I didn't understand before that they were doing their testing on people.

http://www.boston.com/dailyglobe2/310/nation/Smallpox_vaccine_tested+.shtml

Smallpox vaccine tested

Hope is to dilute, expand US supply

By Liz Kowalczyk, Globe Staff, 11/6/2001

OCHESTER, N.Y. - Hundreds of volunteers began receiving injections of smallpox vaccine yesterday, answering the call of researchers trying to determine whether the US can dilute and expand its store of 15 million doses of the treatment in case of a terrorist attack using the virus.

The vaccine, which is being administered in varying strengths, will make many volunteers feel as if they have flu symptoms, and, in extremely rare cases, could cause inflammation of the brain or even death. The vaccine, made from a virus related to smallpox, prompts the immune system to develop antibodies.

Despite the discomfort and risks, the four university centers conducting clinical trials report a stream of calls from Americans who are willing to take part in the study, either out of a sense of patriotism or because they fear a smallpox outbreak and want to be protected.

Even though the centers are on an accelerated schedule with little time for advertising, they've received calls from more than 1,500 interested Americans for 684 slots. The trial coordinator at the University of Rochester's Strong Memorial Hospital, one of the test sites, found 40 inquiries alone on her answering machine yesterday morning.

''This is a tremendous response like we've never had before,'' said Sharon Frey, the lead researcher at St. Louis University, another test site.

Shortly before 10 yesterday morning, Emily Stoufer was injected with smallpox vaccine at Strong Memorial, aware that she is likely to develop a fever and aching muscles over the next several days. She volunteered, she said, because since Sept. 11 she finds herself feeling more patriotic.

''I'm concerned that if someone uses smallpox in a terrorist attack that people ... be able to get the vaccine,'' said Stoufer, a 22-year-old flute student at Nazareth College in Rochester.

It's not just patriotism motivating volunteers, it's fear. Some want the vaccine so badly, they'll even skirt the rules to get it.

The National Institutes of Health, which is overseeing the trial, has limited enrollment to 18- to 32-year-olds, who are certain never to have been vaccinated for smallpox. Dianne O'Brien, the trial coordinator at Strong Memorial, received a call from the mother of 15- and 17-year-olds who wanted them vaccinated. When O'Brien said they were too young, the mother said she would bring them in anyway, believing researchers would not know the difference. O'Brien has spoken to four other people who got angry when they were disqualified.

As a result, Strong Memorial and the other sites are asking for photo identification from all volunteers.

US Health and Human Services Secretary Tommy Thompson vowed after Sept. 11 to have smallpox vaccine for every American stored away within a year and is negotiating with drug companies to produce 300 million doses.

Meanwhile, the trials are intended to see whether diluted vaccine is as effective as full strength. If it is, health officials say that it may be possible to stretch the stockpile of the vaccine from 15 million doses to 75 to 150 million doses.

Thanks to a worldwide vaccination campaign, the World Health Organization declared smallpox eradicated in 1978. It was considered one of public health's greatest victories, eliminating a highly contagious disease that killed at least 100 million people over five centuries. The United States stopped vaccinating newborns for the virus in 1972 and, except for military personnel and some researchers who handle the vaccine, Americans have not been vaccinated since. For many of those who were vaccinated years ago, immunity has likely worn off.

The smallpox virus is supposed to exist only in highly secure laboratories at the Centers for Disease Control in Atlanta and in Koltsovo, Russia. But American intelligence officials have long feared that Iraq or other countries have somehow gotten hold of a supply. Because of these fears and because smallpox is so contagious and so deadly - it kills one-third of its victims - the government has rated it second to anthrax as a possible bioterrorist threat.

The volunteers in the clinical trials are receiving one of three doses: regular strength, a one in five dilution, and a one in 10 dilution.

Dr. John Treanor, who is leading the study at Strong, said it will be easy to tell whether the different strengths work: Volunteers who develop immunity will get a round sore on their arm. Those who receive the weakest strength - the one in 10 dilution - may not develop any immunity at all.

Among those vaccinated in the 1960s, six to eight people per million experienced serious side effects including inflammation of the brain, infections of the flesh and muscle, and death.

The NIH ordered the study on Oct. 1 at Strong, St. Louis, the University of Maryland, and Baylor College of Medicine in Texas, and told them to make it their highest priority. All 684 volunteers are supposed to be vaccinated three weeks from yesterday, and results should start coming in early next month. To accommodate the NIH, Treanor canceled two other vaccine studies sponsored by drug companies, one for whooping cough and another for flu, scheduled this fall.

On the 4th floor of Strong Memorial in the Clinical Research Center, which is adorned with American flags on walls, doors, and hanging from ceilings, nurse practitioner Carrie Nolan prepared to vaccinate Jonah Marshall, a 25-year-old medical student.

Study coordinator O'Brien took a vial from an aqua picnic cooler. The vial is wrapped in aluminum foil so researchers cannot see which strength of the vaccine they're giving the volunteer, a way of preventing bias. Nolan rolled up the left sleeve of Marshall's olive sweater, swabbed his arm with alcohol and drew a circle with a marker. Because the virus grows best in the skin, the vaccine is not injected into the muscle, but is poked into the bottom layer of the skin with a two-inch needle that looks like a tiny pitchfork. Nolan poked her volunteer's arm 15 times as required by the study protocol until blood appeared under the skin.

''From what I hear we have a limited supply of the vaccine,'' said Marshall, who waited a half hour to make sure he didn't suffer a negative reaction. ''Patriotism is mostly why I'm doing it. It's also a cheap way to get the vaccine. That's a bonus.''

The study is time-consuming. Volunteers must come into the center eight times and keep a detailed diary of their symptoms for the first two weeks. People with poor immune systems cannot volunteer. And study coordinators turned away pregnant women or parents with babies at home. Those who've been vaccinated can ''shed'' virus through their bandages and that cast off virus could cause infection in tiny children.

Because they're handling the vaccine, the staff working on the study were given the option of being immunized. Eight of the 10 nurses and technicians at Strong Memorial opted for the vaccine. ''None of us felt sick,'' Nolan told Marshall. ''But it itched like the beegeebees.''

The nurses working on the trial said they feel a sense of pride, too, even though the emergency pace has meant working nights to screen and enroll enough volunteers. The pharmaceutical industry often ''wants it done yesterday'' so the companies can show results to stockholders, O'Brien said. This time the pressure ''feels a little more worthwhile.''

-- Anonymous, November 06, 2001