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Current challenges in developing effective guidelines for investiga- tional agents include limited knowledge of influencing factors such as the in vivo pathogenic potential of engineered viruses, duration of viral shedding, infectivity, unpredictable control over replication competent viruses with concomitantly administeredimmunomodu- lators, and finally, the potential for regaining replication competence or wild-type reversion of engineeredoncolytic viral
agents.The prin- ciples articulated here are also applicable to other nonvirologic bio- logic antitumor therapies, such as Clostridium novyi and Listeria monocytogenes, with specific attention to individual patient risks and appropriate instiutional review board oversight. For FDA-approved agents, the infection control community must
recognize the emergence of viral immunotherapy in mainstream oncologiccareand itspositiveimpact on patient survival to develop standardized guidelines that can be broadly adopted to overcome implementation challenges across a variety of settings (eg, inpatient vs outpatient or treatment in the context of a clinical trial vs nontrial setting). Protocols established for these agents will guide institutional practices for use of oncolytic viral vectors currently in development. The approach of embedding the role of infection preventionists
within existing research regulatory structure (eg, IBC or IRB) enhances adherence to IC recommendations. Through our rigor- ous process of preapproval agent review, operational planning, and postapproval audit and feedback, we have been able to achieve responsible conduct of research and safe implementation of vari- ous oncolytic viral vector trials. Recent modifications to NIH over- sight of human recombinant gene therapy trials, including the transfer responsibility to institutional biosafety committees, further highlights the importance of infection control oversight of oncolytic viral vector trials.24,25
Financial support. This infection control research was supported by the MSKCC Core Grant (grant no. P30 CA008748).
Conflicts of interest. Dr Glickman is a consultant for Vedanta Biosciences. All other authors report no conflicts of interest relevant to this article.
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