First Ebola vaccine trial starts in Africa with three health workers given experimental drug

The first Ebola drug trial in Africa has started with three healthcare workers in Mali receiving an experimental vaccine.

It comes as the World Health Organisation (WHO) at the weekend warned that  the virus was now ‘entrenched’ in the capital cities of the three worst-hit countries, and accelerating in almost all settings.

The trial started on October 8, with the first health worker receiving the drug, followed by two colleagues.

Over the course of the trial, 37 more healthcare workers will be given the vaccine.

It is the latest vaccine to be rushed into clinical trials as the worst-ever Ebola outbreak grips West Africa.

The WHO said the disease has so far claimed the lives of more than 3,800 people, infecting at least 8,000 people in West Africa.

The organisation’s deputy head Bruce Aylward warned that the world’s response is not keeping up with the disease in Guinea, Liberia and Sierra Leone – the three worst-hit nations.

Yesterday African leaders chided the international community for its slow response to the epidemic and appealed to the world to turn promises of aid into action on the ground.

In emotional appeals to a high-level meeting of major donors gathered at the World Bank, the leaders of Sierra Leone, Guinea and Liberia, said they needed everything from treatment centres to healthcare workers, equipment and funding.

Prof. Myron Levine, from the University of Maryland School of Medicine, who helped developed the experimental drug, said if successful the trial ‘could alter the dynamic’ of the current outbreak.

While the university’s dean Albert Reece, said the research ‘will play a key role in helping solve’ the crisis.

UK firm design ‘fast and simple’ Ebola screen test

Scientists at a British company say they have come up with a test to fight the Ebola epidemic.

Experts at Primerdesign Ltd said it has developed a fast and simple way to screen suspected victims. They say the kit detects the DNA fingerprint of the Ebola Virus in the blood in just 90 minutes and is ‘affordable’ and ‘easy to use’.

The firm is now in talks with the World Health Organisation about plans to roll out large numbers to the frontline in West Africa as soon as possible.

Doctor Jim Wicks, managing director of Primerdesign, a spin-off company from the University of Southampton, said it meets an ‘urgent’ need.

Dr Wicks said: ‘Accurate diagnostics is essential in controlling an outbreak like Ebola. ‘There is an urgent need for rapid testing to screen suspected patients and people travelling in and out of the region. Our test is quick, affordable and easy to perform.’

By picking up minute quantities of the disease in the early stages, the kit makes pre-emptive healthcare intervention possible. It works on the principle that viruses all have a unique genetic fingerprint, like humans, only its encoded in RNA (Ribonucleic acid) rather than DNA.

A blood sample is taken from the patient before RNA is extracted, placed in a tube with the kit’s ingredients and run through a machine. The result is ready within 90 minutes.

‘Without you we can’t succeed, without your quick response a tragedy unforeseen’.

Prof. Levine, said: ‘This research will give us crucial information about whether the vaccine is safe, well tolerated and capable of stimulating adequate immune responses in the highest priority target population, health care workers in West Africa.’

‘If it works, in the foreseeable future it could help alter the dynamic of this epidemic by interrupting transmission to health care and other exposed front-line workers.’

The drug consists of an adenovirus (cold virus) that does not cause illness in humans. It has been modified so it can’t multiply in humans, but produces a single attachment protein of Ebola virus.

The body’s immune responses against this single Ebola protein have been found to be highly protective in studies carried out on animals, researchers said.

Prior to September the vaccine had only been tested in animals.

A second trial on African soil is expected to begin soon in the Gambia, to run in parallel with the Mali study.

Ordinarily it would take between six to 11 months to obtain the necessary ethical, technical and administrative approvals to move from animal vaccine trials to one in a developing country, where subjects are at risk of the natural disease.

But the consortium behind the vaccine study worked in unison to achieve the goal in two months.

Prof. Samba Sow, director general of Mali’s centre for vaccine development said: ‘This is just the critical first step in a series of additional clinical trials that will have to be carried out to fully evaluate the promising vaccine.

‘However, if it is eventually shown to work and if this information can be generated fast enough, it could become a public health tool to bring the current, and future, Ebola virus disease epidemics under control.’

And Dr Milagritos Tapia, the clinical investigator overseeing the trial in Mali, added: ‘’Malian health care workers are showing keen interest in participating in the clinical trial to help evaluate this vaccine.’’

Praising the work of the scientists involved, Dean Albert Reece of the University of Maryland, said: ‘Ebola is among the most urgent international public health issues we are facing.

