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Table 2 Specific hygenic measures

From: Phase I/IIa study of intratumoral/intracerebral or intravenous/intracerebral administration of Parvovirus H-1 (ParvOryx) in patients with progressive primary or recurrent glioblastoma multiforme: ParvOryx01 protocol

• Information of staff involved in the medical care/nursing of trial subjects (e.g. physicians, nurses, cleaning staff, physiotherapist),

• Proposal of serological testing of medical staff for H-1PV prior to the beginning and at the end of the trial (in order to document potential seroconversion),

• Consideration of a subject as potentially viremic until:

â—‹ A seroconversion as proven by HIT or ELISA,

â—‹ In the absence of a seroconversion until proven lack of virus shedding in urine, saliva, and feces,

• While a subject is considered as potentially viremic:

â—‹ Isolate her/him in a single room with its own toilet,

â—‹ Use disposable gloves, protection gown and mask for handling of study medication and

materials contaminated with ParvOryx, e.g. infusion materials,

â—‹ Information of medical staff to use gloves, protection gown and mask when in physical contact with the patient,

â—‹ Information of medical staff and visitors to use mask only when strictly omitting body contact with the subject during his/her isolation phase. Alternatively, the subject can wear a mask when in the same room with medical staff and visitors,

â—‹ Information of hygiene staff to carry out a terminal disinfection after discharge of a subject from isolation,

○ In case of surface contamination the disinfection must be performed with Perform®, 3%

  1. ParvOryx01 is the first in man application of a GMP grade oncolytic parvovirus. The hygienic precautions listed above must be applied including isolation of patients in a single room as long as they are considered viremic. Virus shedding and seroconversion are tested daily to reduce duration of isolation to a minimum