Ebola vaccine promising in first human trials: NIH

WASHINGTON - Researchers say they are one step closer to developing an Ebola vaccine, with a Phase 1 trial showing promising results, but it will be months at the earliest before it can be used in the field.

The news comes amid the worst ever outbreak of the hemorrhagic fever, which has killed 5,500 people so far, mostly in West Africa.

Pharmaceutical companies and health agencies scramble to fast-track experimental drugs and vaccines that could help.

In the first phase of testing, all 20 healthy adults injected with a higher or lower dose of the vaccine developed antibodies needed to fight Ebola, said the National Institutes of Health (NIH), which conducted the study.

Results were published Wednesday in the New England Journal of Medicine.

"The unprecedented scale of the current Ebola outbreak in West Africa has intensified efforts to develop safe and effective vaccines," said Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, which is developing the vaccine alongside GlaxoSmithKline.

The vaccines under development "may play a role in bringing this epidemic to an end and undoubtedly will be critically important in preventing future large outbreaks," he noted.

"Based on these positive results from the first human trial of this candidate vaccine, we are continuing our accelerated plan for larger trials to determine if the vaccine is efficacious in preventing Ebola infection," he added.

But the NIAID/GSK vaccine is still a long way from being ready for use in the field.

The NIAID is "in active discussions with Liberian officials and other partners about next-stage vaccine testing in West Africa" for efficacy and safety, the NIH said, but no announcement on larger-scale trials was expected before early next year.

There is no licensed treatment or vaccine against the Ebola virus, which is transmitted through bodily fluids and has been fatal in an estimated 70 percent of cases in the current outbreak.

Antibodies within four weeks

The volunteers were injected starting in September, and each showed a positive result for Ebola antibodies in blood tests within four weeks.

The 10 volunteers in the higher-dose group developed higher antibody levels, the NIH said.

In addition, two of the lower-dose group and seven of the higher-dose group developed a kind of immune cell called CD8 T cells, which are an important part of the body's response against disease.

"We know from previous studies in non-human primates that CD8 T cells played a crucial role in protecting animals" who got the vaccine and then were exposed to Ebola, said researcher Julie Ledgerwood, the trial’s principal investigator.

None of the volunteers experienced serious side effects within the study period, though two had a brief, mild fever within the 24 hours after the injection.

The vaccine uses a modified chimpanzee cold virus to deliver segments of genetic material from the Ebola virus.

The genetic material cannot spread in the body like the virus does, but can still prompt the antibody response.

The version tested at NIH contains material from two species of Ebola -- the Zaire species, responsible for the outbreak in West Africa, and another called Sudan Ebola.

"This work is encouraging and another significant contribution to efforts to tackle the Ebola crisis," said Dr Jeremy Farrar, Director of the Wellcome Trust.

The White House also congratulated the vaccine researchers.

"We congratulate Drs Francis Collins and Tony Fauci and their teams at the National Institutes of Health on the first published results from Phase 1 clinical trials of a promising Ebola vaccine candidate," a White House statement said, adding that President Barack Obama would visit the NIH next week.

A second version of the vaccine, aimed at blocking just Zaire Ebola, also began human testing in October, at the University of Maryland.

Another experimental vaccine that has shown promising results in primates is the Canadian VSV-EBOV, licensed by US firm NewLink Genetics. It is also in early stages of human testing.

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Americans 'can't give in to hysteria or fear' over Ebola: Obama

WASHINGTON - With three cases of Ebola diagnosed in the United States but more than 100 people being monitored in case they contract the disease, President Barack Obama urged Americans on Saturday not to give in to "hysteria" about the spread of the virus.

As though to illustrate his point, a Dallas bus and train station was closed on Saturday afternoon over concern about a woman who fell ill. The woman was first reported to be on the checklist for possible Ebola exposure, but then turned out not to be on any such list.

Obama made plain he is not currently planning to give in to demands from some lawmakers for a ban on travelers from the worst-hit countries.

"We can't just cut ourselves off from West Africa," Obama said in his weekly radio address. "Trying to seal off an entire region of the world - if that were even possible - could actually make the situation worse," he said.

The worst Ebola outbreak on record has killed more than 4,500 people, most of them in the West African countries of Liberia, Sierra Leone and Guinea.

Obama, whose approval rating is already low, has been criticized over his administration's handling of Ebola. He held a flurry of meetings on the issue in the past week and on Friday appointed Ron Klain, a lawyer with long Washington experience, to oversee the effort to contain the disease.

Republicans questioned why he did not pick a medical expert.

"I hope he (Klain) is successful in this. I think it's a step in the right direction, but I just question picking someone without any background in public health," Republican Representative Ed Royce, chairman of the House Foreign Affairs Committee, told CNN on Saturday.