‘This research will play a key role in helping to solve it… (the scientists) have done an extraordinary job, and are working hard to contribute their expertise to the worldwide effort to fight this virus.’

But it is likely to be months before any effective vaccine will be made available.

And in the first instance, any small quantities produced, would be given to healthcare workers on the front line fighting the disease.

It is hoped the move will help encourage doctors, nurses and other health workers – who are at highest risk of becoming infected – to join the fight against the disease in West Africa.

The vaccine was developed at the U.S. National Institute of Allergy and Infectious Diseases.

Ebola vaccine trials are also underway in the UK, led by Oxford University and the Wellcome Trust, and in the U.S., at the National Institutes of Health.

While Mali is yet to succumb to the spread of the vicious disease, experts say it is vital vaccines are trialed in Africa.

Meanwhile, Federal health officials in the United States (U.S.) admitted on Sunday they were deeply concerned by a “breach in protocol” after it was revealed that a healthcare worker who treated Thomas Eric Duncan in Dallas had become the second person to be diagnosed with Ebola in the U.S.

Four days after Duncan died in an isolation unit, after arriving in Dallas last month from Liberia, secondary tests confirmed that a female employee at Texas Health Presbyterian hospital has the virus, in the first case of Ebola transmission in the U.S. and the second outside Africa.

Texas officials earlier said preliminary tests showed the worker had been exposed to Ebola, but they were awaiting confirmation from the Centers for Disease Control and Prevention (CDC). Confirmation followed on Sunday afternoon.

The White House said President Barack Obama had been updated about the case.

Hospital officials said the employee had worn full protective clothing during all contact with Duncan. Dr Tom Frieden, the CDC director, warned in a media briefing on Sunday that other hospital staff could also have been exposed to the virus and may show symptoms in the coming days.

“The healthcare workers who cared for this individual may have had a breach of the same nature,” Frieden said. “It is certainly very concerning and it tells us there is a need to enhance training and make sure protocols are followed.

“The protocols work … but we know that even a single lapse or breach can result in infection.”

The White House said Obama had asked the CDC to move as quickly as possible in investigating the apparent breach of infection control procedures, and told federal authorities to take more steps to make sure hospitals and healthcare providers are ready to follow the proper procedures in dealing with an Ebola patient.

The woman infected by Ebola in Dallas, who was identified in media reports as a nurse, treated Duncan after he fell gravely ill and was admitted to hospital on 28 September, his second visit to the hospital.

Hospital chief clinical officer Dr Daniel Varga said in a statement: “Individuals being monitored are required to take their temperature twice daily. As a result of that procedure, the caregiver notified the hospital of imminent arrival and was immediately admitted to the hospital in isolation.

“The entire process, from the patient’s self-monitoring to the admission into isolation, took less than 90 minutes. The patient’s condition is stable.”

The Texas health commissioner David Lakey said the test that confirmed the woman’s infection was conducted in a laboratory in Austin and came back positive on Saturday evening, but showed lower levels of the virus than in Duncan’s case.

“It’s deeply concerning that this infection occurred,” Frieden said. “We can’t let any hospital let its guard down.”

The woman was not among the 48 people officials are monitoring during the virus’s 21-day incubation period who may have contact with Duncan and are so far asymptomatic. Lakey said health officials were working to identify people who may have had contact with her once she started showing symptoms and as a result became contagious.

Frieden said that so far they had found only one such person, who was “under active monitoring”, but “it is possible that other individuals were exposed”.

He said that the woman had “extensive contact … on multiple occasions” with Duncan following his second visit to the hospital, where he was admitted and isolated.

Teresa Romero, a 44-year-old Spanish nurse, contracted Ebola after caring for a priest who had been repatriated from west Africa. She is being treated in a Madrid hospital and has told El Pais that she believes she may have made a mistake when taking off her protective suit, perhaps touching her face with her gloves.

Frieden said the second patient in Dallas has been interviewed but so far “that worker has not been able to identify a specific breach” which may have resulted in her exposure. The CDC said that on Friday the worker, who had been self-monitoring for Ebola symptoms, reported a low-grade fever and was referred for testing. She was promptly isolated, officials said.

CDC chief, Tom Frieden at a news conference in Atlanta. Photograph: John Amis/AP.

After a series of missteps in Duncan’s case, federal and Texas officials have sought to quell public fears about the threat of the virus and the ability of government agencies to contain it.   But news that one of its workers has contracted Ebola despite taking precautions puts the hospital under further pressure.

