Objective of the study is to evaluate efficacy of VZV vaccination in lung transplantation patients, intended to prevent morbidity by VZV infection. Efficacy of vaccination will be measured by means of determining cellular immunity to VZV. Cellular…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Viral infectious disorders
- Thoracic disorders (excl lung and pleura)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cellular immunity is chosen as the primary objective as this measure is known
to be more important than humoral immunity in the defence to VZV.
Main study endpoint will be changes in cellular immunity pre-vaccination, 2
weeks and 3 months after vaccination, and 3 months after lung transplantation.
Secondary outcome
As secondary objectives humoral immunity and control parameters will be
determined. Furthermore, herpes zoster incidence will be registered.
Background summary
Varicella-zoster virus (VZV) is known to cause varicella or *chickenpox* and
herpes zoster (shingles; *gordelroos*). In lung transplant recipients, a herpes
zoster incidence of 12.5-20.2% has been described, which is approximately 30
times higher than in the general population and 5 times higher than in those
>60 years of age. This incidence rate is higher than for solid organ transplant
recipients in general and may be particularly high in lung transplant
recipients because of the high doses of immunosuppressive medication they
receive.
A live attenuated vaccine to prevent herpes zoster, which is 14 times more
potent than the varicella vaccine intended for VZV-seronegative persons, has
been registered for use in healthy elderly in the United States of America.
This vaccine was shown to reduce the incidence of herpes zoster with 51% and of
post-herpetic neuralgia with 67% in people aged 60-70 years. No data are
available regarding use of this vaccine in lung transplantation patients.
In the 2016 listing criteria for heart transplantation by the International
Society for Heart Lung Transplantation (ISHLT), it is advised to consider
herpes zoster vaccination pre-transplantation.
In the UMCG, because of the high herpes zoster incidence, patients new on the
lung transplantation waiting-list will receive VZV vaccination as a part of
pre-transplantation work-up. This provides a unique opportunity for studying
immunological response to vaccination in this patient group.
Study objective
Objective of the study is to evaluate efficacy of VZV vaccination in lung
transplantation patients, intended to prevent morbidity by VZV infection.
Efficacy of vaccination will be measured by means of determining cellular
immunity to VZV. Cellular immunity is known to be more important than humoral
immunity in the defence to VZV. Furthermore, incidence of herpes zoster will be
recorded and compared between vaccinated and non-vaccinated patients.
Study design
Cohort study. On multiple time points before and after lung transplantation,
and before and after vaccination, blood will be drawn.
Study burden and risks
Participating in this study will not pose a risk to subjects, as participation
does not lead to alterations of standard patient care.
The participants will be asked to donate blood. Drawing blood is not considered
to be high-risk and in most cases can be combined with blood drawings for
routine diagnostic purposes. The study will provide highly interesting
information regarding infections in transplantation patients. Very little is
known on this topic at the moment.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• Provision of written informed consent
• >=18 years of age;(for the part evaluating vaccination)
• Intended administration of VZV vaccine
Exclusion criteria
• Pregnancy;(for the part evaluating vaccination)
• No administration of VZV vaccine due to any reason
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56805.042.16 |