Baker S

Bate J

Breuer J

Chisholm JC

Gray J

Hambleton S

Heath PT

Houlton A

Jit M

Lowis S

Makin G

O'Sullivan C

Patel SR

Phillips R

Ramsay ME

Ransinghe N

Skinner R

Wheatley K

\ua9 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. Objective: To determine the likely rate of patient randomisation and to facilitate sample size calculation for a full-scale phase III trial of varicella zoster immunoglobulin (VZIG) and aciclovir as postexposure prophylaxis against chickenpox in children with cancer. Design: Multicentre pilot randomised controlled trial of VZIG and oral aciclovir. Setting: England, UK. Patients: Children under 16 years of age with a diagnosis of cancer: currently or within 6 months of receiving cancer treatment and with negative varicella zoster virus (VZV) serostatus at diagnosis or within the last 3 months. Interventions: Study participants who have a significant VZV exposure were randomised to receive PEP in the form of VZIG or aciclovir after the exposure. Main outcome measures: Number of patients registered and randomised within 12 months of the trial opening to recruitment and incidence of breakthrough varicella. Results: The study opened in six sites over a 13-month period. 482 patients were screened for eligibility, 32 patients were registered and 3 patients were randomised following VZV exposure. All three were randomised to receive aciclovir and there were no cases of breakthrough varicella. Conclusions: Given the limited recruitment to the PEPtalk2 pilot, it is unlikely that the necessary sample size would be achievable using this strategy in a full-scale trial. The study identified factors that could be used to modify the design of a definitive trial but other options for defining the best means to protect such children against VZV should be explored. Trial registration number: ISRCTN48257441, EudraCT number: 2013-001332-22, sponsor: University of Birmingham

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PEPtalk2: Results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer

PEPtalk2: Results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer

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