Clinical Center and potentially another U.S. location. Dr. Ledgerwood will also lead that effort. The VRC 207 clinical trial is being conducted based on expedited review and approval by the U.S. Food and Drug Administration.

In parallel, NIH has partnered with an international consortium that includes the British-based Wellcome Trust, as well as Britain’s Medical Research Council and Department for International Development to test the same NIAID/GSK monovalent vaccine candidate. The vaccine candidate will be tested among 60 healthy volunteers at the University of Oxford in England and among 40 healthy volunteers in Mali by the University of Maryland School of Medicine Center for Vaccine Development and its Center for Vaccine Development in Mali (a joint enterprise of the University of Maryland School of Medicine and the Ministry of Health of Mali). Additionally, the vaccine candidate is expected to be tested among 40 healthy volunteers in Gambia after approval from the relevant authorities.

The Oxford trial is expected to launch in mid-September pending ethical and regulatory approval.

“Today’s announcement shows how private and public partners can pull together to quickly respond to this critical public health emergency. Developing a new vaccine is complex with no guarantees of success, and we are still in the early days for our Ebola vaccine candidate. But we are encouraged by progress so far and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to this or future Ebola outbreaks,” said Dr. Moncef Slaoui, chairman of Global R&D and Vaccines at GSK.

Initial safety and immunogenicity data from the Phase 1 trials of the NIAID/GSK investigational Ebola vaccine are expected in late 2014.

Vesicular Stomatitis Virus (VSV) Ebola Vaccine Testing

The NIH will also collaborate with the U.S. Department of Defense in support of efforts by NewLink Genetics Corp., a biopharmaceutical company in Ames, Iowa, to conduct Phase 1 safety studies of the investigational recombinant vesicular stomatitis virus Ebola vaccine (called VSV-EBOV) developed by and licensed from the Public Health Agency of Canada. Those clinical trials are expected to begin in the fall at the Clinical Trials Center of Walter Reed Army Institute of Research in Silver Spring, Maryland.

For more information about these early-stage Ebola vaccine clinical trials, see Questions and Answers: Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health ®
http://www.niaid.nih.gov/news/newsrelea ... idate.aspx

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 9:35 am 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
GSK & NIAID Ebola Vaccine To Enter UK Human Safety Trials; Broad International Collaboration

The Wellcome Trust, the Medical Research Council (MRC), and the UK Department for International Development (DFID) have announced this morning that an Ebola vaccine developed in the U.S. will enter human safety trials in the UK as early as September. The consortium is devoting £2.8 million to the effort.

The National Institute of Allergy and Infectious Diseases (NIAID), an arm of the U.S. National Institutes of Health, will be holding a press conference within the hour to discuss specifics on the vaccine itself. This post will be updated as more information becomes available.

What we know now is the a team at the University of Oxford’s Jenner Institute, led by Professor Adrian Hill, will begin dosing UK volunteers concomitant to similar phase 1 trials in the States.

The vaccine was designed by Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC). She worked with other collaborators in the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) and scientists at the Swiss-Italian biotechnology company, Okairos, acquired by GlaxoSmithKline in May, 2013.

GSK is gearing up to produce an additional 10,000 doses of vaccine while the phase 1 trials proceed. If the trials are successful, GSK will make the vaccine available to the World Health Organization for an emergency vaccination program in high-risk African communities.

While the vaccine has proven to protect non-human primates from Ebola infection and produced high levels of immunogenic responses, the phase 1 trials are being conducted to ensure that any untoward reactions in humans are detected and the production of protective antibodies proceeds as observed in non-human primates.


Should the vaccine proves safe in U.S. and U.K. trials, it will be tested in human volunteers at the MRC unit in The Gambia and in Mali, through a joint initiative with the University of Maryland and the Mali Ministry of Health. Myron M. Levine of the Center for Vaccine Development at the University of Maryland School of Medicine, and Professor Samba Sow of the Center for Vaccine Development in Mali would begin trials in the capital city of Bamako.

The vaccine is directly at the Zaire Ebola virus, currently circulating in West African nations of Sierra Leone, Guinea, and Liberia. NIAID will also be testing a second vaccine that is intended to protect against both the Zaire and Sudan strains of Ebola.

That experimental Ebola vaccine was developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp.

The WHO announced overnight that the pandemic continues to expand, with 40% of the total cases thus far occurring in the last 21 days. The expectation is that 20,000 will be infected as it take 6 to 9 months to quell the outbreak.

