To identify serological correlates of protection against clinical measles and measles virus infection in once vaccinated children.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Identification of serological (measles neutralizing antibodies and IgG)
correlates of protection against clinical measles and measles virus infection.
Secondary outcome
* To study a measles IgG correlate for protection in oral fluid;
* To describe measles compatible symptoms among once vaccinated individuals who
seroconvert to measles but do not meet the clinical case definition
(*attenuated measles*);
* To assess the attack rate of measles symptoms in the study population.
* To assess the degree of underdiagnosis, underreporting and the burden of
disease of measles in the study population.
Background summary
Measles is of global public health importance due to its high burden of
morbidity and mortality and its extreme infectiousness. A safe and effective
vaccine is available to prevent measles. To assess the prevalence of
immunological protection against measles, quantitative IgG antibody levels are
usually compared with a cut-off level indicating protection. The correlate for
protection used for this is, however, based on a very limited set of data. In
the Netherlands, a measles outbreak among individuals refusing vaccination is
ongoing. Based on observations during the previous outbreak in this group, a
substantial number of once vaccinated individuals in the vicinity of the
outbreak will also develop measles. This offers a unique opportunity to study
immunological correlates of protection against measles virus infection and
disease in vaccinated individuals. These correlates are necessary for assessing
the population*s immunity, and guide the development of new measles vaccination
strategies.
Study objective
To identify serological correlates of protection against clinical measles and
measles virus infection in once vaccinated children.
Study design
Observational study. In the study population we will administer a questionnaire
before and after the outbreak. This information will be used to assess the
attack rate of measles in this population. A subset of participants will be
invited for microbiological sampling prior to and after the outbreak. In this
subset we will correlate immunological findings with occurrence of measles and
measles virus infection.
Intervention
interventie
Study burden and risks
Parents of all participating children will be asked to twice fill in a short
questionnaire (before and after the outbreak). Parents of a subset of children
will be invited to twice attend a dedicated study clinic with their child. The
clinic will be located close to their residence or at the school of their child
or at home. They receive additional information about the study and are
requested to fill in an informed consent form. At the first visit to the clinic
(prior to the outbreak) a venous blood sample (4 ml) and an oral fluid sample
will be taken from the child. At the second visit (after the outbreak) a finger
stick blood sample (200 µl) and an oral fluid sample will be taken from the
child. Risks associated with these sampling methods are negligible. Filling in
the questionnaires will take about 10 minutes per questionnaire. Participants
who attend for microbiological sampling will receive a gift voucher (*VVV-bon*)
of ¤10 for each of the two visits to the clinic.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
Children aged 4 - 8 years
Exclusion criteria
Children twice vaccinated with MMR vaccination
Design
Recruitment
Medical products/devices used
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 | NL22617.041.08 |