Potential Ebola Vaccine Passes First Human Tests

Housecarl

On TB every waking moment
Potential Ebola vaccine passes first human tests

WASHINGTON (AP) -- The first vaccine designed to prevent infection with the lethal Ebola virus has passed initial safety tests in humans and has shown promising signs that it may protect people from contracting the disease, government scientists reported Friday.

Just 21 people received the experimental vaccine in the early stage testing. Much more research is necessary to prove whether the vaccine will prove successful, cautioned lead researcher Dr. Gary Nabel of the National Institutes of Health.

Still, the results are encouraging for U.S. scientists who worry not only that the horrific virus might be used as a terror weapon but note that natural outbreaks in Africa seem to be on the rise.

Ebola hemorrhagic fever kills within days by causing massive internal bleeding. There is no cure. Ebola is highly contagious, and up to 90 percent of people who catch it die.

The virus was identified in 1976, and scientists still don't know where it incubates between outbreaks. So far they have occurred only in Africa, apparently when people come into contact with infected apes or bushmeat, the meat of ape, which is eaten in many areas of Africa.

A vaccine would be useful not only to quell a bad outbreak, but as advance protection for doctors, nurses and animal-care workers.

Nabel and colleagues at the NIH's Vaccine Research Center developed a vaccine made of DNA strands that encode three Ebola proteins. They boosted that vaccine with a weakened cold-related virus, and the combination protected monkeys exposed to Ebola.

The first human testing looked just at the vaccine's DNA portion; the full combination will be tested later.

At a microbiology meeting in Washington on Friday, Nabel and colleagues reported seeing no worrisome side effects when comparing six people given dummy shots with 21 volunteers given increasing doses of the DNA vaccine.

Moreover, the vaccine recipients produced Ebola-specific antibodies, giving "us some confidence that the vaccine is having an effect on the immune system," Nabel said.

Once the complete vaccine has passed additional safety testing, the question is how to prove that it will protect people. NIH plans to test whether people have the same immune-system reactions to the vaccine as do monkeys that are protected by it.

Copyright 2006 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.

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Housecarl

On TB every waking moment
MSNBC.com

'The Challenge is to Stay Vigilant'
Can the nation deal with a bioterror attack? A top health official says that 'substantial' progress has been made since 2001—but more work lies ahead
WEB EXCLUSIVE
By Jennifer Barrett
Newsweek
Updated: 4:28 p.m. ET Feb. 6, 2004

Feb. 5 - In the fall of 2001, when two anthrax-laced letters were sent to Democratic Senators Tom Daschle and Patrick Leahy, the spores were airborne in the Hart Senate Office Building before officials could issue any warning to evacuate the building. Scores of panic-stricken Senate staffers were put on antibiotics for days after the letter was discovered to protect against possible infection. And the building itself was shut down for a three-month, $27-million cleaning.

No one died on Capitol Hill, but the anthrax attacks did end up killing five and infecting six more around the nation. After that scare, mail security was beefed up to prevent a repeat attack. But this week, a letter sent to Senate Majority Leader Bill Frist tested positive for ricin, a poison that can be made from castor beans, and the administration then disclosed that ricin had also been found in mail bound for the White House last November.

Lawmakers say they were much better prepared this time around to deal with what they’re calling a bioterror attack. The building was evacuated quickly, Senate workers were monitored for signs of exposure (though no one appears to have been infected), soldiers were deployed, and investigators immediately began tracing the letter in hopes of tracking down the sender. But hopes for a quick resolution were slim. Investigators still have yet to find the person responsible for the 2001 anthrax attacks.

The government says it has made progress in other areas though. Since the fall of 2001, the Bush administration has spent or budgeted about $12.9 billion to prepare and protect the nation from a bioterror attack, including $5.2 billion in the budget for the 2004 fiscal year. But the recent reports of ricin-laced letters raise new concerns about how much better prepared we are now for such an assault. NEWSWEEK’s Jennifer Barrett spoke with Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID), the principal institute among the National Institutes of Health that supports biodefense research, about the progress we’ve made—and the work that lies ahead. Excerpts:

NEWSWEEK: How much better prepared are we today to handle bioterror threats than we were during the anthrax attacks?
FAUCIAnthony Fauci: Comparatively speaking, we are enormously better off. But there is still a lot that needs to be done. What we had in place then was really minimal. Now we not only have things in place we didn’t before, but we have a strategic plan to get us to a greater and greater degree of defending ourselves against bioterror attacks. You can never protect completely against any kind of bioterror attack, but you can certainly make the country much more ready to respond in case there is an attack.

Just last week, President George W. Bush proposed an additional $2.5 billion for “Project BioShield,” an initiative to speed production of vaccines and other countermeasures in case of biological or other terrorist attacks.

If you look at the total federal bioterrorism budget, it went from [about] $305 million in 2001 to now [$3.9 billion requested this year.] The number of Health and Human Services staff assigned to bioterrorism increased from 212 in 2001, to 1,700 now. That’s just at the level of the Department of Health and Human Services. I’m not even talking about the other agencies that are playing a role in this. The resources in so many arenas have increased extraordinarily.

How has the budget increase affected your agency’s efforts to fight bioterrorism?
At the time of the anthrax attacks we knew we would get a considerable amount of money. We put together a strategic plan that we modify intermittently, depending upon the scientific opportunities and the needs. The plan involved building the research capacity—both intellectual and physical—and implementing and supplementing basic research endeavors that are always the cornerstone of the applied research. That is really where we need to go at the end of the day because the money has been given to us to develop countermeasures. To us, that means diagnostics, therapeutics, and vaccines.