The WHO has now confirmed a second, unrelated outbreak in the Democratic Republic of Congo (DRC), the former country of Zaire, where the Ebola virus first emerged in contemporary times.

This is a direct excerpt of the WHO’s report this morning on this new development:

The index case was a pregnant woman from Ikanamongo Village who butchered a bush animal that had been killed and given to her by her husband. She became ill with symptoms of EVD [Ebola Virus Disease] and reported to a private clinic in Isaka Village. On 11 August 2014, she died of a then-unidentified haemorrhagic fever. Local customs and rituals associated with death meant that several health-care workers were exposed and presented with similar symptoms in the following week.

Between 28 July and 18 August 2014, a total of 24 suspected cases of haemorrhagic fever, including 13 deaths, have been identified.

The term “index case” refers to the first person detected with the virus in an outbreak. Authorities have also taken to renaming Ebola hemorrhagic fever to the more encompassing Ebola Virus Disease, or EVD, as only about 20% of patients have been displaying hemorrhagic symptoms.

For more health and pharmaceutical news and commentary, follow me on Twitter @DavidKroll, here at Forbes.com, or subscribe to my public updates by clicking “Follow” on my Facebook.

http://www.forbes.com/sites/davidkroll/ ... aboration/

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 9:40 am 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
QUESTIONS AND ANSWERS
Phase 1 Clinical Trials of NIAID/GSK Investigational Ebola Vaccine
August 28, 2014

See News Release

Describe the Ebola vaccine candidate that NIAID will test.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will be testing in early-stage human clinical trials an Ebola vaccine candidate developed by Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC), working in collaboration with a team of VRC researchers and scientists at the Army Medical Research Institute of Infectious Diseases and Okairos, a Swiss-Italian biotechnology company acquired by GlaxoSmithKline in 2013. The candidate, called NIAID/GSK Ebola vaccine, is designed to prevent Ebola virus disease.

The investigational vaccine is based on a recombinant type of chimpanzee “cold” virus, called chimp adenovirus type 3 (ChAd3). The adenovirus is used as a carrier, or vector, to deliver segments of genetic material derived from two Ebola virus species: Zaire Ebola and Sudan Ebola. The Zaire species of the virus has caused the current Ebola outbreak in West Africa. The vaccine delivers one part of the Ebola genetic material to human cells but the adenovirus vector does not replicate. Rather, the Ebola gene that it carries allows the cells of the vaccine recipient to express a single Ebola protein, and that protein prompts an immune response in the individual.

NIAID will test two versions of the NIAID/GSK vaccine: a bivalent version containing genetic material derived from the Zaire and Sudan Ebola species and a monovalent version derived from genetic material from only the Zaire Ebola species.

Can a study volunteer injected with the investigational NIAID/GSK Ebola vaccine become infected with Ebola?
No. The Ebola genetic material contained in the investigational vaccine cannot cause someone to become infected with Ebola.

What is the design of the clinical trial, who is the sponsor of the study, and where is it being conducted?
The VRC 207 study is a Phase 1 clinical trial designed to test the safety of the NIAID/GSK investigational Ebola vaccine and its ability to generate an immune system response. Both the bivalent and monovalent versions of the vaccine will be tested in connection with this trial. NIAID is sponsoring the VRC 207 study, which will be led by principal investigator Julie E. Ledgerwood, D.O., chief of the VRC’s clinical trials program. The study will begin testing the bivalent (Zaire and Sudan Ebola species) investigational vaccine during the week of September 1, 2014, at the NIH Clinical Center in Bethesda, Maryland. That portion of the trial will involve 20 healthy adults ages 18 to 50 years. Participants in the study will be divided into two groups (10 participants each). One group will receive an intramuscular injection of the NIAID/GSK experimental vaccine (2x1010 particle units (PU), one milliliter (mL) volume). The second group of 10 participants will also receive a single injection of the experimental vaccine but at a higher dose (2x1011 PU/1 mL).

Testing of the monovalent version (Zaire Ebola species) of the NIAID/GSK Ebola vaccine candidate is expected to begin in October. That portion of the Phase 1 safety study, which will also involve 20 healthy adults, will be conducted at the NIH Clinical Center and potentially another U.S. site. Dr. Ledgerwood will lead the monovalent vaccine testing as well.

