OKIDOKI-6: Research on carriage of pneumococcal bacteria and other bacteria and viruses in children and their parents
| ISRCTN | ISRCTN31549735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31549735 |
| Secondary identifying numbers | IIV-563 |
- Submission date
- 08/11/2022
- Registration date
- 16/02/2023
- Last edited
- 04/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and aims
In this research we monitor how many pneumococcal bacteria, other bacteria and viruses occur in the nose and throat.
Using the information on the different subtypes of the pneumococcal bacteria we can asses how well the currently used vaccine works. We can determine if a pneumococcal vaccine is needed that protects against more subtypes of the pneumococcal bacteria. We will also determine if the carriage of other bacteria and viruses is different than before SARS-CoV-2 occurred.
The current study is part of our continuous surveillance intended to monitor changes in serotype specific pneumococcal carriage in vaccinated children and their unvaccinated parents to establish effectiveness of the national pneumococcal vaccination program in the Netherlands. Since 2009 five pneumococcal carriage surveillance studies have been performed to establish the possible change in serotypes, and the suitableness of the vaccines. The effect of SARS-CoV-2 transmission prevention measures, that have been implemented since March 2020 on carriage of respiratory pathogens will also be determined. These non-pharmaceutical interventions led to rapid reductions in transmission not only of SARS-CoV-2 but also of other respiratory viruses such as influenza and respiratory syncytial virus.
Who can participate?
24-month-old children that have been vaccinated according to the NIP and one of the parents/legal guardians of each child.
What does the study involve?
The study involves a single home visit where a trained team member takes two saliva samples, an oropharyngeal swab and a nasopharyngeal swab of both the child and the parent. Also a questionnaire is used to record demographic and lifestyle data and relevant medical history information with respect to acquisition of pneumococcal carriage.
What are the possible benefits and risks of participating?
The children and parents themselves have no direct benefit in participating in this study. However, they may indirectly profit from societal changes in disease-incidence if the national immunization program will change. Furthermore, they are the only possible group that can participate for comparison with six previous surveillance studies, MINOES, OKIDOKI-1 to -5. The outcomes of this study are applicable to children in this age group that have followed the vaccination program according to the Dutch NIP. The risks are minimal, a minor self-limiting nose bleeding (less than 1:3000 from own experience).
Where is the study run from?
The Spaarne Hospital in Hoofddorp, the Netherlands.
When is the study starting and how long is it expected to run for?
January 2022 to February 2023
Who is funding the study?
The study is designed and coordinated by the RIVM (National Institute for Public Health and the Environment). The funding comes from the Ministry of Health, Welfare and Sport (the Netherlands)
Who is the main contact?
Alienke Wijmenga-Monsuur, OKIDOKI-6@rivm.nl
Contact information
Principal Investigator
PO Box 770
Hoofddorp
2130 AT
Netherlands
 ORCID ID |
0000-0002-5942-8082 |
|---|---|
| Phone | +31 232241665 |
| okidoki6@spaarnegasthuis.nl |
Scientific
PO Box 1
Bilthoven
3720 BA
Netherlands
| ORCID ID |
0000-0001-5663-860X |
|---|---|
| Phone | +31 886894154 |
| okidoki-6@rivm.nl |
Study information
| Study design | Observational cross-sectional surveillance study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | 42732 PIS_V4_01Sep2022.pdf |
| Scientific title | Cross-sectional surveillance study on pneumococcal carriage to establish a baseline before putative introduction of more-valent pneumococcal conjugate vaccine and to assess the impact of 2 years of SARS-CoV-2 containment measures on immunity and carriage of S. pneumonia and other microbes. |
| Study acronym | OKIDOKI-6 |
| Study objectives | The current study is part of our continuous surveillance intended to monitor changes in serotype specific pneumococcal nasopharyngeal carriage in vaccinated children and their unvaccinated parents to establish effectiveness of our national pneumococcal vaccination program. In this study bacterial colonization of commensals like S. pneumoniae, S. aureus, H. influenzae, HSTR as well as the presence of a panel of respiratory viruses will be determined in nasopharyngeal and oropharyngeal swabs. The panel of bacteria and viruses, with the addition of SARS-CoV-2, will be the same as in the five previous carriage studies. Potential changes in local and systemic immune status will be evaluated by measuring mucosal antibodies against these microbiota locally and compare these to levels measured in earlier OKIDOKI-3 to -5 studies. |
