Smallpox vaccine trials getting positive results

By JACK HURST, Staff Writer

Researchers at Vanderbilt University Medical Center and two other universities are pricking volunteers with dull needles and giving them weeping sores to try to ensure that a smallpox vaccination of emergency personnel won't infect the rest of the population.

Approximately 150 Middle Tennesseans ages 18 to 32 have been inoculated with varying amounts of long-frozen Aventis Pasteur smallpox vaccine. The aim is to find out whether the vaccine is effective in full, 20%-strength and 10%-strength dosages, and whether the people to whose shoulders it is applied can be contagious to friends and family.

So far, so good.

''With the volunteers, we haven't had any cases of spread to household contacts, spouses and so on,'' infectious diseases researcher Tom Talbot reported last week. ''That's because we are preaching meticulous hand hygiene.''

The trials -- in progress at Vanderbilt, the University of Iowa and the University of Cincinnati -- proceed under the looming specter of war with Iraq and federal-mandated preparations to safeguard Americans at home as soon as possible. Last week, under Bush Administration deadlines, Tennessee Health Department officials announced a plan to find 117 Tennessee emergency clinic sites and 20,000 volunteer workers to staff them by Feb. 28.

Asked if the rigidly controlled conditions of the Vanderbilt clinical trials could be reproduced in a mass vaccination, state epidemiologist Dr. Allen Craig said that was a good question. He added, however, that he recently saw U.S. data from before smallpox was declared eradicated in 1977, and these data showed just ''very small'' numbers of contaminated household contacts, ''maybe 5 million vaccine doses and less than 50 or 100'' people who contracted illness from them.

The vaccination process isn't pleasant. At Vanderbilt last week, a parade of trial participants trekked one after another into a hospital room to sit on a bed, roll up a sleeve and have Talbot examine the postage-stamp-sized, pus-filled vaccination site on each left shoulder.

The doctor dictated his observations to a graduate assistant who wrote them down, then changed the dressings on the grayish-yellow developing scabs. He covered them with a cellophane-clear, very sticky bandage, sometimes with a piece of gauze.

Craig said the Tennessee Health Department hopes to use this type of bandage in any mass vaccination effort it has to do, but adds that there may be a problem with that. The bandages cost 47 cents each, which would add up to an expensive total in an effort to inoculate significant numbers of Tennessee's 5.8 million residents.

Talbot asked the Vanderbilt trial participants to report any concerns.

Vanderbilt graduate student Chad O'Leary, 22, inquired whether it was normal to have sores developing on his back and to feel on his face the beginnings of a return of acne he hadn't had in years.

''I feel like I'm 14,'' he said.

Franklin veterinary technician Tricia Mewbourne and Nashville paralegal Suzy Matthews said that on post-vaccination days eight and nine, particularly, they felt so severely drained that they second-guessed signing up.

The vaccination is itchy, which Talbot knows. He said he got re-vaccinated just so he could understand what his patients were feeling.

Suzy Matthews, who said today was her ''day 11, visit five,'' noted that one of the real annoyances about the itching is that it can't be scratched.

Scratching would probably be the main cause of the spread of the virus from vaccinated people, if there's going to be any. Those who can't refrain from touching the bandages over the sores have an increased likelihood of getting contamination on their hands, from which they could spread it to others, especially at-risk people.

These include infants less than one year old, pregnant women and people with immune systems compromised by HIV or chemotherapy. Talbot said today's America has significantly larger numbers of at-risk people than it did when smallpox was considered still active in the world. He said that even with the new cellophane bandages, he wouldn't be surprised to find some contamination.

Some of the participants in the trials are first-responders. Paramedic supervisor Brian Bruce of Bedford County and Marshall County paramedic Chris Shadowens each said part of their motivation in participating was to go ahead and get a vaccination they may soon need anyway.

None of the participants interviewed voiced more than temporary regret at having done it. Metro Health Department epidemiologist Joe Schuchter, along with the others, said the trial's thorough screening out of high-risk people caused him to feel no personal concern about the vaccination risks. State officials say one person in a million can die from it, and 15 people in a million can have a side effect -- such as brain swelling or spread of the virus to other body parts -- that requires medical care.

Schuchter said he saw himself as part of an effort to ''allay public fear. ''I believe in science, and the best way to calm public anxiety is to acquire knowledge,'' he said.