The VRC 207 trial is being conducted based on expedited review and approval by the U.S. Food and Drug Administration (FDA).

How will the safety of the study participants in the VRC 207 trial be ensured?
The well-being and safety of study participants is always our top priority. To begin, the VRC 207 protocol was independently reviewed by NIAID, the FDA and an institutional review board (IRB). Those reviews were done to ensure that the study would be scientifically, ethically, and clinically appropriate and that it would adhere to accepted standards for protecting human clinical research participants. Volunteers who meet the study’s eligibility criteria must provide oral and written informed consent to participate.

A number of safety features are built into the study’s design, including daily and weekly reviews of patient data by clinical staff and the study protocol team. Additionally, the trial features a staged enrollment plan that requires interim safety reviews after three participants have been vaccinated and have undergone three days of follow up before enrolling additional study participants into the group. Participants in both groups will be seen and evaluated by clinical staff nine times over a 48-week period.

Is this the first Ebola investigational vaccine to be tested by NIAID?
No. NIAID has developed and tested three earlier investigational Ebola vaccine candidates that began Phase 1 clinical trials in 2003. The NIAID/GSK Ebola vaccine candidate that is being tested in the VRC 207 clinical trial is built upon the knowledge gained from those three earlier clinical trials. Additionally, the two components of the NIAID/GSK vaccine—the chimp adenovirus type 3 vector and the genetic material encoding Ebola glycoprotein—have both been shown to be safe in humans in other Phase 1 trials.

Will tests of the NIAID/GSK investigational Ebola vaccine also be taking place internationally?
Yes. In parallel with the VRC 207 trial, the NIH has partnered with a United Kingdom-based international consortium that includes the Wellcome Trust, the U.K.’s Medical Research Council and the Department for International Development to test the same NIAID/GSK monovalent vaccine candidate. Specifically, the vaccine candidate will be tested among 60 healthy volunteers at the University of Oxford in the United Kingdom and among 40 healthy volunteers in Mali. The University of Maryland School of Medicine Center for Vaccine Development and its Center for Vaccine Development in Mali will conduct the Mali study as a joint enterprise between the University of Maryland School of Medicine and the Ministry of Health of Mali. The vaccine candidate is also expected to be tested among 40 healthy volunteers in Gambia after approval from the relevant authorities.

The Oxford trial is expected to launch in mid-September pending ethical and regulatory approval.


Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country.


When do you expect to have data from the Phase 1 safety studies?
The initial safety and immunogenicity data from the Phase 1 NIAID/GSK Ebola vaccine trials are expected by late 2014.

If the safety data is promising, will the NIH make the vaccine available to people working on the frontlines of the Ebola outbreak in West Africa?
There are active discussions underway about when and how to bring experimental interventions into the areas currently affected by Ebola virus disease. NIH believes that it is critical to first obtain Phase 1 safety testing data.

Is NIH testing or supporting research on other Ebola vaccine candidates?
The NIH will also be collaborating with the U.S. Department of Defense in support of efforts by NewLink Genetics Corp., an Ames, Iowa-based biopharmaceutical company, to conduct Phase 1 safety studies of the investigational recombinant vesicular stomatitis virus Ebola vaccine (called VSV-EBOV) developed by and licensed from the Public Health Agency of Canada. Those clinical trials are expected to begin sometime in the fall at the Clinical Trials Center of the Walter Reed Army Institute of Research in Silver Spring, Maryland.

In addition to the investigational vaccines entering Phase 1 clinical trials, NIAID is supporting the development of other Ebola vaccine candidates. Specifically, NIAID support is assisting Crucell, a Netherlands-based biotechnology company, and Bavarian Nordic, based in Denmark. Crucell is developing a multivalent Ebola/Marburg vaccine using a recombinant adenovirus platform. An initial Phase 1 clinical trial of this candidate vaccine is anticipated to begin by late 2015. Bavarian Nordic is developing a Marburg vaccine using a modified vaccinia Ankara platform, and this vaccine is currently in preclinical development.

NIAID also is funding Profectus Biosciences, a Baltimore, Maryland-based biotechnology company, to develop a candidate vaccine targeting Ebola and Marburg infections. That product is currently in preclinical testing and is not expected to enter Phase 1 testing in the near-term.

