Condition category
Musculoskeletal Diseases
Date applied
02/02/2018
Date assigned
12/02/2018
Last edited
13/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chickenpox and herpes zoster are common infections that may be particularly severe in children with a suppressed immune system. It has been shown that vaccination with a live-virus chickenpox vaccine in children with cancer, HIV and after transplantation is very safe and effective. Most current guidelines, however, prevent children receiving intensive immunosuppressive treatment from live-virus vaccination due to concerns about safety and effectiveness. Current guidelines focus on the type of medication the patients are receiving. However, this is problematic since there is a growing number of antirheumatic medications and it is impossible to test the safety and effectiveness of vaccines in all of them. Therefore, in many countries, there is a large number of children with rheumatic diseases on immunosuppressive treatment who are at risk for severe chickenpox or herpes zoster. Children with rheumatic diseases often receive medications to suppress the immune system. It is suspected, however, that most children with rheumatic diseases on intensive immunosuppressive treatment may safely receive the chickenpox vaccine. A checklist has been developed to check the immune reaction of patients independent of the type of immunosuppressive treatment. The aim of this study is to find out whether children can be safely immunized after using this checklist.

Who can participate?
Children with rheumatic diseases on immunosuppressive treatment

What does the study involve?
Participants who demonstrate an adequate immune reaction on several simple tests receive the live-virus chickenpox vaccine, either once or twice (at least 6 weeks apart) based on whether the participant has previously received a dose of the vaccine. The safety of the vaccine is assessed by determining whether side effects have occurred, including flares of the rheumatic diseases, by sending out a questionnaire to the participants’ families within 12 weeks after vaccination. Regarding effectiveness, serum varicella zoster virus IgG (antibody) levels are measured within 4 to 12 weeks after vaccination. Participants are also interviewed after a longer period of time (3 years) to determine whether cases of chickenpox or herpes zoster, both causes by varicella zoster virus, have occurred.

What are the possible benefits and risks of participating?
The possible benefits include protection against varicella zoster virus infection, a potential cause for severe disease among immunosuppressed patients. The possible risks include exposure to two vaccinations which may cause brief injection site reactions and may be less effective compared to people who are not immunosuppressed. The study involves taking blood samples to test immune system function.

Where is the study run from?
Deutsches Zentrum für Kinder- und Jugendrheumatologie (Germany)

When is the study starting and how long is it expected to run for?
January 2012 to May 2015

Who is funding the study?
Verein Hilfe für das rheumakranke Kind (a non-profit foundation supporting pediatric rheumatology) (Germany)

Who is the main contact?
Dr Claas Hinze
claas.hinze@ukmuenster.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claas Hinze

ORCID ID

http://orcid.org/0000-0001-9247-4729

Contact details

University Hospital Münster
Department of Pediatric Rheumatology and Immunology
Albert-Schweitzer-Campus 1
Building W30
Münster
48149
Germany
+49 (0)2518341100
claas.hinze@ukmuenster.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Varicella-Zoster-Virus vaccination in immunosuppressed children with rheumatic diseases using a pre-vaccination checklist

Acronym

Study hypothesis

Children with rheumatic diseases on intensive immunosuppressive therapy may safely be immunized with the live-virus varicella vaccine after ensuring adequate immunologic reactivity via a checklist using several immunologic criteria.

Ethics approval

Institutional Board of Ethics in Medical Research of the Bavarian Chamber of Physicians, 19/11/2013, ref: 13072

Study design

Single-center open-label observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Immunosuppression and pediatric rheumatic disease

Intervention

During the trial safety of the varicella zoster virus vaccine will be assessed by determining whether adverse effects have occurred, including flares of the pediatric rheumatic diseases by sending out a questionnaire to the participants’ families within 12 weeks after vaccination. Regarding efficacy, serum varicella zoster virus IgG levels will be measured within 4 to 12 weeks after vaccination. Immunologic testing will also be carried out (blood count, differential count, total immune globulin levels, titers to inactivated vaccines, tuberculosis interferon gamma release assays, lymphocyte subpopulations). Furthermore, participants will be interviewed after a longer period of time (3 years) to determine whether cases of chickenpox or herpes zoster, both causes by varicella zoster virus, have occurred.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measure

Varicella zoster virus IgG level measured by commercial ELISA within 4 to 12 weeks after each vaccination

Secondary outcome measures

1. Safety, assessed using a questionnaire of possible adverse effects at 12 weeks after vaccination
2. Long-term clinical efficacy, assessed using an interview regarding the occurrence of chickenpox or herpes zoster after 3 years

Overall trial start date

01/01/2012

Overall trial end date

31/05/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Negative medical history for chickenpox and herpes zoster, corroborated by negative VZV-IgG level
2. Not more than 1 prior dose of the VZV vaccine
3. Diagnosis of an inflammatory pediatric rheumatic disease
4. Clinical inactive pediatric rheumatic disease
5. No change of IS for at least 3 months prior to the vaccination

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Acute febrile disease
2. Current clinical or laboratory evidence for lack of immunologic reactivity
3. Known hypersensitivity to constituents of the varicella vaccine
4. Measles, mumps, rubella (MMR) vaccination within 4 weeks prior to VZV vaccination
5. Treatment with immunosuppressive therapy other than those mentioned in the pre-vaccination checklist, i.e. i.v. glucocorticoid pulse therapy or a prednisone-equivalent dose of more than 2mg/kg/day or more than 20mg/day for > 2 weeks within less than 4 weeks prior to vaccination, cyclophosphamide pulse <6 months ago, rituximab without B-cell reconstitution, intravenous immune globulins (IVIG) <6 months ago (high-dose IVIG (2g/kg) <11 months), therapy with aspirin until 6 week post-vaccination or any blood products <3 months prior to vaccination

Recruitment start date

01/04/2012

Recruitment end date

31/05/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Deutsches Zentrum für Kinder- und Jugendrheumatologie
Gehfeldstr. 24
Garmisch-Partenkirchen
82467
Germany

Sponsor information

Organisation

German Center for Pediatric and Adolescent Rheumatology

Sponsor details

Gehfeldstr. 24
Garmisch-Partenkirchen
82467
Germany
+49 (0)8821 7010
info@rheuma-kinderklinik.de

Sponsor type

Hospital/treatment centre

Website

http://www.rheuma-kinderklinik.de

Funders

Funder type

Charity

Funder name

Verein Hilfe für das rheumakranke Kind (a non-profit foundation supporting pediatric rheumatology)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact open-access journal after registration.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

12/05/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes