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Information on vaccines to counter Ebola and other diseases

The Mission of this group is to follow the development of vaccines and other medications to counter Ebola and other diseases.

Members

Kathy Gilbeaux mdmcdonald MDMcDonald_me_com mike kraft

Email address for group

vaccines_global@m.resiliencesystem.org

Liberians overcome fear to volunteer for Ebola vaccine trial

ASSOCIATED PRESS  by Jpnathan Paye-Layleh             March 22, 2015

MONROVIA, Liberia — Liberians are overcoming their fears of Ebola to volunteer for a vaccine trial...

One year after the World Health Organization declared the Ebola outbreak, vaccine trials are under way in Liberia and Guinea. Sierra Leone will start a trial later this month.

In Liberia, scientists have fanned out across the country to explain the studies and reduce the fear and confusion that have stymied efforts to contain Ebola.

Dr. Stephen Kennedy, the Liberian lead investigator for the study, was among the first people to volunteer for the vaccine trial, getting his injection in front of the media. Similarly, in Guinea, authorities started the study by injecting a series of prominent officials, including the head of the country's Ebola response.

The outreach worked in Liberia, where more than 700 people have volunteered, well beyond the 600 required, according to Kennedy.

Read complete story.
http://news.yahoo.com/liberians-overcome-fear-volunteer-ebola-vaccine-trial-120848405.html

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FDA panel to discuss Ebola vaccine development in May

REUTERS                                                    March 18, 2015

WASHINGTON ==The U.S. Food and Drug Administration said an advisory panel will discuss the development of Ebola vaccines, days after an American health worker was flown back after being tested positive for Ebola in Sierra Leone.

The federal health regulator would discuss the development of vaccines on May 12, it announced on its website on Wednesday.

The resurgence of the virus last year prompted drugmakers from across the world to develop new treatments that are in different stages of studies....

The World Health Organization said it will decide on mass vaccination against the virus in August.

See full story.

http://www.reuters.com/article/2015/03/18/us-health-ebola-fda-idUSKBN0ME1D520150318
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See Federal Register notice of meeting.

https://www.federalregister.gov/articles/2015/03/17/2015-06116/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting

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Ebola vaccine trial to combine GSK, Emergent Bio shots

REUTERS                                                                                                          March 16, 2015

LONDON  - Scientists are to test a new two-shot Ebola vaccine using an experimental shot from Britain's GlaxoSmithKline, which is already in clinical trials in Africa, and a new kind of booster from Emergent BioSolutions.

A health worker, left, injects a man in his arm with an Ebola vaccine in Conakry, Guinea, March 7, 2015. The World Health Organization is starting large-scale testing of an experimental Ebola vaccine in Guinea  to see how effective it might be in preventing future outbreaks of the deadly virus.  (AP Photo/ Youssouf Bah)

The Maryland-based biotech company said on Monday its modified vaccinia Ankara (MVA) Ebola Zaire vaccine would be used in an initial Phase I clinical study to be conducted by researchers at the University of Oxford.

Although Ebola case numbers have fallen to a low level, drug companies are still pushing ahead with efforts to develop an effective vaccine, which may help fight the next outbreak, even if it does not come in time for the current epidemic.

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Vaccines Face Same Mistrust That Fed Ebola

NEW YORK TIMES  by and         March 14, 2015

MONROVIA, Liberia — West Africa’s Ebola epidemic may be waning, but another outbreak in the future is a near certainty, health officials say.

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Lack of Ebola Cases Shifts Vaccine Trials Away From Liberia

TIME MAGAZINE  by Alexandra Sifferlin                                                                        March 13, 2015

The National Institutes of Health (NIH) may relocate its clinical trials of Ebola vaccines to Guinea, since there are no longer enough Ebola cases in Liberia for a proper efficacy trial.

On Feb. 2, the NIH launched an initial safety trial for two vaccines to protect against Ebola in Liberia. The plan was to test 600 people for overall safety and then launch a second phase of the trial in 27,000 people to see whether or not the vaccine prevents infection with Ebola virus compared to a placebo.

The safety test was successfully completed the week of March 9—but around the same time, Liberia announced that it had released its last confirmed patient from its Ebola treatment centers. ...

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New Ebola drug trial starts in Sierra Leone

SCIENCE By Kai Kupferschmidt                                                                       March 11, 2015

Researchers in Sierra Leone today started a new phase II trial of an experimental drug in Ebola patients. The first participant received an injection of the therapeutic, called TKM-Ebola, this morning at an Ebola treatment unit in Kerry Town. The trial may expand to other sites; the study team hopes to have an answer fast so that it can either move on to another drug or start a phase III study of TKM-Ebola.

Produced by Tekmira Pharmaceuticals in Burnaby, Canada, TKM-Ebola is made of synthetic, small interfering RNAs packaged into lipid nanoparticles. The RNAs target three of Ebola’s seven genes, blocking the virus’s replication. TKM-Ebola has been shown to work well in monkeys; the efficacy trial in humans is only starting now because there was not enough of the drug available earlier. Also, the RNAs have been adapted to the strain circulating at the moment.

The study does not have a placebo arm; all patients at the trial site are eligible for the drug, and researchers hope to determine whether it works by comparing them with patients treated elsewhere.

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Why we’re still waiting on an Ebola vaccine

Researchers are scrambling to start trials before the outbreak fades, but establishing faith in vaccines will take time

AL JAZEERA AMERICA  by

FREETOWN, Sierra Leone — Since Ebola hit this coastal city last summer, nurses at Connaught Hospital have put their lives on the line by working with patients at risk of the deadly disease. Now researchers aim to recruit them as well as ambulance drivers and other hospital staff as subjects in one of the largest Ebola vaccine trials to date.

But just a few weeks before the trial begins enrollment, many health care workers are voicing discomfort about the shot. “It would be really good to have a vaccine, but we’re scared because it’s new,” said Kadiatu Nubieu, a nurse at Connaught.

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First look at hospitalized Ebola survivors' immune cells could guide vaccine design

MEDICALXPRESS                                                                                                 March 9, 2015
Researchers from Emory and the Centers for Disease Control and Prevention have now obtained a first look at the responses in four Ebola disease survivors who received care at Emory University Hospital in 2014, by closely examining their T and B cells during the acute phase of the disease. The findings reveal surprisingly high levels of , and have implications for the current effort to develop vaccines against Ebola.

The Ebola virus, isolated in November 2014 from patient blood samples obtained in Mali. The virus was isolated on Vero cells in a BSL-4 suite at Rocky Mountain Laboratories. Credit: NIAID

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A Mishap Sheds Light on an Ebola vaccine

NEW YORK TIMES  by Denise Grady                                                                March 6, 2015

The moment he felt a needle jab into his thumb in September on an Ebola ward in Sierra Leone, Dr. Lewis Rubinson knew he was at risk of contracting the deadly disease. What could he do but wait to see if he got sick, and hope that treatment would pull him through?

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Guinea to start final trials of Ebola vaccines this week

REUTERS by Kate Kelland and Tom Miles                      March 5, 2015

LONDON/GENEVA --Final stage trials of an Ebola vaccine being developed by Merck and NewLink Genetics will begin in Guinea on March 7, the World Health Organization said on Thursday.

Signaling global health authorities' determination to see through trials despite a sharp drop in cases in the West Africa epidemic, the WHO said a second shot, developed by GlaxoSmithKline will be tested "in a sequential study, as supply becomes available".

All three worst-hit countries - Guinea, Liberia and Sierra Leone - aim to conduct final-stage trials of vaccines, and Liberia is already testing the GlaxoSmithKline and Merck-NewLink shots, while Sierra Leone is expected to announce plans soon.

But recent steep declines in new Ebola cases will make it far harder to prove whether experimental vaccines work, as the vaccine's effect will be difficult to establish.

The WHO, however, said it was committed to pushing ahead.

Read complete story.
http://www.reuters.com/article/2015/03/05/us-health-ebola-vaccine-idUSKBN0M10ZD20150305

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