Investigators from NIAID’s Division of Intramural Research and Thomas Jefferson University in Philadelphia have developed an investigational Ebola vaccine using the established rabies virus vaccine platform​. When tested in mice, the vaccine was strongly immunogenic and provided protection against both Ebola and rabies infection. Three different test versions of the vaccine candidate were found to be safe and to produce potent immune responses against both rabies and Ebola viruses when tested in nonhuman primates. Additionally, the three versions of the vaccine candidate conferred 50 to 100 percent protection from Ebola infection in nonhuman primates. The researchers are currently pursuing an inactivated version of the vaccine for testing in humans.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.

​​​​​
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health ®
http://www.niaid.nih.gov/news/QA/Pages/EbolaVaxQA.aspx

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 12:13 pm 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
GSK to start production of Ebola vaccine as tests on humans begin
Clinical safety trials begin in US next week, after approval from the FDA; volunteer testing in UK and Africa from September

Julia Kollewe
theguardian.com, Thursday 28 August 2014 07.46 EDT

Image
Protective equipment used by health workers in the Ebola isolation ward at a hospital in Sierra Leone. Photograph: Michael Duff/AP
GlaxoSmithKline's experimental Ebola vaccine could be tested on humans in the UK, US, the Gambia and Mali in the next few weeks, in a race to contain the deadly virus that has claimed more than 1,500 lives in west Africa.

The news came as the World Health Organisation (WHO) warned that the Ebola epidemic could eventually exceed 20,000 cases. Bruce Aylward, WHO's assistant director-general for emergency operations, said: "This far outstrips any historic Ebola outbreak in numbers. The largest outbreak in the past was about 400 cases."

Human trials of GSK's experimental vaccine – which Britain's largest pharmaceuticals company is developing with the US National Institutes of Health (NIH) – are to be fast-tracked, with funding from an international consortium. Vaccines normally take 10 years to develop, but GSK said it hopes to finish the first phase of trials by the end of 2014. It will start making up to 10,000 doses of the vaccine at the same time as the initial clinical trials, so that – if they prove successful – stocks could be made available immediately to the WHO to vaccinate people in high-risk communities.

The Ebola outbreak has killed 1,552 people in Sierra Leone, Liberia, Guinea and Nigeria out of 3,069 cases, according to the WHO's latest figures. It has declared the epidemic an international health emergency and published an action plan on Thursday to contain the disease within six to nine months.

If regulatory approvals are granted, the UK research teams could start vaccinating healthy volunteers from mid-September. In the US, the NIH could start phase 1 trials – the first test on humans to assess safety and efficacy – at its clinical centre in Bethesda, Maryland, as soon as next week after receiving the green light from the US health regulator, the Food and Drug Administration. The vaccine has already shown promising results in primates exposed to Ebola, without significant adverse effects.

A £2.8m grant from the Wellcome Trust, the Medical Research Council and the Department for International Development will fund safety tests by a team led by Prof Adrian Hill, director of the Jenner Institute at the University of Oxford. If successful, the trial will be extended to volunteers at the MRC unit in the Gambia, and to Bamako, Mali.

The US Centres for Disease Control and Prevention has begun discussions with ministry of health officials in Nigeria about conducting a phase 1 safety study of the vaccine among healthy adults.

The Oxford study will involve 60 healthy volunteers, while those in the Gambia and Mali will each involve 40. Each set of volunteers will be split into groups of 20 who will receive different doses of the vaccine, which is based on a type of chimpanzee cold virus and does not contain infectious Ebola virus material. Two Ebola genes have been inserted into the vaccine, and express a single Ebola virus protein to generate an immune response.

Hill said: "The tragic events unfolding in Africa demand an urgent response. In recent years, similar investigational vaccines have safely immunised infants and adults against a range of diseases including malaria, HIV and Hepatitis C. We, and all our partners on this project, are optimistic that this candidate vaccine may prove useful against Ebola."

The experimental vaccine is against the Zaire species of Ebola, which is the one circulating in west Africa and for which there is no cure. The vaccine was designed by Nancy J Sullivan, the head of the biodefence research section in NIAID's Vaccine Research Centre (part of NIH), in collaboration with researchers at the Swiss-Italian biotech firm Okairos, acquired by GSK last May for €250m (£150m).

NIAID is also supporting work on other early-stage Ebola vaccines, including one from Johnson & Johnson's Crucell division that is expected to enter early clinical studies around the turn of the year.

NewLink Genetics, based in Iowa, is also working on an Ebola vaccine and has just struck a deal with another firm to manufacture the product and increase its supply, before starting preclinical trials.

