1391. Infection Control for Research Studies Utilizing Oncolytic Viral and Bacterial Vectors
Session: Poster Abstract Session: HAI: Occupational Health
Friday, October 28, 2016
Room: Poster Hall

Background: Oncolytic viral and bacterial vectors are increasingly being studied as promising new treatments for cancer. In October 2015, the FDA approved the first genetically modified oncolytic viral therapy. However, infection control guidelines regarding the use of these agents are not well defined.

Methods: At our institution, all research protocols involving potentially contagious viral or bacterial vectors are reviewed by Infection Control. Approval by the Institutional Review Board and Institutional Biosafety Committee is contingent upon satisfactory achievement of all Infection Control requirements.

Results: Since 2013, we have reviewed 13 protocols utilizing 7 different vectors (Table 1). For all protocols, we required additional education of staff. For 12 (92.3%) protocols, we required additional infection control measures beyond those recommended in the study protocol (Table 2). No transmission events have occurred.

Conclusion: Study protocols regarding administration of oncolytic viral and bacterial vectors may not provide sufficient infection control guidance. Review by infection control experts provides additional safety.

Table 1

Agent

Description

Disease

Pexa-Vec

Modified vaccinia virus vector

Hepatocellular carcinoma

Talimogene Laherparpvec

Modified HSV-1, selective replication within tumors

Melanoma

AD-RTS-hIL-12

Replication incompetent adenovirus vector

Glioblastoma

CRS-207

Live, attenuated Listeria vector

Pancreatic adenocarcinoma

CG0070

Conditionally replicating adenovirus

Bladder carcinoma

CTL019

CD3+ T cells modified through lentiviral vector transduction

B-cell ALL,

Diffuse large B-cell lymphoma

KTE-C19

CD3+ T cells modified through retroviral vector transduction

B-precursor ALL, Mantle cell lymphoma

Table 2

Required Additions to Protocols

Number of protocols (%)

Education of staff

13 (100%)

Restriction of staff due to medical conditions (e.g. pregnancy, immunocompromised status)

6 (46.2%)

Patient isolation

5 (38.5%)

Preparation, storage, transport, or disposal of drug

9 (69.2%)

Environmental cleaning

7 (53.8%)

Minimize patient exposure to others in medical center (e.g. immediate rooming, staff escort)

5 (38.5%)

Patient card or bracelet with study information

5 (38.5%)

Jessica P. Ridgway, MD, MS, Department of Medicine, Section of Infectious Diseases and Global Health, University of Chicago, Chicago, IL, Allison H. Bartlett, MD, MS, Department of Pediatrics, Section of Infectious Diseases, The University of Chicago Medicine, Chicago, IL, Sylvia Garcia-Houchins, RN, MBA, CIC, FSHEA, University of Chicago Medicine, Chicago, IL, Rachel Marrs, MSN, RN, CIC, Infection Control Program, The University of Chicago Medicine, Chicago, IL and Emily Landon, MD, Infectious Diseases and Global Health, The University of Chicago Medicine, Chicago, IL

Disclosures:

J. P. Ridgway, None

A. H. Bartlett, None

S. Garcia-Houchins, None

R. Marrs, None

E. Landon, None

Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.