Exposure to Varicella by children who have cancer. MedDRA version: 17.1 Level: PT Classification code 10046980 Term: Varicella System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Human Varicella-Zoster Immunoglobulin
Product Code: VZIG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: human varicella-zoster immunoglobulin
Other descriptive name: VZ
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Registration: a) Under 16 years of age. b) EITHER diagnosed with cancer such that there is a standard expectation of immunocompromising therapy OR currently receiving immunocompromising treatment for cancer OR within 6 months (180 days) of having received immunocompromising treatment for cancer. c) No current or previous allogeneic or autologous haemopoietic stem cell transplantation / rescue. d) Negative VZV serostatus result at cancer diagnosis or negative VZV serostatus result within the last 3 months as assessed locally. e) Written informed consent to registration received from parent/legal representative and, where appropriate, written patient assent. For randomisation: a) Patient has previously been registered in the PEPtalk2 trial, having satisfied all registration requirements. b) Registration criterion (c) continues to apply. c) Immunocompromising treatment for cancer must have been initiated prior to VZV exposure. d) Patient is able to commence either VZIG no more than 10 days after experiencing VZV exposure, or aciclovir at 7 days after experiencing VZV exposure (see sections 5.1.2 and 5.1.3). e) No renal impairment. Renal impairment is expressed in terms of glomerular filtration rate (ml/min/1.73m2). Child over 1 year: Estimated glomerular filtration rate (ml/min/1.73m2) = 40 x height (cm) x serum creatinine (micromol/litre). Normal renal function: > or equal to 90ml/min/1.73m2. f) Written informed consent to randomisation received from parent/legal representative and, where appropriate, written patient assent. Important note regarding thrombocytopenia: platelets must be > 50 x 109/L to receive an intramuscular injection of VZIG. Therefore, if a child is randomised to receive VZIG and platelets are found to be =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion from Registration: a) 16 years of age or over. b) Current or previous allogeneic or autologous haemopoietic stem cell transplant/rescue. c) Positive VZV serostatus result as assessed locally within the last 3 months. Note: renal impairment and thrombocytopenia are not absolute contraindications for registration as they might resolve by the time a chickenpox exposure and screening for randomisation occur. Exclusion from randomisation: a) Positive VZV serostatus result at time of screening. b) Contraindication to either aciclovir or VZIG, including – (i) thrombocytopenia (platelets < 50 x 109/L) that has not been corrected by platelet transfusion; (ii) renal impairment (exclude any child with GFR below 90ml/min/1.73m2); (iii) any other contraindications deemed to be relevant by the local Investigator or the Sponsor’s Clinical Coordinator(s). c) Inability to start either VZIG within 10 days of VZV exposure, or aciclovir at 7 days after VZV exposure. d) More than one VZV exposure within the past 12 weeks. e) Inability to tolerate medications via oral or enteral route. f) Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this pilot trial is to establish the likely rate of patient recruitment in a projected full-scale Phase III trial and to gather data which will allow for an informed sample size calculation for the main trial. This will enable a full-scale trial to compare the efficacy, safety and acceptability of varicella zoster immunoglobulin (VZIG) and aciclovir as post-exposure prophylaxis (PEP) for chickenpox in children receiving treatment for cancer. This would address the urgent need for evidence on how best to prevent chickenpox in children receiving treatment for cancer who are exposed to the virus. The proposed definitive study will be a multi-centre randomised controlled trial to compare aciclovir with VZIG. ;Secondary Objective: The secondary objectives of the pilot study are • To create interest in and support for the study among paediatric oncologists • To identify the most important costs and health-related quality of life implications and define the data to be collected for the assessment of the cost-effectiveness in a subsequent Phase III trial.;Primary end point(s): The primary outcome measure will be the number of patients randomised within 12 months of the trial opening to recruitment. Considered in relation to the number of patients registered and the number of patients screened, this will allow an informed evaluation of the trial enrolment rate amongst eligible patients. Data will therefore be collected on patients screened for the study at each centre and the number of eligible patients at each centre who agree to registration and to randomisation. In addition to the rate of enrolment, the following guidelines will also inform the design of the main study: • compliance with allocated treatment; • adherence to study follow up; • acceptability of study procedures to patients and clinicians; • proportion of scheduled quality of life surveys completed; • proportion of patients for whom health care resource use and care | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To gauge the acceptability of randomisation and intervention with either VZIG or aciclovir to proposed participants and their families and to estimate likely attrition rates ? To describe any symptomatic varicella occurring in trial participants within 12 (+/-2) weeks of either study intervention (VZIG or aciclovir) ? To describe details of the VZV exposure occurring in trial participants ? To assess varicella seroconversion at 12 (+/-2) weeks after PEP administration ? To provide data on which to estimate the required sample size for the full-scale trial ? To measure standardised health outcomes in trial participants who receive PEP and in those who develop varicella ? To collect information about costs and benefits of either study intervention to inform the assessment of cost-effectiveness in a subsequent Phase III trial ? To gauge acceptability of randomisation and intervention to paediatric oncologists ? To create interest in and support for the study among the study among relevant stakeholders including patients, families and healthcare teams;Timepoint(s) of evaluation of this end point: The end of trial will be 5 months after last randomisation. This will allow sufficient time for the completion of protocol procedures, data collection and data input. Trial data will then be analysed within 6 months of the LVLS. | — |
Countries
United Kingdom
Contacts
Public ContactTrial Coordinator
University of Birmingham
Outcome results
None listed