Development of a diagnostic algorithm that will diagnose measles cases and classify (potential) contagiousness of patients following measles infection.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is detection of measles viral RNA load in
oropharyngeal swabs and saliva.
Secondary outcome
Secondary study parameters are:
• Detection of measles infectious virus in pharyngeal swabs
• Level of local and systemic measles-virus specific antibody responses, in
relation to the primary virological endpoints.
• Proportion of contact of measles case that resulted in measles virus
transmission
• Severity of disease
• Determination of quantitative and qualitative measles-specific immunity in
vaccinated and unvaccinated measles cases.
Background summary
Measles outbreaks continue to occur, despite the availability of a safe and
effective vaccine. Also in the Netherlands occasionally measles cases and small
cluster occur as a result of import from other countries. Measles infection
also occur in cases that were previously vaccinated, which complicates
laboratory diagnosis and raises questions about the potential of virus
transmission to other susceptible hosts by previously vaccinated patients.
Although virus shedding is usually lower as compared to measles in unvaccinated
individuals, vaccinated cases have been identified in local measles outbreaks.
Furthermore, vaccination status cannot always be retrieved, which further
complicates the interpretation of laboratory results. Therefore, there is a
need for a diagnostic algorithm that is capable to detect and to classify
measles virus infections in cases irrespective of their immune or vaccination
status. A critical question in this context is what role these previously
vaccinated measles cases play in onward transmission of the virus and how
anti-measles immunity develops in comparison with unvaccinated measles cases.
Study objective
Development of a diagnostic algorithm that will diagnose measles cases and
classify (potential) contagiousness of patients following measles infection.
Study design
Longitudinal cohort study
Study burden and risks
From participants of this study will be visited once by a member of the
research team. During this visit, one pharyngeal swab, two saliva samples and
one fingerstick blood sample will be collected. In addition, the participant
will be asked to fill in a questionnaire and self-collect three additional
saliva samples on days, 2, 4 and 7 after the visit and to collect one
additional fingerstick blood sample 7 days after onset of exanthema. In
addition, participants from 9 years of age and older will be requested to
donate additional blood samples during a home visit at 4 weeks, 9, 18 and 36
months after onset of exanthema. For children from 9-16 years, dependent on
body weight, 10 to 56 mL venous blood (i.e. 1 to 7 heparin blood tubes) will be
collected, while for participants aged > 16 years, a maximum total of 60-70 mL
venous blood (i.e. eight heparin blood tubes) will be collected. This study can
only performed in measles cases, but risks of participation in this study are
negligible since only a limited number of samples will be collected with
minimal invasive procedures.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
• Older than 2 years of age (vaccination with the MMR vaccine is performed at
14 months of age)
• Laboratory confirmed measles case (by PCR and/or IgM serology) or suspected
measles case with an epidemiological link to a laboratory-confirmed measles case
• Recorded MMR vaccination status
• The (suspected) measles case (and parents/legal guardians) have to be willing
and able to participate in the trial according to procedure
• Presence of a signed informed consent (from the [suspected] measles case or
the parents/legal guardians)
• Additional inclusion criterium for the additional blood sample: at least 9
years of age and born after 1965.
Exclusion criteria
• Unknown MMR vaccination status
• Below 2 years of age
• Medical conditions that will severely affect immunological responses to
vaccinations or measles virus infections, known or suspected immunodeficiency
disease.
• Use of immunosuppressive medication
• For the additional blood sample: below 9 years of age or born before
1965.
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 | NL79243.041.21 |