Reasonable Rascal
Veteran Member
Volunteer Gets Experimental Ebola Vaccine
By Rick Weiss
Washington Post Staff Writer
Wednesday, November 19, 2003; Page A01
Steve Rucker, a registered nurse at the National Institutes of Health, broke with his lunchtime routine yesterday, forgoing his usual visit to the cafeteria and opting instead to roll up his sleeve for a shot filled with the biological essence of Ebola -- one of the world's deadliest and goriest diseases.
Surrounded by a gaggle of doctors and scientists, Rucker stepped into medical history at 12:10 p.m., becoming the first person ever injected with an experimental vaccine designed to protect against Ebola, the disease that was highlighted in the real-life thriller "The Hot Zone" and that continues to take a bloody toll in Africa.
"I've had better lunches," Rucker quipped as the shot's 100 trillion strands of synthetic DNA began to make their way into the cells in his arm.
Rucker is a pioneer in a high-tech effort to beat Ebola. If the vaccine works in people as it has in monkeys, it could fell one of the world's most horrid infectious scourges.
Alas, health officials say, despite weeks of advertisements and other pleas, only two people have volunteered to be part of the effort.
"People freak out about Ebola," said Margaret McCluskey, the director of nursing at the NIH's vaccine research center, where the new vaccine -- the first for Ebola -- awaits 25 more people to participate in initial safety tests.
When the NIH started testing an experimental vaccine for AIDS, many people with friends or lovers affected by that disease stepped forward. When it was for smallpox -- a disease feared these days as a weapon of bioterrorism -- a mix of patriotism and self-interest drew even more volunteers.
This time, however, the telephones are eerily silent. Almost no one, it seems, wants to
get an Ebola shot. Indeed, the only volunteer so far other than Rucker is a landscaper
who works in McCluskey's Silver Spring neighborhood.
"I basically raked him in," she conceded.
It is not surprising that people would hesitate about getting injected with anything
labeled "Ebola." The disease is notoriously lethal, rapidly killing 50 percent to 90
percent of its victims. Just the thought makes people irrational.
Already, the landscaper has been asked by some clients whether he is going to be
bringing the disease to the neighborhood.
The irony, scientists and doctors lament, is that this first Ebola vaccine is probably the safest and most sophisticated vaccine ever made, without a single component coming from the virus itself.
Indeed, the product spray-blasted into Rucker's arm (no needle necessary) is by any standard a marvel of biotechnological engineering. It was designed to rally the immune system even more than a real Ebola infection would, without causing any symptoms of the disease itself.
"It's remarkably sophisticated technology," said Gary Nabel, the virologist who is leading the Ebola effort in a fast-track program that has catapulted his basic research from the lab bench to the clinic in just three years.
Inexplicably, the frequency of Ebola outbreaks in Africa has been increasing. But it is not just Africans who will benefit, said Anthony S. Fauci, chief of the National Institute of Allergy and Infectious Diseases, which oversees NIH's vaccine research center. Like the smallpox virus and the bacterium that causes anthrax -- for which vaccines, though imperfect, at least exist -- Ebola virus, too, is a potential bioterrorism agent.
"In its natural form it's not the best," Fauci said. "You need close contact for it to spread. . . . But an aerosolized form would be extremely treacherous. And from a psychological terror aspect, you don't need a lot of people bleeding to get enormous terror in the population." The virus causes clotting abnormalities and tears holes in blood vessels, causing victims to bleed to death from multiple sites, including eyes, mouth and nose.
A vaccine, Fauci said, might deter those who would think about using such a weapon
and would be "a big cause of comfort" for citizens, who would know that protection is
available.
Rucker, 36, said he got religion about the importance of vaccines while living in
medicine-deprived parts of South America.
"It sounds funny to say I'm excited about an Ebola vaccine, but this really is an
exciting trial," he said. "It's so rare in research that you get to help with something
that's so promising. And the pharmaceutical industry would never do this. There's no
profit in this."
He has looked at the animal safety data and studied the informed-consent document
that spells out the risks -- which are largely limited to soreness around the injection
site.
"There's nothing in there about 'You could end up bleeding to death,' " he said. "It's
not like the polio vaccine," one version of which causes polio in rare cases instead of
preventing it.
In fact, the Ebola vaccine is made of laboratory-synthesized strands of DNA designed to preclude that possibility and other side effects.
With nearly atomic precision, researchers at Vical, a biotechnology company in San Diego, made the strands to mimic those found in the Ebola virus -- but with key components removed, including the part that triggers illness and the part that might allow the DNA to recombine with the DNA of some other virus to make a new and potentially disease-causing bug.
Volunteers will get three shots over three months. Blood tests will track their immune-system responses for a year.
The DNA enters subcutaneous skin cells, which use it to make Ebola proteins. Immune-system cells attack those proteins and then are primed forever to fight a real Ebola infection even more vigorously.
The long-term plan is to follow the DNA shot with a booster made of an adenovirus engineered to contain Ebola DNA. In a test of four monkeys given that one-two punch, all four were unfazed by an Ebola attack, while four monkeys given dummy shots all died, said virologist Anthony Sanchez of the Centers for Disease Control and Prevention, which helped develop the vaccine.
Because it would be unethical to expose humans to Ebola to test the vaccine's efficacy, scientists will simply compare their immune responses with those that proved effective in monkeys and other animals. Much larger human studies will eventually be conducted to provide final proof that the vaccine is
safe for large populations.
But first things first. To get 25 more volunteers, McCluskey is starting to focus her efforts on groups that might have a special appreciation for Ebola's African toll -- employees at the World Bank, for example, and Peace Corps people.
"When people read in the newspaper a few years from now that we're on a plane stopping an outbreak, they'll know they helped," McCluskey said.