On September 26, Duncan went to the hospital for treatment but was sent away with antibiotics after hospital staff seemingly failed to consider that he might have Ebola despite being made aware of his travel history. Medical records obtained by the Associated Press indicated that Duncan was feverish with a temperature of 103F on that visit. He then fell gravely ill and was rushed to the hospital on 28 September, where he was isolated. His diagnosis was confirmed on 30 September.

He was staying with Louise Troh, his partner, in an apartment less than a mile from the hospital. Relatives of Duncan’s family have indicated in statements to the media that they are unhappy with the hospital’s failure correctly to diagnose the 42-year-old during his first visit and dissatisfied with the standard of treatment he received once the case was confirmed. They are believed to be considering legal action against the hospital.

After being criticised for their sluggish response to Duncan’s diagnosis, which left several quarantined family members stuck in the apartment for several days before they were taken to a home at an undisclosed location and a hazardous-materials cleaning crew arrived to decontaminate the unit, Dallas officials were at pains in a Sunday morning media briefing to stress they have acted more decisively this time to clean and control access to the nurse’s residence.

Mayor Mike Rawlings said a team “has cleaned up the common areas and decontaminated the common areas and decontaminated any of the open areas of an apartment complex … they sprayed with a decontaminant, a clean-up agent and right now police are standing by to make sure no one enters. Furthermore, we have knocked on every door in that block and helped every single person who came to the door, explained what has happened.”

Rawlings also said a pet was believed to be inside the health worker’s apartment, but was not believed to be exhibiting signs of Ebola and would be taken care of. This week, a dog belonging to the Spanish nurse infected with the disease was destroyed.

Rawlings said that reverse 911 calls had been made to nearby residents to inform them of the diagnosis and that officials would return to knock on doors again on Sunday and talk to any people they had missed. Printed materials were left at every door, Rawlings said.

Media images showed a police officer blocking the entrance to a small apartment building less than four miles northeast of downtown Dallas and four miles south of the hospital where Duncan died. Similar images showed a yellow barrel containing hazardous waste sitting on the front lawn of the building.

A neighbour, Cliff Lawson, 57, told Reuters he was woken at 6am by two Dallas police officers, who told him “don’t panic”.

“I went back to bed after that. There’s nothing you can do about it. You can’t wrap your house in bubble wrap,” Lawson said.

During a briefing, Varga declined to provide a detailed timeline of events leading to the worker’s hospitalisation, citing patient privacy rights. He said the hospital was tracking 18 of its employees for possible exposure in the wake of Duncan’s admission and that the current patient had not been considered as high risk.

The hospital has a 24-bed intensive care unit which it is using exclusively as an Ebola care unit. Varga said the hospital was not accepting any more emergency patients.

Enhanced screenings of travellers arriving at five major US airports from Liberia, Sierra Leone and Guinea began at New York’s JFK on Saturday. Newark, Washington Dulles, Atlanta and Chicago O’Hare will follow suit on Thursday.

Meanwhile, Dr. Kent Brantly, a Samaritan’s Purse missionary from Texas who survived Ebola after contracting the deadly virus on a mission trip to Africa, spoke at a public forum at his alma mater, Abilene Christian University, sharing his experience with the disease and thoughts on the fear of Ebola.

“I am particularly thrilled to be alive,” Brantly, who contracted Ebola in Liberia while working as a missionary doctor but was eventually cleared from the disease, said at the Moody Coliseum at ACU, Texas, on Friday.

“There has been a lot of panic, a lot of – I hesitate to use word hysteria – around the events in Dallas,” Brantly said, alluding to Thomas Eric Duncan, the first person to be diagnosed with the Ebola virus in the United States.

Duncan died at Texas Health Presbyterian Hospital earlier this week. The Liberian national, who came to the U.S. to marry his fiancée weeks before he died, had not been given any experimental treatment – such as ZMapp or convalescent serum made from the blood of Ebola survivors.

Ebola – which can cause fever, vomiting and diarrhea – spreads through contact with bodily fluids such as blood or saliva. Since it began in West Africa in March, it has taken more than 4,000 lives.

“I just want to tell everyone that yes, Ebola is a serious devastating disease and for those number of people who have been identified as contacts of an Ebola patient, they need to be monitoring themselves, they need to be cooperating with the authorities, with the CDC, and it’s very serious for them, but for the rest of us we don’t need to be worried,” Brantly told the crowd.

While some accused Duncan of coming to the United States despite knowing that he had contracted the virus, the pastor of his American fiancée said Duncan was perhaps not aware of it.

“I think it’s very important for us to remember that he was not able to tell us about that personally or publicly,” Wilshire Baptist Church Senior Pastor George Mason, told The Christian Post earlier. “So any conclusions that we draw from that are really our own [and] not coming from him personally.”