The Obama administration is not alone in facing criticism. The World Health Organization has been faulted for failing to do enough to halt the spread since the outbreak was detected in March.

The agency promised it would publish a full review of its handling of the crisis once the outbreak was under control, in response to a leaked document that appeared to acknowledge that it had failed to do enough.

There is no cure or approved vaccine yet for Ebola but pharmaceutical companies have been working on experimental drugs. The virus is transmitted through an infected person's bodily fluids and it is not airborne.

Canada said on Saturday it would ship 800 vials of its experimental Ebola vaccine, undergoing clinical trials, to the WHO in Geneva, starting on Monday. Iowa-based NewLink Genetics Corp holds the commercial license for the Canadian vaccine.

Britain's biggest drugmaker GlaxoSmithKline said on Saturday that work to develop a vaccine was moving at an "unprecedented rate" and the next phase - if successful - involving vaccinating frontline healthcare workers, would begin early 2015.

RASH OF SCARES

Obama sought to put the extent of the disease in the United States in perspective. "What we're seeing now is not an 'outbreak' or an 'epidemic' of Ebola in America," he said. "This is a serious disease, but we can't give in to hysteria or fear."

A rash of Ebola scares has hit the country since late September when a Liberian visitor to Dallas, Texas, became the first person to be diagnosed in the United States. Americans' faith in the medical system and in authorities' ability to prevent the disease from spreading was jolted by a series of mis-steps when the Liberian was initially not diagnosed by a Dallas hospital.

The man, Thomas Eric Duncan, was admitted to Texas Health Presbyterian Hospital days later and diagnosed with Ebola. Two nurses who were part of the team caring for Duncan, who died on Oct. 8, contracted Ebola. Amber Vinson is being cared for at Atlanta's Emory University Hospital, while Nina Pham is being treated at the National Institutes of Health (NIH) just outside Washington.

A chain of people who had contact with either Duncan or the sick nurses are being monitored in case they develop the disease, which has an incubation period of up to 21 days.

The Texas Department of State Health Services said in a statement on its website dated Saturday that it was working to monitor people who had contact with the Ebola patients, specimens, or potentially contaminated surfaces. A total of 145 "contacts and possible contacts" were being monitored for symptoms, while 14 people had completed surveillance, it said.

Some 800 passengers who took the same planes as Vinson on a trip she made to Ohio before being diagnosed, and passengers on subsequent flights using the same planes, have been contacted by the airline, Frontier Airlines, the carrier said on Saturday.

The airline said in a letter to employees that it had been informed by the U.S. Centers for Disease Control and Prevention (CDC) that the Dallas nurse may have been in a more advanced stage of the illness than previously thought, when she traveled back to Dallas from Cleveland on Oct. 13.

The White House said late on Friday it would send senior personnel to Dallas to help federal, state and local officials there trying to identify and monitor people who came in contact with the three people who fell sick with Ebola.

Those being monitored include a lab worker at the Dallas hospital, who is not ill but is in isolation at sea: in her cabin on the Carnival Magic cruise ship. The lab worker did not have contact with Duncan, but may have come in contact with test samples.

Her presence on the ship caused Mexican authorities to deny docking at the Mexican port of Cozumel on Friday. The Carnival Magic, owned by Carnival Corp unit Carnival Cruise Lines, was en route back to Galveston on Sunday.

At Dallas' White Rock station, a woman was taken to the hospital for evaluation on Saturday, the city's transit authority said. Local media reported the station was closed as she was being monitored for possible Ebola exposure, but the Dallas Area Rapid Transit system said she was not on a watchlist.

Obama has stressed that containing Ebola should include help for the worst-hit countries and Washington plans to deploy up to 4,000 military personnel to the region by late October. Obama is preparing to ask for additional funds from Congress to beat Ebola, and could make the request next week, according to a Bloomberg report.

British Prime Minister David Cameron said on Saturday European Union leaders should raise the amount of money pledged to fight Ebola to 1 billion euros ($1.3 billion) and mobilize at least 2,000 workers to head to West Africa.

He made the appeal in a letter to the President of the European Council Herman Van Rompuy. A spokeswoman at Cameron's office said the EU commission and 28 member states had pledged a total of 500 million euros so far to fight Ebola.

Combatting the disease was also among the subjects of talks being held on Friday and Saturday between American and Chinese top diplomats.

(Additional reporting by Mohammad Zargham and Eric Beech in Washington, Frank McGurty in New York, Anna Driver in Dallas, Tom Miles in Geneva, and Costas Pitas in London; Writing by Frances Kerry and Megan Davies; Editing by David Clarke and Grant McCool)

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