| Ethics approval(s) | The Centre for Clinical Expertise at the RIVM assessed the above-mentioned research proposal. They verified whether the work complies with the specific conditions as stated in the law for medical research involving human subjects (WMO). They are of the opinion that the research does not fulfill one or both of these conditions and therefore conclude it is exempted for further approval by the ethical research committee. |
| Health condition(s) or problem(s) studied | Pneumococcal carriage in children and their parents |
| Intervention | The study is an observational, cross-sectional surveillance study, in 24-month-old children that have been vaccinated according to the National Immunization Program, and one of the parents/legal guardians of each child. In total, 330 24-month-old children and 330 parents/legal guardians of the children will participate. The study involves only a single home visit during which demographic and lifestyle data and relevant medical history information with respect to acquisition of pneumococcal carriage will be collected through an interview of the parents/legal guardians. Thereafter, a trained member of the research team will collect two saliva samples, an oropharyngeal swab and a nasopharyngeal swab from the children and one of the parents/legal guardians of each child. Tests will be done for presence and sub types of pneumococcal bacteria and other bacteria. The following micro-organisms can be screened by PCR, MPLA or conventional bacterial culture: S. aureus, H. influenzae, Mycoplasma pneumoniae, and Bordetella pertussis, human influenza virus A and B, human parainfluenza virus, human respiratory syncytial virus (RSV) A and B, adenovirus, coronavirus, human metapneumovirus (hMPV), human rhinovirus and bocavirus |
| Intervention type | Other |
| Primary outcome measure | Pneumococcal (multi-) serotype carriage is measured in naso- (oro) pharyngeal swabs at a single time point. |
| Secondary outcome measures | At a single time point: 1. Respiratory viral and non-pneumococcal bacterial carriage is measured in naso- (oro) pharyngeal swabs 2. Antibiotic (non-) susceptibility of pathogens is measured in naso- (oro) pharyngeal swabs 3. (Functional) antibody levels against respiratory bacterial and viral pathogens is measured in saliva 4. Demographic, lifestyle and medical data influencing bacterial colonization are collected by verbal questions |
| Overall study start date | 01/01/2022 |
| Completion date | 20/02/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 660 |
| Key inclusion criteria | 1. 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) 2. The parents/legal guardians have to be willing and able to participate in the trial according to procedure 3. The child is 24-months-old (± 4 weeks) 4. The child has been vaccinated according to the Dutch NIP 5. Presence of a signed informed consent (the parents/legal guardians have given written informed consent after receiving oral and written information) 6. Parents/legal guardians of 24-month-old children are included when the child fulfils the inclusion criteria and sign their own informed consent |
| Key exclusion criteria | A potential participating child who meets any of the following criteria will be excluded from participation in this study: 1. Previous vaccinations with PCV using a vaccine and schedule that differs from the Dutch NIP of that age group 2. 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) A parent/legal guardian who meets any of the following criteria will be excluded from participation in this study: 3. 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) |
| Date of first enrolment | 26/09/2022 |
| Date of final enrolment | 20/02/2023 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hoofddorp
2130 AT
Netherlands
Sponsor information
Research organisation
PO Box 1
Bilthoven
3720 BA
Netherlands
| Phone | +31 886894154 |
|---|---|
| mensgebonden-onderzoek@rivm.nl | |
| Website | http://www.rivm.nl/en/ |
"ROR" |
https://ror.org/01cesdt21 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Dutch Ministry of Health, Welfare and Sport, VWS
- Location
- Netherlands
Results and Publications
| Intention to publish date | 20/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 4 | 01/09/2022 | 11/11/2022 | No | Yes |
Additional files
Editorial Notes
04/03/2024: The intention to publish date was changed from 20/02/2024 to 20/02/2025.
17/04/2023: The following changes have been made:
1. The recruitment end date has been changed from 01/04/2023 to 20/02/2023.
2. The overall trial end date has been changed from 01/04/2023 to 20/02/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 01/04/2024 to 20/02/2024.
24/11/2022: Trial's existence confirmed by ACLU (review board of the Spaarne Gasthuis).
