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Applying infection control concerns to gene therapy protocols currently raises more questions than answers. In a presentation emphasizing that point, Julie Gerberding, MD, MPH, director of the Centers for Disease Control and Prevention’s hospital infections program, raised a series of rhetorical infection control questions at a recent gene therapy conference in Lexington, KY.
Some of the questions may be answered in part by upcoming guidelines based on the conference discussions, but others will likely require additional research as the emerging science of gene therapy continues to unfold. In the interim, some of the key questions infection control professionals may want to ask regarding proposed gene therapy protocols include these, summarized as follows:
• Is the virus used for the gene therapy vector replication-competent?
• Is the virus pathogenic in its wild-type form?
• Is the vector itself expected to cause disease or symptoms in the recipient or contacts?
• If a recombinant virus is biologically possible, would one expect the recombinant to have an increase or decrease in pathogenicity?
• What is the capacity to detect the vector in a patient or the people with whom the patient has had contact?
• What are the clinical syndromes one would search for (i.e., viral replication or illness)?
• What laboratory diagnostic testing is available? Are tests on site? Can the tests used to monitor replication also be expected to detect recombination?
• Concerning the possible transmissibility of the vector, what are probable body substance sources? How would the virus be expected to move from one patient to another? How long would the source or recipient be considered at risk for infection and transmission? If needed, what treatment options are available?
• What needs to be done if a health care provider, lab technician, or household contact is exposed to infectious material that could pose a risk of infection or disease? What will be the system of recognizing and reporting exposures? How will exposures be managed, both in terms of detecting infection should it occur as well as any postexposure treatments that might be used?
• What are the appropriate isolation protocols during a period of time when one is not certain about the potential for replication of the virus, both in the health care setting and in the home care setting?