Brantly said the decision to bring him from Liberia to the Emory University Hospital in Atlanta, Georgia, for treatment – which saved his life – was also criticised.

“I know there were a lot of people who didn’t want me to be brought back to America,” he recalled. “There were people who said some negative things about me or other people, and I just look at that and think, ‘Those people don’t know me, they’re not addressing these negative remarks at the person of Kent Brantly.’”

He said if he could say a word to Duncan’s family, he would express his “deepest sympathy.”

Brantly also urged help for West Africa.

“You’ve seen the news reports, and I can assure you, the reality on the ground in West Africa is worse than the worst report you’ve seen. And our attention and our efforts need to be on loving the people there,” he said.

“Let’s stop talking about that highly improbable thing and focus on saving people’s lives and stopping the outbreak where it is. God saved my life… He used some incredible people and unbelievable circumstances to do that … I want to live in that reality forever.”

Brantly said he knew he was probably going to die and had watched lots of other people die. “Here’s a drug that we don’t know if it’s going to work or not because we’ve never given it to a person before, but you’re probably going to die anyways, do you want to give it a shot? I said ‘yes.’”

He added that at this time, “I need to be a father to my children. They spent more than a month away from their dad wondering if he was going to die or not.”

Meanwhile, fears of an Ebola outbreak in the U.S. hit both coasts yesterday when health officials were dispatched to Los Angeles International Airport and a hospital in Boston to assess possible patients with the deadly virus.

Harvard Vanguard Medical Center in Braintree, Massachusetts was evacuated yesterday afternoon when a man, recently returned from Liberia, showed up at the facility complaining of head and muscle aches.

Just an hour later, a United Airlines flight that landed at LAX from New York’s JFK airport was diverted to a far terminal because of a passenger who had vomited and displayed flu-like symptoms.

It was later revealed that the Massachusetts patient does not in fact appear to have the deadly disease, but the man has been kept in isolation.

‘Out of an abundance of caution we immediately notified authorities and the patient was securely removed from the building and put into an ambulance now headed to Beth Israel Deaconess Medical Center,’ Ben Kruskal, chief of infectious disease at Harvard Vanguard Medical Associates, said in a statement.

‘The building was closed briefly but has now re-opened,’ the statement said.

Captain Jamie Moore of the Los Angeles Fire Department held a press conference shortly after the female passenger on flight that landed at LAX was assessed, and said there was ‘no reason to believe’ that she had been exposed to Ebola.

He says the woman most likely had some sort of ‘air illness’.

The alarm was raised however, because of the unidentified woman’s symptoms and the fact that she visited the Africa recently. But she had visited South Africa and    not the hot-spot nations in West Africa most plagued by the virus.

Captain Moore said that the fire department took the plane to a secluded terminal so as not to raise fears in the rest of the airport.

‘Unfortunately, we can’t control social media. And people began to tweet and people began to use Facebook and it created concerns that aren’t necessarily realistic concerns,’ Captain Moore said yesterday.

Yesterday, it was revealed that a Texas care worker has tested positive for the disease, making her the second person confirmed to have Ebola on U.S. soil.

Dr Tom Frieden, head of the Centers for Disease Control and Prevention, said the diagnosis shows there was a clear breach of safety protocol and all those who treated Thomas Eric Duncan are now considered potentially exposed.

The worker wore a gown, gloves, mask and shield while she cared for Duncan during his second visit to Texas Health Presbyterian Hospital, said Dr Daniel Varga of Texas Health Resources, which runs the hospital. Frieden said the worker has not been able to identify a specific breach of protocol that might have led to her being infected.

Mr. Duncan, who arrived in the U.S. from Liberia to visit family on Sept. 20, first sought medical care for fever and abdominal pain on Sept. 25. He told a nurse he had traveled from Africa, but he was sent home. He returned Sept. 28 and was placed in isolation because of suspected Ebola. He died Wednesday.

Liberia is one of the three countries most affected by the ongoing Ebola epidemic, which has killed more than 4,000 people, almost all of them in West Africa, according to World Health Organisation figures published Friday. The others are Sierra Leone and Guinea.

Texas health officials have been closely monitoring nearly 50 people who had or may have had close contact with Duncan in the days after he started showing symptoms.

The health care worker reported a fever Friday night as part of a self-monitoring regimen required by the CDC, Varga said. He said another person is in isolation, and the hospital has stopped accepting new emergency room patients. Frieden said officials are now evaluating and will monitor any workers who may have been exposed while Duncan was in the hospital.

