A pilot study to understand the transmission dynamics of RSV in households and potential reduction of viral transmission.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are the probability of introduction of RSV into the
household by type of household member and probability of transmission between
household members. To determine the probability of types of household members
to introduce RSV in the household, we will identify the index case of each
household RSV episode as the first household member to be infected. To
determine the probability of transmission between household members, we will
reconstruct the chain of transmission using RSV testing results, information
from the questionnaires and a chain binomial model. To capture all RSV
infections, household members will be asked to take saliva samples twice per
week of follow-up. The presence of RSV in samples will be ascertained by PCR.
Secondary outcome
1. The annual incidence of RSV infection in households with young children
2. The proportion of asymptomatic RSV cases among all RSV infections in adults
and children
3. The rate of secondary RSV infections within the same household
4. The duration of RSV positivity
5. The delay between the first positive sample of two generations of cases
6. The secondary attack rate in grandparents who visit the household on a
weekly base
Background summary
Respiratory syncytial virus (RSV) causes a large burden, especially in infants
and older adults. New preventive strategies have recently been approved by the
European Medicines Agency to protect infants against severe RSV disease. These
strategies aim to decrease the burden of RSV but are not expected to limit
transmission. However, live-attenuated RSV vaccines targeted at older children
are currently at various stages of clinical development. As having older
siblings has consistently been found to be associated with an increased risk of
RSV infections, it has been hypothesized that older children serve as
reservoirs for RSV transmission. If this is the case, childhood vaccines have a
high potential to decrease RSV transmission and provide indirect protection to
high-risk groups. Understanding the dynamics of RSV transmissions in households
is important to assess the potential public health interest of future RSV
childhood vaccines against RSV. This household transmission study aims to
follow families with infants during their first RSV season to understand the
RSV transmission dynamics in households and estimate the role of children in
introducing RSV in the household.
Study objective
A pilot study to understand the transmission dynamics of RSV in households and
potential reduction of viral transmission.
Study design
Monocenter prospective observational household study.
Study burden and risks
In households that agree to participate in the study, parents will be asked to
complete a questionnaire at inclusion. During the winter season, all
individuals living in the household will be asked to take a saliva sample and
to complete a short (online) questionnaire on respiratory symptoms twice a
week. Parents will be trained to take their own samples (by spitting into an
tube) and to sample their children (in young children by means of a pipet to
obtain sample from their mouth), if needed, with assistance from a member of
the study team. The advantage of using saliva samples instead of nasopharyngeal
samples is minimizing discomfort. Regular home visits will be scheduled to
assist with sample collection, bring new study materials, pick up samples and
monitor follow-up. There is minimal risk associated with this study. None of
the study procedures is associated with any risk of serious complications. All
the study data will be coded to safeguard participants' privacy.
There is no direct benefit for the subjects participating in this study.
However, the results will improve our understanding of RSV transmission in
households. This is important information to evaluate if vaccinating older
children is likely to decrease RSV transmission and provide indirect protection
to high-risk groups.
The expected impact of this pilot study is that it will generate solid
household transmission data in the Netherlands. In addition, this pilot study
will form the basis for a larger confirmatory study which will allow us to
understand the potential indirect beneficial impact of RSV vaccination of
children beyond the first year of life.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Be part of a household with at least 1 child <6 months and one child <4 years
of age at the start of the RSV season (1 October or earlier if the RSV season
starts earlier).
- Willing and able to give informed consent for themselves and their children.
- Willing to adhere to the study specific procedures.
- Be part of a household in which all other household members gave consent to
participate in the study.
Optional
Grandparents (age >60 years) will be included when visiting the household at
least once a week for at least 4 hours (pe regular babysitting while parents go
to work) during the whole study period.
Exclusion criteria
- Clinically significant primary or secondary immunodeficiency.
- Having a household member who does not participate or who intend to be away
from the household for >1 month during the study period.
- Not able to communicate in Dutch or English.
- Any medical condition for which it is foreseen that the household member will
be hospitalized >7 days during the study period.
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 | NL86960.041.24 |