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

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.

paediatric haematology, paediatric oncology, prophylaxis, varicella
0003-9888
25-29
Bate, Jessica
d74c58c7-1b77-425f-a1cf-5550a4281443
Baker, Stephen
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Breuer, Judith
f2762443-c570-4da1-af7c-56ee30b0bb78
Chisholm, Julia C.
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Gray, Juliet
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Hambleton, Sophie
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Houlton, Aimee
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Jit, Mark
c99d1e17-a445-4ac7-8b56-ba179ebf5190
Lowis, Stephen
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Makin, Guy
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O'Sullivan, Catherine
afcd948e-ff0e-4663-b5f7-403e8d4372e7
Patel, Soonie R.
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Phillips, Robert
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Ransinghe, Neil
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Ramsay, Mary Elizabeth
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Skinner, Roderick
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Wheatley, Keith
7593db84-279b-4f04-886d-ad214fa91b52
Heath, Paul T.
b9b6e0e4-6bd0-4c16-b9f6-607b00137fe4
Bate, Jessica
d74c58c7-1b77-425f-a1cf-5550a4281443
Baker, Stephen
3ec6dbf2-c0ca-4d86-965c-84d25240ab91
Breuer, Judith
f2762443-c570-4da1-af7c-56ee30b0bb78
Chisholm, Julia C.
4b8f5543-aea0-40f2-b45f-08c98407d415
Gray, Juliet
12d5e17c-97bb-4d6d-8fc4-3914b730ed42
Hambleton, Sophie
284eae35-615f-4eae-adde-0f0419893c1e
Houlton, Aimee
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Jit, Mark
c99d1e17-a445-4ac7-8b56-ba179ebf5190
Lowis, Stephen
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Makin, Guy
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O'Sullivan, Catherine
afcd948e-ff0e-4663-b5f7-403e8d4372e7
Patel, Soonie R.
07a40491-04dd-47f5-ba56-5531fb91ba20
Phillips, Robert
4a015af1-3dd9-4c99-8007-027b688f5ee8
Ransinghe, Neil
aa62b6d4-4165-44e5-9ac6-5a3f0375fd7b
Ramsay, Mary Elizabeth
8320d895-e9d3-4abc-862e-fe923a4ac69d
Skinner, Roderick
81c21751-bf0c-488d-ac36-a384c39f1af9
Wheatley, Keith
7593db84-279b-4f04-886d-ad214fa91b52
Heath, Paul T.
b9b6e0e4-6bd0-4c16-b9f6-607b00137fe4

Bate, Jessica, Baker, Stephen, Breuer, Judith, Chisholm, Julia C., Gray, Juliet, Hambleton, Sophie, Houlton, Aimee, Jit, Mark, Lowis, Stephen, Makin, Guy, O'Sullivan, Catherine, Patel, Soonie R., Phillips, Robert, Ransinghe, Neil, Ramsay, Mary Elizabeth, Skinner, Roderick, Wheatley, Keith and Heath, Paul T. (2019) PEPtalk2: Results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer. Archives of Disease in Childhood, 104, 25-29. (doi:10.1136/archdischild-2017-314212).

Record type: Article

Abstract

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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More information

Accepted/In Press date: 17 April 2018
e-pub ahead of print date: 5 May 2018
Published date: 2019
Keywords: paediatric haematology, paediatric oncology, prophylaxis, varicella

Identifiers

Local EPrints ID: 422976
URI: http://eprints.soton.ac.uk/id/eprint/422976
ISSN: 0003-9888
PURE UUID: 8694abdf-1852-4cbe-8a1a-c2b8a95cea69
ORCID for Juliet Gray: ORCID iD orcid.org/0000-0002-5652-4722

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Date deposited: 09 Aug 2018 16:30
Last modified: 16 Mar 2024 03:33

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Contributors

Author: Jessica Bate
Author: Stephen Baker
Author: Judith Breuer
Author: Julia C. Chisholm
Author: Juliet Gray ORCID iD
Author: Sophie Hambleton
Author: Aimee Houlton
Author: Mark Jit
Author: Stephen Lowis
Author: Guy Makin
Author: Catherine O'Sullivan
Author: Soonie R. Patel
Author: Robert Phillips
Author: Neil Ransinghe
Author: Mary Elizabeth Ramsay
Author: Roderick Skinner
Author: Keith Wheatley
Author: Paul T. Heath

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