Protecting Americans against a smallpox outbreak

In the event of a smallpox outbreak in the United States, how long would it take for a vaccine to start protecting Americans by stimulating an immune response? A new national study led by Saint Louis University School of Medicine will attempt to answer this question.

General routine vaccinations for smallpox were stopped in the United States in 1971, and the world was declared free of smallpox in 1980. But because of the recent concern about biowarfare and bioterrorism throughout the world, the U.S. government is making efforts to improve its ability to protect its citizens in the event of a bioterrorist attack involving the smallpox virus (Variola major virus).

This study at Saint Louis University will look at the ability of an investigational vaccine made by Bavarian Nordic to stimulate the immune system against smallpox.

“Vaccines prevent disease by giving the body a jump-start at recognizing the infecting virus or bacteria,” said Sharon Frey, M.D., the principal investigator for the study at Saint Louis University. “After successful vaccination, the body experiences a quicker fighting response to the infection, which lessens or completely avoids the symptoms of illness.”

Unlike some other diseases, getting vaccinated following exposure to smallpox could provide protective effects. For example, for the flu vaccine to work, people need to get vaccinated before being exposed to influenza. The currently licensed smallpox vaccine, however, provides benefits post-exposure, and may be useful in further preventing the spread of the disease.

“If there were a release of the smallpox virus, we would vaccinate people immediately after the release,” Frey said. “We'd move in and vaccinate people to prevent the spread.”

Frey said this research compares the ability of a new investigational smallpox vaccine called IMVAMUNE to produce a strong immune response against smallpox disease with another vaccine called Dryvax, the currently licensed vaccine. The new vaccine will be given either alone or in combination with Dryvax.

“Another purpose of the study is to see how quickly people can be protected against smallpox after a release of smallpox into the environment,” Frey said. Dryvax vaccine is the original Food and Drug Administration (FDA) licensed vaccine that was used to protect humans against smallpox disease. In this study, the Dryvax vaccine is being used as a research vaccine because its use in this study is different than the FDA approved current recommended use of this licensed vaccine.

The Dryvax vaccine is made from a live virus called vaccinia. The only people who presently receive this vaccine are people who work with viruses associated the risk of similar “pox” diseases; these are called by names like vaccinia, orthopox and monkeypox virus. (This group includes some government employees, some emergency workers military personnel and researchers).

This study is sponsored by the National Institutes of Health in cooperation with Bavarian Nordic A/S, the vaccine manufacturer. Up to 215 people will be enrolled in this study. Saint Louis University Center for Vaccine Development is one of seven centers conducting the study in the United States. Saint Louis University Center for Vaccine Development will enroll up to 50 participants.

The investigational vaccine is similar to licensed Dryvax but it is a highly attenuated (weakened) form of the virus. It is given under the skin using a needle and syringe similar to the way insulin is given and has less side effects than Dryvax.

Volunteers need to be healthy, at least 18 years of age and born after 1971. For more information about volunteering in the study, call the Saint Louis University Center for Vaccine Development at 314-977-6333 or visit http://vaccine.slu.edu on the World Wide Web.