Experimental Ebola treatments include ZMapp, made by San Diego-based Mapp Biopharmaceutical. The drug has been given to Will Pooley, the British nurse who contracted the virus in Sierra Leone and has been flown back to London.

http://www.theguardian.com/society/2014 ... ine-humans

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 12:28 pm 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
28 August 2014 Last updated at 08:18 ET
Ebola vaccine to be tested on UK volunteers
By Smitha Mundasad
Health reporter, BBC News

A test vaccine against Ebola could be given to healthy volunteers in the UK in September, according to an international health consortium.

The trial will start as soon as ethical approval is granted, experts at the Wellcome Trust say.

If the vaccine works well, the study will extend to The Gambia and Mali.

The World Health Organization (WHO) says the virus could affect 20,000 people during this outbreak which is expected to continue for many months.

Global outbreak
The latest figures show that more than 1,550 people have died from the virus, with more than 3,000 confirmed cases - mostly in Guinea, Liberia and Sierra Leone.

Researchers hope the vaccine will prevent people from catching the disease in these countries, but will first test the medicine in unaffected populations.

The vaccine consists a single Ebola virus protein which triggers an immune response once it enters the body - but they say this cannot cause anyone who is given it to become infected.

In the first part of the study it will be trialled on 60 healthy volunteers and if shown to be safe and working well it will then be administered to 80 volunteers in The Gambia and Mali.

The vaccine could then start to be offered more widely in affected countries during 2015.

'Future epidemics'
Dr Jeremy Farrar, director of the Wellcome Trust, said: "This epidemic has shown how difficult it can be to control Ebola.

"How useful drugs and vaccines might be in complementing existing public health interventions can only be assessed in epidemics.

"The initial safety work we're announcing with our international partners will hopefully make that possible during this crisis and for inevitable future epidemics."

Dr Moncef Slaoui, at GlaxoSmithKline, the company working on the vaccine, said: "Developing a new vaccine is complex with no guarantees of success and it is still early days for our Ebola vaccine candidate.

"But we are encouraged by progress so far and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to the control of this or future Ebola outbreaks."

The vaccine study, led by scientists at the University of Oxford, is planned to run alongside similar trials in the United States.

Adverts requesting volunteers will appear in local papers and on social media, the researchers say.

Each volunteer will be given one dose and be followed up for six months to check for any side-effects.

The Wellcome Trust, the UK Department for International Development and the Medical Research Council are providing a £2.8m grant for this project.

line
Ebola Virus Disease (EVD)
A fruit bat is pictured in 2010 at the Amneville zoo in France.
Fruit bats are believed to be a major carrier of the Ebola virus but do not show symptoms
Symptoms include high fever, muscle pain, bleeding and intense weakness
Fatality rate can reach 90% - but current outbreak has mortality rate of about 55%
The virus is spread through close contact with the bodily fluids of infected individuals
There is no proven vaccine or cure
Supportive care such as rehydrating patients who have diarrhoea and vomiting can help recovery
Fruit bats, a delicacy for some West Africans, are considered to be virus's natural host

http://www.bbc.com/news/health-28966419

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 12:33 pm 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
Feds to begin testing Ebola vaccine on humans
Image
Photo by: (AP Photo
This Aug. 12, 2014 file photo shows a healthcare worker walking near a Ebola isolation unit wearing protective gear against the virus at Kenema Government Hospital in Kenema, Sierra Leone. Federal researchers next week will start testing humans with an experimental vaccine to prevent the deadly Ebola virus. The National Institutes of Health (NIH) announced Thursday that it is launching the safety trial on a vaccine developed by the agency’s National Institute of Allergy and Infectious Diseases and GlaxoSmithKline.
1
Thursday, August 28, 2014
Lindsay Kalter


US To Begin Safety Testing Ebola Vaccine...
Federal researchers next week will start testing humans with an experimental vaccine to prevent the deadly Ebola virus. The National Institutes of Health...


The National Institutes of Health announced today that it will begin testing an Ebola vaccine on humans starting next week — efforts that were expedited in response to the outbreak tearing through West Africa.

“We have accelerated the timeline for testing experimental Ebola vaccines that we have been developing for several years,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the NIH, during a phone conference today.

