The objective of this study is to gain insight into the occurence of mumps in a, presumed, highly immune student population, both clinical and subclinical mumps. Furthermore, there shall be an attempt to calculate the 'correlate for protection…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In the first analysis, the primary study parameter will be the measured mumps
titers in the paired serumsamples in the group that has claimed to have had a
clinical mumps infection. As a controle on the natural behaviour of MMR
antibody titers after several years, also measles and rubella titers will be
measured in the same multiplex ELISA at the RIVM.
In a second analysis, the occurence of clinical mumps (based on the
questionnaire) and subclinical mumps (based on a similar titerrise as in the
group with clinical mumps) is the primary study parameter. In this case, the
effect of the mumpstiters on the occurence of mumps will be investigated.
Secondary outcome
As secondary parameters the relation between the number of MMR vaccines (0, 1
of 2) will be related to the mumpstiters in the first serum sample.
Background summary
Since December 2009, the incidence of mumps has increased in the Netherlands.
The majority of cases are among students who have been vaccinated with at least
one dose of MMR vaccine.
Mumps vaccination is included in the Dutch National Immunisation Programme
(Rijksvaccinatieprogramma (RVP)). The outbreak among Dutch students might be
caused by waning immunity, in combination with specific social factors that are
characteristic for this group.
Study objective
The objective of this study is to gain insight into the occurence of mumps in
a, presumed, highly immune student population, both clinical and subclinical
mumps. Furthermore, there shall be an attempt to calculate the 'correlate for
protection' (the immunity level (antibodies or cellular immunity) of an
individual above which he/she is protected against infection).
Research questions:
1. What are the mumps antibody titers in a large group of 2e, 3e en 4e yr
medical students?
2. Is there a realtionship between mumps antibody titers and given vaccinations?
3. Is there a realtionship between mumps antibody titerknetics and the
occurence of clinical mumps?
4. What percentage of students has had a subclinical mumpsinfection (based on
mumpstiter kinetics)?
5. Which antibodytiter against mumps in the first bloodsample gives protection
against (clinical) mumps?
Study design
The study is a retrospective follow-up study conducted among medical students,
in which a questionnaire and paired serumsamples for mumps antibody testing are
obtained from participants.
The study populationd exists of medical students in Leiden, who are in their
second, third or fouth year of college. Besides a questionnaire and
serumsampling, these students are asked for their permission to analyse a
pre-exposure blood sample which is systematically stored as part of the HBV
vaccination programme at the start of their medicine study.
The questionnaire contains question regarding vaccination-status, some
riskfactors for mumps and questions on clinical signs of mumps.
Study burden and risks
The individual participant does not benefit from participating in this study.
He/she does benefit indirectly since the study aims to improve the National
Immunisation Programme, and it is only a small effort which is needed from the
participants.
There is negligible risk associated with the venapuncture for blood collection.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Medical students (2nd, 3rd, 4th year) from the LUMC.
Exclusion criteria
No exclusion.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL33696.058.10 |