Last September, your office released a report that said “tremendous progress” had been made in developing these countermeasures for bioterrorism. Can you give some specific examples?
This is an example of one of the most rapid implementations of a program, because of the degree of urgency to it, that we have ever seen in the arena of biomedical research. In the progress report, we described more than 50 major initiatives we have put forth since the funding began. By the end of the summer, early fall, what was just a plan is now a reality.

The regional centers for excellence for biodefense and emerging infectious diseases, for example, is a five-year, $350-million program that we awarded this fall…And in September we also awarded the two national biocontainment laboratories and the additional nine regional biocontainment laboratories. We are starting to build an infrastructure not only to do research but that can serve as facilities in case—God forbid—there is an attack.

What about vaccines?
We did those dilution studies that allowed us to take the relatively small supply of smallpox vaccine, 18 million doses, and show you can dilute it at least one to five, or maybe one to 10, which gave us a good deal of flexibility to have enough vaccine in case we needed it. That really solved the problem of a lack of vaccine. But one issue associated with the smallpox vaccine is the potential for toxicity. Because of that, we got involved rapidly in some contract arrangements to develop a second-generation smallpox vaccine. We already have it in phase one clinical trials and have pilot lots. Within a reasonable period of time, we’ll have a smallpox vaccine that is much less reactive, and therefore much more safe, than the current one. The same holds true for the next generation anthrax vaccine. The anthrax vaccine available now is indeed effective, but there is a lot of baggage associated with it. That’s because of everything from the bad press to the attitude that there is something about it that is quite toxic—and I’m not saying that’s the case, but that’s what the perception is. The second-generation anthrax vaccine is already being made, it is being tested in phase one clinical trials. That is pretty rapid progression on two major vaccines.

Any other vaccines in the works?
Probably even more exciting is the progress that has been made with the Ebola vaccine. A year or two ago, we demonstrated that you could protect nearly 100 percent of monkeys with a vaccine against certain components of Ebola. We’ve now made a major leap and have already started the first phase one safety trial of an Ebola vaccine in humans.

Just with those three vaccines alone, substantial progress has been made in the past couple of years. We’re also working on vaccines for tularemia and plague and for hemorrhagic viruses. We have challenges in antidotes against botulism. We obviously need to scale up the antibodies in case we get an attack of botulism toxin. But from the standpoint of looking back and asking what has happened with money allocated, I think it has been pretty substantial.

When would those three vaccines be available to the public?
All three are being tried in phase one safety trials with humans. It’ll probably be a couple years for the anthrax and the smallpox, and another year after that for the Ebola. But if an emergency occurs, and a vaccine is in a clinical trial, you can use it in a clinical trial arena without necessarily waiting for the additional years it takes for the licensure of the vaccine.

How big a threat does ricin pose compared to anthrax and other bioterror agents?
It’s something you need to pay attention to, though it’s certainly not as efficient a killer as anthrax, for example, which can spread widely even though it doesn’t spread from person to person. You could put anthrax in a form of aerosolization that can have a major impact if you expose large numbers of people to it. Then you have smallpox or Ebola that spreads person to person. Ricin is a chemical, a toxin. It doesn’t efficiently do the things that anthrax can do. It doesn’t aerosolize very well. It’s extremely lethal when you get exposed to enough concentration, but it’s not easy to have a widespread impact on a large number of people. But having said that, one reason to take it seriously is that it is very easy to make.

How serious is the threat of food or water contamination by ricin or similar poisons?
Well, when you’re talking about large reservoirs, usually when you dump something in it, it gets so diluted out by the hundreds of thousands of gallons that it is very difficult to contaminate such a water supply... If you sprinkle it in food, however, it’s not diluted. We all feel that the food supply is a vulnerable component and it is being obviously addressed by a number of agencies.

Do you think our food supply is adequately protected against such contamination?
I can’t comment because I don’t know. I don’t want to give reassurances on a subject that I am not an expert in.

I understand there is now no antidote for ricin. Is that something you are working on?
We are working on a vaccine for ricin, but for people who might be at high risk like those involved in a first-responder capability. What we need and we don’t have is some sort of antidote to block or absorb the ricin in someone who was very recently exposed to it. The difficulty with that is that it acts so quickly that you have got to get to the people really fast, if you want to have an impact. We’re trying to develop antidotes but it is not going to be easy.

Could your research be applied to natural disease outbreaks too?
One great advantage of putting the resources into a biodefense effort is that even if we never ever again have another bioterror attack, the amount of knowledge, experience, and insight into microbes, vaccines, therapeutics and how the immune system works, will absolutely have a positive value for the human species for an indefinite period of time.

What do you think present the biggest bioterror threats today?
When you think of something that is feasible and relatively easy to do, anthrax still stands way out there…On anybody’s top three, anthrax is always in there.

What would be the other two?
Botulism you’re always concerned about because of the lack of readily available antidotes and that it can contaminate food. And I guess you’d have to throw smallpox in there.

So ricin wouldn’t make the top three?
No, it wouldn’t. But be careful, I’m not downplaying it. The fact that I didn’t put it in the top three doesn’t mean I wouldn’t worry about it.

Looking ahead, what are the biggest challenges we face in preparing against bioterror threats?
The challenge is to keep the pressure on and to keep pushing. You don’t want to slack off just because you don’t have a bioterror attack for a year or two or three. The challenge is to stay vigilant and to continue to push for better countermeasures.
© 2005 Newsweek, Inc.

© 2006 MSNBC.com

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