Primary; to determine vaccine- and non-vaccine serotype-specific pneumococcal carriage by culture. Secondary; to determine pneumococcal presence, density and multi-serotype carriage analysis using molecular methods, impact of PCV on presence of…
ID
Source
Brief title
Condition
- Other condition
- Bacterial infectious disorders
Synonym
Health condition
virale infectieziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total pneumococcal vaccine and non-vaccine serotypes
Secondary outcome
pneumococcal and meningococcal presence by culture, pneumococcal and
meningococcal density and multi-serotype carriage analysis using molecular
methods, presence of other respiratory non-pneumococcal bacteria and viruses,
antibiotic resistance of isolates, microbiome and salivary antibodies.
Background summary
Current study is part of our long-term surveillance intended to monitor changes
in serotype specific pneumococcal nasopharyngeal carriage since introduction of
pneumococcal vaccination in the NIP in vaccinated children and their
unvaccinated parents.
Streptococcus pneumoniae (pneumococcus) is the leading cause of invasive
pneumococcal disease (IPD) like meningitis, sepsis and bacteremic pneumonia as
well as of respiratory infections like community acquired pneumonia and otitis
media. The highest disease incidence is observed in children below two years of
age and in elderly > 65 years of age. Disease caused by Streptococcus
pneumoniae is preceded by asymptomatic nasopharyngeal acquisition and
colonization.
Neisseria meningitidis, the bacterium that causes meningococcal disease, is an
obligate commensal of humans, which transiently colonizes the mucosa of the
upper respiratory tract but only occasionally causing invasive meningococcal
disease (IMD), depending on the clonal type and low population immunity to the
particular strain. IMD is relatively rare (at present 100-150 cases/year in the
Netherlands) but with severe symptoms and with mortality up to 20%, the burden
of IMD remains high. Meningococci can be classified into 13 serogroups based on
the capsular polysaccharides chemistry and immunogenicity. Of these 13
serogroups, six are responsible for the vast majority of disease cases with
strains of serogroup B, W and Y dominating in IMD in the Netherlands. The
incidence is highest in children under 5 years of age followed by adolescents,
young adults and elderly of over 75 years of age. Although cases of IMD are
generally rare, the severity of disease and the occurrence of outbreaks
strongly support a role for prevention by vaccination. Disease onset is often
a-specific but, within hours IMD progresses towards meningitis, sepsis and/or
septic shock.
Vaccination with a 7-valent pneumococcal vaccine (Prevenar-7, PCV-7) was
introduced in the Dutch National Immunization Program (NIP) for children in
2006 and replaced in 2011, by a 10-valent vaccine (PCV-10). In response to the
recent increase in MenW IMD incidence, the Minister of Health decided to
replace the monovalent meningococcal conjugate vaccine against MenC by the
4-valent conjugate vaccine MenACWY vaccination in spring 2018. In addition,
MenACWY conjugate vaccination will be implemented at the age of 14-18 years in
September 2018. PCV-10 and possibly also MenACWY vaccine reduce the acquisition
and density of vaccine serotypes in the nasopharynx of vaccinated children and
subsequent reduces transmission to others leading to an indirect protection of
the community (herd effects) thus enhancing the public health effect and
cost-effectiveness of this approach. After PCV vaccination the vacant niche in
the nasopharynx of vaccinated children is immediately filled by non-vaccine
pneumococci and possibly other potential pathogens that may be involved in
respiratory or invasive disease. The impact of MenACWY vaccination on the
vacant niche is currently unknown. Pneumococcal and meningococcal carriage in
young children will be monitored in the OKIDOKI-5 study.
Study objective
Primary; to determine vaccine- and non-vaccine serotype-specific pneumococcal
carriage by culture.
Secondary; to determine pneumococcal presence, density and multi-serotype
carriage analysis using molecular methods, impact of PCV on presence of other
nasopharyngeal respiratory non-pneumococcal bacteria and viruses, meningococcal
carriage by culture and meningococcal carriage, density and co-carriage by
molecular methods and to compare results of culture and molecular methods,
antibiotic resistance of isolates, the impact of vaccination on the microbiome
and salivary antibodies.
Study design
Observational, cross-sectional surveillance study
Study burden and risks
The burden and risk of the transnasal and transoral nasopharyngeal swab and two
saliva samples is minimal. The nose swab may cause a minor self-limiting nose
bleeding (less than 1:3000 from own experience). No risk or burden is involved
in the transoral nasopharyngeal swab, saliva sample collection using a sponge
in the mouth and the questionnaire. Overall, the home visit will take 45
minutes. The children and parents themselves have no benefit in participating
in this study, but they are the only possible group that can participate for
comparison with five previous surveillance studies, MINOES, OKIDOKI-1,
OKIDOKI-2, OKIDOKI-3 and OKIDOKI-4. They are also the age group in which future
meningococcal studies can determine the direct impact of MenACWY vaccination on
carriage. The outcomes of this study are applicable to children in this age
group that have followed the vaccination program according the Dutch NIP.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
*The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health, fever >38.5°C in the last two days is not considered as normal health)
*The parents/legal guardians have to be willing and able to participate in the trial according to procedure
*The child is 24-months-old (± 8 weeks) or for older siblings; the child is between 24 month (-4 weeks) and <6 years of age)
*The child has been vaccinated according to the Dutch NIP (including MenC vaccination, not MenACWY vaccination)
*Presence of a signed informed consent (the parents/legal guardians have
given written informed consent after receiving oral and written information);Parents/legal guardians of 24-month-old children are included when the child fulfils the inclusion criteria
Exclusion criteria
For the children
*Previous vaccinations with PCV using a vaccine and schedule that differs from the Dutch NIP of that age group
*Previous vaccinations with MenACWY vaccine
*Medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21, schisis), known or suspected immunodeficiency disease or other medical conditions);A parent/legal guardian who meets any of the following criteria will be excluded from participation in this study:
*Medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions)
Design
Recruitment
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 |
|---|---|
| CCMO | NL65919.100.18 |
| OMON | NL-OMON28461 |