joi, 5 martie 2015

Doctor’s Mishap Sheds Light on Ebola Vaccine’s Effects



The moment he felt a needle jab into his thumb last 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?


Dr. Rubinson, an intensive-care specialist and associate professor at the University of Maryland School of Medicine, chose another option, described in an article and editorial published on Thursday in The Journal of the American Medical Association. He was quickly given a shot of an experimental vaccine, a type that had been used in only one other person. The hope was that if he had been exposed to Ebola, the vaccine would stimulate his immune system to fight off the virus.


As it turns out, it is not clear whether the vaccine could have protected him against Ebola, because blood tests indicate he was almost certainly never infected. It is clear, though, that the vaccine stirred up his immune system: He had fever, chills, nausea, muscle pains and a headache. But the symptoms ebbed after a few days, and when it was all over blood tests suggested that he was probably immune to Ebola.


Although it is impossible to draw broad conclusions from a single case, doctors said the information was nonetheless useful. There is hardly any other data on how the vaccine affects people, and knowing how Dr. Rubinson fared may help other health workers potentially exposed to Ebola decide whether to be vaccinated.


“In all likelihood, unfortunately, there will continue to be health care workers and others who have what are considered to be significant exposures to this potentially lethal virus,” said Dr. Mark J. Mulligan, a professor of medicine and infectious diseases at Emory University School of Medicine, and the senior author of the journal article.


The current outbreak has killed hundreds of doctors and nurses, mostly Africans. Ideally, Dr. Mulligan said, health workers would be vaccinated before they begin caring for Ebola patients. But until vaccines are approved and made widely available, he said, emergency treatment as in Dr. Rubinson’s case will be the best that doctors can offer to people who may have been exposed on the wards.


The vaccine given to Dr. Rubinson was made from another virus, V.S.V., for vesicular stomatitis virus, which causes a mouth disease in cattle but rarely infects people. V.S.V. has been used successfully in making other vaccines.


The vaccine was created by scientists from Canada and the United States about a decade ago, but its progress was stalled until recently, largely because drug companies have been reluctant to spend the huge sums needed to develop products useful mostly to poor countries.


Anticipating that a health worker might have a possible exposure, say from a needle stick or a breach in protective gear, doctors at Emory obtained a few vials of the vaccine from Canada. The idea would be to give the injection as soon as possible; waiting for symptoms to develop might be too late.


The plane that flew from the United States to pick up Dr. Rubinson brought the vaccine and he was given the shot before take off. The vaccine is not approved by the Food and Drug Administration, and Emory had to request special permission to offer it to him on an emergency basis.


But no one had any idea whether the vaccine would help, or whether it was even safe. Tests had shown it worked in monkeys, but it had been used in a person only once before, in 2009, when a lab worker in Germany was pricked by a needle. That worker never became infected.


The vaccine given to Dr. Rubinson came from another batch, produced somewhat differently, and he was the first person ever to receive it.


Since then, the vaccine has undergone safety testing in healthy people in the United States and other countries, and it is now being studied in a clinical trial in Liberia, but no information from that research has yet been published.


About 12 hours after Dr. Rubinson got the shot, while still in the air, he began to run a fever and shake with chills and sweats. It was exactly what he had been warned to expect as a reaction to the vaccine. The German lab worker had similar, but less intense symptoms.


After landing, Dr. Rubinson was taken by ambulance to the hospital at the National Institutes of Health in Bethesda, Md. He wrote an essay about his treatment for The American Journal of Tropical Medicine and Hygiene.


“I was under, like, seven blankets,” he said in an interview. “I was freezing, drenched, miserable.”


Though he knew he was almost certainly having a vaccine reaction, he also knew his symptoms matched those of Ebola, and he could not help wondering if he was infected.


“Everything played out exactly like we had thought,” he said. “But when you’re in the midst of it, you start to doubt.”


He took his temperature repeatedly with his own thermometer — it reached 103 degrees Fahrenheit — and checked his eyes in the mirror for telltale signs of hemorrhages.


His misery began to ebb after a few days, and he recovered fully. Blood tests found evidence of immunity to Ebola and a strong reaction to the vaccine — but no signs that he had ever been infected with Ebola.


“I think all those symptoms were from the vaccine,” Dr. Mulligan said. “The strongest conclusion is that he had never been infected with Ebola.”


Unpleasant as the symptoms are, Dr. Rubinson said, they are a small price to pay for someone at risk of Ebola.


Several other health workers with possible exposures have been given the vaccine since Dr. Rubinson was treated, Dr. Mulligan said. But he said he could not discuss their cases because of patient privacy rules.




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