The study is “the first step in developing a vaccine that could be licensed and used in the field to protect not only front-line health care workers, but those living in areas where Ebola virus exists,” he said, adding that the escalating situation requires an “all-hands-on-deck response.”

The vaccine is being developed by the NIAID in collaboration with health care company GlaxoSmithKline and the United States Army Medical Research Institute for infectious diseases.

The vaccine performed “extremely well” when tested on monkeys, Fauci said.

Fauci said the first three volunteers will be enrolled in the study next week, and the trial will eventually enroll 20 adults ages 18-50. The study will be conducted at NIH headquarters in Bethesda, Md.

NIH will likely have the results of the study before the end of the calendar year. Fauci said that it is impossible to know at this time whether the battle against the current outbreak will benefit from it.

“The options are really going to depend on the real-time evolution of what’s going on on the ground,” he said. “We need to take it in a stepwise fashion and focus on public health measures.”

The death toll in West Africa has exceeded 1,500, according to the World Health Organization.

http://bostonherald.com/news_opinion/lo ... _on_humans

_________________
www.twitter.com/hniman


Top
 Profile  
 
PostPosted: Thu Aug 28, 2014 12:35 pm 
Offline

Joined: Wed Aug 19, 2009 10:42 am
Posts: 56044
Location: Pittsburgh, PA USA
Published: Thursday August 28, 2014 MYT 11:30:02 PM
Updated: Thursday August 28, 2014 MYT 11:31:04 PM
Wanted: 60 volunteers to test Ebola vaccine in middle England

BY BEN HIRSCHLER

LONDON (Reuters) - Fancy testing an Ebola vaccine? It may sound scary but the scientist behind the British trial of a shot that has so far only been given to monkeys sees little risk and is optimistic he will drum up enough volunteers.

Adrian Hill, director of the Jenner Institute at the University of Oxford, needs 60 healthy individuals in the university town aged 18 to 50 to take part in the study of the experimental vaccine from GlaxoSmithKline.

Given mounting alarm at the world's worst outbreak of the disease, which has killed more than 1,500 people in West Africa, GSK and researchers in Britain, the United States and Africa have decided to fast-track clinical testing.

That means Hill needs to pull out the stops to get volunteers on board by the target start date of mid-September.

"I think the chances are pretty good of recruiting enough people on time," Hill told Reuters. "We're going to be encouraging healthcare staff in particular to volunteer - and we have a very large hospital in Oxford."

Others, including university students, may also take part - and all those participating will be entitled to a payment to compensate them for their time, since the trial will involve nine visits over six months, as well as a single injection.

The compensation is likely to be in the "low hundreds" of pounds, although the final figure has yet to be set by the ethical committee looking after this particular study.

"It won't make anyone rich," Hill said. He wanted volunteers who believed in the project rather than those needing the money.

Healthcare workers are an obvious choice, he believes, since the World Health Organisation says they are a group that could benefit from the early emergency deployment of a vaccine.

The aim of the so-called Phase I trial is to assess safety and immune responses, so Hill will be on the look-out for side effects such as sore arms or fevers the day after injection.

He is not worried that any of the subjects will catch Ebola, since the vaccine contains no infectious Ebola virus material.

The only Ebola component is a gene for a protein that sits on the virus’s surface - and that protein does not cause illness. The vaccine is nothing like more familiar vaccines, such as for mumps and rubella, which contain the actual virus.

The Jenner Institute vaccinates 2,000 people a year in clinical trials and has played a leading role in testing other vaccines that consist of a common cold virus, called an adenovirus, that has been engineered to carry inserted genes.

All such vaccines have had a good safety record in early-stage trials for diseases including malaria, tuberculosis and HIV, although none has yet made it to market, Hill said.

(Additional reporting by Sharon Begley in New York; Editing by Giles Elgood)

http://www.thestar.com.my/News/World/20 ... e-England/

_________________
www.twitter.com/hniman


Top
 Profile  
 
Display posts from previous:  Sort by  
Post new topic Reply to topic  [ 17 posts ]  Go to page 1, 2  Next

All times are UTC - 5 hours [ DST ]


Who is online

Users browsing this forum: Google [Bot], Yahoo [Bot] and 9 guests


You cannot post new topics in this forum
You cannot reply to topics in this forum
You cannot edit your posts in this forum
You cannot delete your posts in this forum
You cannot post attachments in this forum

Search for:
Jump to:  
cron
Powered by phpBB® Forum Software © phpBB Group