By Rick Weiss
Washington Post Staff Writer
Wednesday, November 19, 2003; Page A01
Steve Rucker, a registered nurse at the National Institutes of Health, broke with his lunchtime routine yesterday, forgoing his usual visit to the cafeteria and opting instead to roll up his sleeve for a shot filled with the biological essence of Ebola -- one of the world's deadliest and goriest diseases.
Surrounded by a gaggle of doctors and scientists, Rucker stepped into medical history at 12:10 p.m., becoming the first person ever injected with an experimental vaccine designed to protect against Ebola, the disease that was highlighted in the real-life thriller "The Hot Zone" and that continues to take a bloody toll in Africa.
"I've had better lunches," Rucker quipped as the shot's 100 trillion strands of synthetic DNA began to make their way into the cells in his arm.
Rucker is a pioneer in a high-tech effort to beat Ebola. If the vaccine works in people as it has in monkeys, it could fell one of the world's most horrid infectious scourges.
Alas, health officials say, despite weeks of advertisements and other pleas, only two people have volunteered to be part of the effort.
"People freak out about Ebola," said Margaret McCluskey, the director of nursing at the NIH's vaccine research center, where the new vaccine -- the first for Ebola -- awaits 25 more people to participate in initial safety tests.
When the NIH started testing an experimental vaccine for AIDS, many people with friends or lovers affected by that disease stepped forward. When it was for smallpox -- a disease feared these days as a weapon of bioterrorism -- a mix of patriotism and self-interest drew even more volunteers.
This time, however, the telephones are eerily silent. Almost no one, it seems, wants to
get an Ebola shot. Indeed, the only volunteer so far other than Rucker is a landscaper
who works in McCluskey's Silver Spring neighborhood.
"I basically raked him in," she conceded.
It is not surprising that people would hesitate about getting injected with anything
labeled "Ebola." The disease is notoriously lethal, rapidly killing 50 percent to 90
percent of its victims. Just the thought makes people irrational.
Already, the landscaper has been asked by some clients whether he is going to be
bringing the disease to the neighborhood.
The irony, scientists and doctors lament, is that this first Ebola vaccine is probably the safest and most sophisticated vaccine ever made, without a single component coming from the virus itself.
Indeed, the product spray-blasted into Rucker's arm (no needle necessary) is by any standard a marvel of biotechnological engineering. It was designed to rally the immune system even more than a real Ebola infection would, without causing any symptoms of the disease itself.
"It's remarkably sophisticated technology," said Gary Nabel, the virologist who is leading the Ebola effort in a fast-track program that has catapulted his basic research from the lab bench to the clinic in just three years.
Inexplicably, the frequency of Ebola outbreaks in Africa has been increasing. But it is not just Africans who will benefit, said Anthony S. Fauci, chief of the National Institute of Allergy and Infectious Diseases, which oversees NIH's vaccine research center. Like the smallpox virus and the bacterium that causes anthrax -- for which vaccines, though imperfect, at least exist -- Ebola virus, too, is a potential bioterrorism agent.
"In its natural form it's not the best," Fauci said. "You need close contact for it to spread. . . . But an aerosolized form would be extremely treacherous. And from a psychological terror aspect, you don't need a lot of people bleeding to get enormous terror in the population." The virus causes clotting abnormalities and tears holes in blood vessels, causing victims to bleed to death from multiple sites, including eyes, mouth and nose.
A vaccine, Fauci said, might deter those who would think about using such a weapon
and would be "a big cause of comfort" for citizens, who would know that protection is
available.
Rucker, 36, said he got religion about the importance of vaccines while living in
medicine-deprived parts of South America.
"It sounds funny to say I'm excited about an Ebola vaccine, but this really is an
exciting trial," he said. "It's so rare in research that you get to help with something
that's so promising. And the pharmaceutical industry would never do this. There's no
profit in this."
He has looked at the animal safety data and studied the informed-consent document
that spells out the risks -- which are largely limited to soreness around the injection
site.
"There's nothing in there about 'You could end up bleeding to death,' " he said. "It's
not like the polio vaccine," one version of which causes polio in rare cases instead of
preventing it.
In fact, the Ebola vaccine is made of laboratory-synthesized strands of DNA designed to preclude that possibility and other side effects.
With nearly atomic precision, researchers at Vical, a biotechnology company in San Diego, made the strands to mimic those found in the Ebola virus -- but with key components removed, including the part that triggers illness and the part that might allow the DNA to recombine with the DNA of some other virus to make a new and potentially disease-causing bug.
Volunteers will get three shots over three months. Blood tests will track their immune-system responses for a year.
The DNA enters subcutaneous skin cells, which use it to make Ebola proteins. Immune-system cells attack those proteins and then are primed forever to fight a real Ebola infection even more vigorously.
The long-term plan is to follow the DNA shot with a booster made of an adenovirus engineered to contain Ebola DNA. In a test of four monkeys given that one-two punch, all four were unfazed by an Ebola attack, while four monkeys given dummy shots all died, said virologist Anthony Sanchez of the Centers for Disease Control and Prevention, which helped develop the vaccine.
Because it would be unethical to expose humans to Ebola to test the vaccine's efficacy, scientists will simply compare their immune responses with those that proved effective in monkeys and other animals. Much larger human studies will eventually be conducted to provide final proof that the vaccine is
safe for large populations.
But first things first. To get 25 more volunteers, McCluskey is starting to focus her efforts on groups that might have a special appreciation for Ebola's African toll -- employees at the World Bank, for example, and Peace Corps people.
"When people read in the newspaper a few years from now that we're on a plane stopping an outbreak, they'll know they helped," McCluskey said.