‘We knew a second case could be a reality, and we’ve been preparing for this possibility,’ said Dr. David Lakey, commissioner of the Texas Department of State Health Services. ‘We are broadening our team in Dallas and working with extreme diligence to prevent further spread.’

Dallas officials knocked on doors, made automated phone calls and passed out fliers to notify people within a four-block radius of the health care worker’s apartment complex about the situation, though they said there was no reason for neighbors to be concerned.

Dallas police officers stood guard outside the complex Sunday and told people not to go inside. One said an industrial barrel outside contained hazardous waste taken from inside the building. Nearby residents periodically came out of their homes to ask about the commotion.

Kara Lutley, who lives a half-block from the complex, said she never received a call or other emergency notice and first heard about it on the news.

‘I’m not overly concerned that I’ll get Ebola,’ she said.

Officials said they also received information that there may be a pet in the health care worker’s apartment, and they have a plan in place to care for the animal. They do not believe the pet has signs of having contracted Ebola.

Frieden yesterday raised concerns about the possible breach of safety protocol and told CBS’ ‘Face the Nation’ that among the things CDC will investigate is how the workers took off protective gear, because removing it incorrectly can lead to contamination.

Investigators will also look at dialysis and intubation, in which a tube is inserted into a patient’s airway so a ventilator can help with breathing. Both procedures have the potential to spread infectious material.

Health care workers treating Ebola patients are among the most vulnerable, even if wearing protective gear.

A Spanish nurse assistant recently became the first health care worker infected outside West Africa during the ongoing outbreak.

Spread of a deadly plague: How will America contain Ebola? When is Ebola contagious?

Only when someone is showing symptoms, which can start with vague symptoms including a fever, flu-like body aches and abdominal pain, and then vomiting and diarrhea.

How does Ebola spread?

Through close contact with a symptomatic person’s bodily fluids, such as blood, sweat, vomit, feces, urine, saliva or semen. Those fluids must have an entry point, like a cut or scrape or someone touching the nose, mouth or eyes with contaminated hands, or being splashed. That’s why health care workers wear protective gloves and other equipment.

The World Health Organisation says blood, feces and vomit are the most infectious fluids, while the virus is found in saliva mostly once patients are severely ill and the whole live virus has never been culled from sweat.

The Texas Department of State Health Services said Sunday that a health-care worker who provided hospital care for the first patient to die from Ebola in the United States has tested positive for the virus. The worker was not identified and it was unclear what level of care the worker provided or when the health worker came into contact with the patient. If the diagnosis is confirmed, it would be the first known case of Ebola being transmitted in the U.S.

What about more casual contact?

Ebola isn’t airborne. Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, has said people don’t get exposed by sitting next to someone on the bus.

‘This is not like flu. It’s not like measles, not like the common cold. It’s not as spreadable, it’s not as infectious as those conditions,’ he added.

Who gets tested when Ebola is suspected?

Hospitals with a suspected case call their health department or the CDC to go through a checklist to determine the person’s level of risk. Among the questions are whether the person reports a risky contact with a known Ebola patient, how sick they are and whether an alternative diagnosis is more likely. Most initially suspicious cases in the U.S. haven’t met the criteria for testing.

How is it cleaned up?

The CDC says bleach and other hospital disinfectants kill Ebola. Dried virus on surfaces survives only for several hours.

She helped care for a missionary priest who was brought to a Madrid hospital. More than 370 health care workers in West Africa have fallen ill or died since the epidemic began earlier this year.

Ebola spreads through close contact with a symptomatic person’s bodily fluids, such as blood, sweat, vomit, feces, urine, saliva or semen.

Those fluids must have an entry point, like a cut or scrape or someone touching the nose, mouth or eyes with contaminated hands, or being splashed.

The World Health Organisation says blood, feces and vomit are the most infectious fluids, while the virus is found in saliva mostly once patients are severely ill. The whole live virus has never been culled from sweat.

Duncan, the first person in the U.S. diagnosed with Ebola, came to Dallas to attend the high school graduation of his son, who was born in a refugee camp in Ivory Coast and brought to the U.S. as a toddler when his mother successfully applied for resettlement.

The trip was the culmination of decades of effort, friends and family members said. But when Duncan arrived in Dallas, though he showed no symptoms, he had already been exposed to Ebola. His neighbors in Liberia believe Duncan become infected when he helped a pregnant neighbor who later died from it. It was unclear if he knew about her diagnosis before traveling.

Agency report adapted from DailyMailUK online, theguardianUK online and ChristianPost online

 

 

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