Volunteers undergoing smallpox vaccine trials

By Paul Elias, The Associated Press
Tuesday July 09, 2002

SAN FRANCISCO — Doctors at an Oakland hospital jabbed decades-old smallpox vaccine into the arm of a volunteer Monday, the first of 50 people they hope to soon inoculate as part of government-sponsored human experiments nationwide. 

For three decades, 120 liters of the vaccine that’s now being tested sat nearly unnoticed in a walk-in freezer at a remote mountainside lab owned by Aventis Pasteur in Swiftwater, Pa. 

Officials with the Paris-based company thought the vaccine was so worthless, they were planning to destroy the stockpile of about 70 million doses until the terrorist attacks of Sept. 11. Aventis has since donated the vaccine to the federal government, which now must determine whether it’s still useable. 

About 330 volunteers will be inoculated with diluted doses over the next two weeks. Results are expected by mid-August, including those of the 50 volunteers at the Vaccine Research Center at Kaiser Permanente’s Oakland Medical Center. 

“In the past year, I think we’ve all become more aware of the possibility of a bio-terrorist attack in the United States,” said Steve Black, co-director of the center. “I hope we never need to use this vaccine again, but it’s important to make certain that if we do it will be available and it will work. 

“If we can show that this vaccine stock is still effective, it will go a long way toward making a dose of smallpox vaccine available for everyone in the U.S.,” Black said. 

The tests are part of a $12.6 million National Institutes of Health grant awarded last year to Vanderbilt University, which is overseeing the experiment and will enroll about 90 volunteers of its own. The University of Iowa and Baylor College of Medicine also are enrolling volunteers. 

Volunteers will receive a vaccine that either has been diluted to 20 percent or 10 percent of its current strength. It’s possible that the Aventis stockpile could provide up to 700 million doses if the most diluted treatment proves effective. That would add to the 15 million doses the federal government already has on hand. 

The United States stopped vaccinating the public in 1972 and smallpox was eradicated worldwide in 1977. But the disease can be used in germ warfare, renewing interest in mass vaccinations. 

Federal officials at the Centers for Disease Control and Prevention now are considering vaccinating as many as 500,000 health care workers and emergency personnel who would be first to see any smallpox cases. Because the vaccine carries significant risks — including death — officials do not want to resume mass vaccinations. 

All volunteers taking the Aventis vaccine are required to be healthy and between the ages of 18 and 32. The vaccine, which is a small dose of live smallpox, is dangerous for people with weakened immune-response systems. Scientists believe that if everyone were vaccinated, approximately one in every million persons inoculated would die. Thousands more likely would suffer side effects ranging from rashes to encephalitis. 

Two studies were released in March by The New England Journal of Medicine. They found that out of the 700 previously unvaccinated young adults who received some of the 15 million doses of the government vaccine, one-third had pain bad enough to miss school, work or other activities after being inoculated. While no one in the study fell seriously ill, some experienced fever, headache, nausea, muscle aches, lesions and swelling.