RT Journal Article SR Electronic T1 PEPtalk2: results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer JF Archives of Disease in Childhood JO Arch Dis Child FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health SP 25 OP 29 DO 10.1136/archdischild-2017-314212 VO 104 IS 1 A1 Jessica Bate A1 Stephen Baker A1 Judith Breuer A1 Julia C Chisholm A1 Juliet Gray A1 Sophie Hambleton A1 Aimee Houlton A1 Mark Jit A1 Stephen Lowis A1 Guy Makin A1 Catherine O’Sullivan A1 Soonie R Patel A1 Robert Phillips A1 Neil Ransinghe A1 Mary Elizabeth Ramsay A1 Roderick Skinner A1 Keith Wheatley A1 Paul T Heath YR 2019 UL http://adc.bmj.com/content/104/1/25.abstract AB 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.