Primary objective: * The main objective is to assess the effect of third dose of MMR (MMR-3) in young adults 18-25 years of age on the development and duration of mumps-specific serum virus neutralization (VN) and IgG antibody concentrations (…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* The mumps-specific VN antibody concentrations (against the vaccine and
currently circulating mumps virus strains) and IgG antibody concentrations
(including antibody avidity) measured in serum samples taken prior to and 10
days, 4 weeks, 1 year and 3 years following a third vaccine dose of MMR
Secondary outcome
* Frequency and intensity of the local and systemic adverse events
* Mumps-specific IgA and IgG (saliva) prior to, 4 weeks and 1 year following a
third vaccine dose of MMR
* The presence and frequency of mumps-specific memory and effector T- and
B-cells in peripheral blood following MMR-3, in a voluntary subset of the
participants (n=30) prior to, 4 weeks and 1 year following a third vaccine dose
of MMR
* Serum IgG response against measles and rubella (components of the MMR
vaccine) prior to, 10 days, 4 weeks, 1 year and 3 years following a third
vaccine dose of MMR
Background summary
In 1987, MMR vaccination was implemented in the national immunization program
of the Netherlands (NIP) by offering vaccinations to children at the age of 14
months and 9 years. Consequently, the annual mumps incidence decreased
dramatically, not only in the Netherlands, but also in other countries where
mumps vaccination was implemented. However, in the past two decades large mumps
outbreaks were reported in various countries despite routine MMR vaccination
mainly affecting young adults that have been vaccinated twice. Also in the
Netherlands, since 2004, several mumps outbreaks among vaccinated persons have
occurred, despite high vaccination coverage of 96% and 93%, respectively, for
the first and second MMR dose. The main explanations for the re-emergence of
mumps in vaccinated populations are waning of vaccine-induced immunity and
resurgence of specific wild type mumps virus strains (e.g. genotype G5),
possibly due to antigenic differences. Vaccinated young adults (18-25 years),
and in particular students, who have acquired immunity against mumps solely by
vaccination and not by previous wild-type mumps virus infection, appear to be
most prone for mumps infection. The fact that close social contact facilitates
virus transmission combined with import of mumps cases via student exchange
programmes from countries were mumps is still endemic further increases the
risk for this population. Mumps outbreak control so far has been restricted to
offering MMR vaccination to non- or incompletely vaccinated individuals. A
third dose of MMR could be an effective intervention to control outbreaks among
vaccinated persons, but sufficient evidence regarding immunogenicity and
effectiveness is currently lacking. For this purpose, the short- and long-term
mumps-specific humoral and cellular immunity induced following a third dose of
MMR vaccine will be investigated in young adults.
Study objective
Primary objective:
* The main objective is to assess the effect of third dose of MMR (MMR-3) in
young adults 18-25 years of age on the development and duration of
mumps-specific serum virus neutralization (VN) and IgG antibody concentrations
(including antibody avidity) between 10 days to 3 years following MMR-3.
Secondary objectives:
* To assess the local and systemic tolerance of MMR-3.
* To assess the short- and long-term (4 weeks and 1 year) mumps-specific IgA
and IgG levels (in saliva) following MMR-3
* To explore the presence and frequency of mumps-specific memory and effector
T- and B-cells in venous blood, 4 weeks and 1 year after MMR-3
* To assess IgG response (10 days, 4 weeks, 1 year and 3 years) against measles
and rubella following MMR-3.
Study design
An interventional, longitudinal, prospective study.
Intervention
All participants will receive an extra MMR vaccination (intramuscularly) at
visit 1.
Study burden and risks
Available data on a third dose of MMR vaccine in young adults does not suggest
any elevated frequency or unusual patterns of adverse events compared to the
first and second MMR immunizations given within the routine national
immunization program (RVP).
From all participants blood and saliva samples will be collected.
Blood collection is harmless but may be slightly painful and can cause a bruise
at the injection site.
Saliva sampling is easy and without adverse effects in the experience of the
research team.
The benefit for the subjects to participate in this study is that they might be
better protected against mumps and its complications, because of the additional
vaccination against mumps.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
Healthy young adult 18-25 years of age., Previously been immunized with two
doses of the MMR vaccine according to the Dutch NIP (MMR-1 at ~14 months and
MMR-2 at ~9 years).
Exclusion criteria
Medical conditions that will severely affect immunological responses to
vaccinations, such as, but not limited to, cancer or an immune disorder.,
Vaccination should be postponed during any illness with fever >38.5°C until the
fever has disappeared., Vaccination with any vaccine during the first two weeks
before and four weeks after MMR-3., An additional MMR vaccination during the
study., Coagulation disorder and/or anticoagulant medication. , Be or have been
under immunosuppressive medical treatment, like cytostatics, high-dose
corticosteroids, immune globulins, blood or plasma transfusions that might
interfere with the results of the study (within the previous 3 months)., Have
or previously had clinical symptoms of mumps virus infection., Have or
previously had cases of mumps disease within your Household., Had experienced a
previous severe adverse reaction to any vaccine. , Being pregnant; Furthermore,
pregnancy should be avoided for 1 month following vaccination. , Breast-feeding
women.
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001104-36-NL |
| CCMO | NL57282.094.16 |