{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T17:48:48Z","timestamp":1792000128256,"version":"4.4.0"},"reference-count":35,"publisher":"BMJ","issue":"1","funder":[{"DOI":"10.13039\/501100007602","name":"Programme Grants for Applied Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007602","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Arch Dis Child"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Multicentre pilot randomised controlled trial of VZIG and oral aciclovir.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>England, UK.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Study participants who have a significant VZV exposure were randomised to receive PEP in the form of VZIG or aciclovir after the exposure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>Number of patients registered and randomised within 12 months of the trial opening to recruitment and incidence of breakthrough varicella.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"ISRCTN48257441\" ext-link-type=\"isrctn\">ISRCTN48257441<\/jats:ext-link>, EudraCT number: 2013-001332-22, sponsor: University of Birmingham.<\/jats:p><\/jats:sec>","DOI":"10.1136\/archdischild-2017-314212","type":"journal-article","created":{"date-parts":[[2019,8,7]],"date-time":"2019-08-07T11:04:06Z","timestamp":1565175846000},"page":"25-29","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["PEPtalk2: results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer"],"prefix":"10.1136","volume":"104","clinical-trial-number":[{"clinical-trial-number":"isrctn48257441","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4933-9497","authenticated-orcid":false,"given":"Jessica","family":"Bate","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Baker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Breuer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia 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