Protocol for the Use of Vaccinia Virus in Research

Investigators must obtain written approval from the Office of Environmental Health and Radiation Safety (EHRS) to use vaccinia virus in research. The Penn policy on the use of vaccinia virus in research follows national guidelines issued by the Centers for Disease Control and Prevention (CDC). These guidelines were revised in June 2001. Accordingly, the approval protocol for the use of vaccinia virus in research was recently revised to reflect the changes in the CDC guidelines. Vice Provost for Research, Dr. Neal Nathanson, approved the protocol after review by the University's Institutional Biosafety Committee.

CDC recommends that all persons working with nonhighly attenuated strains of vaccinia virus be immunized, if medically eligible, before beginning work with virus. Principal investigators must offer all laboratory personnel who directly handle cultures or animals contaminated or infected with nonhighly attenuated vaccinia virus, recombinant vaccinia viruses derived from nonhighly attenuated vaccinia strains or other Orthopoxviruses that infect humans, the opportunity to receive counseling and small pox immunization from HUP's Occupational Medicine. Other healthcare workers (e.g., physicians and nurses) whose contact is limited to contaminated materials (e.g., dressings) but who adhere to appropriate infection control procedures are at a lower risk for inadvertent infection, however, vaccination can be offered to this group. Recombinant, highly attenuated poxvirus strains (MVA, NTVAC, ALVAC, and TROVAC) are unable to replicate or replicate poorly in mammalian host cells; therefore, they do not create productive infections. Vaccination is not recommended for workers who do not handle nonhighly attenuated virus cultures or materials or who do not work with animals contaminated or infected with these viruses. Both the principal investigator and the individual(s) offered immunization are required to sign the consent/declination form.

The vaccinia (smallpox) vaccine that had prior FDA approval is no longer available. The current vaccine is a new formulation that is not FDA approved. Before it can receive FDA approval, it must be evaluated for safety and efficacy. Therefore, it is being made available by the Centers for Disease Control and Prevention as part of a clinical trial. Personnel interested in obtaining the vaccine must become a participant in the clinical trial.

For a complete copy of Penn's vaccinia protocol, consult the EHRS web site, www.ehrs.upenn.edu/protocols/vaccinia.html, or call EHRS at (215) 898-4453.

--Harriet Izenberg, Institutional Biosafety Officer, EHRS

  Almanac, Vol. 49, No. 14, November 26, 2002