Primary• To describe the incidence, aetiology and viral loads of (a)symptomatic viral respiratory infections in adults (18-40 years) who live in shared housing with at least 3 other adults during the peak common cold season in the…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The proportion of study participants developing symptomatic or asymptomatic
virus specific respiratory infections as assessed by clinical symptoms,
laboratory-based multiplex PCR testing (ePlex), and/or seroconversion
• Virus-specific loads in the upper respiratory tract of asymptomatic and
symptomatic participants
Secondary outcome
• Overall risk of infection for each respiratory virus defined as the
proportion of susceptible adult household contacts of an index case who
subsequently become infected.
• The risk of infecting (transmission) an adult household contact relative to
viral load for each respiratory virus
• At baseline and during scheduled visits outside a symptomatic episode, the
concentration and seroprevalence of: hemagglutination inhibition (HI) titres
against influenza viruses, serum IgG against coronaviruses; saliva IgA against
influenza and coronaviruses
Background summary
Respiratory viruses are a major cause of upper and lower respiratory tract
infections during the winter season in temperate regions. Severity of viral
respiratory illness varies widely, from asymptomatic to hospitalization and
death especially in high-risk groups, which poses a global health burden. Most
respiratory viruses, including, but not limited to, influenza, parainfluenza,
rhinovirus, coronavirus and respiratory syncytial virus (RSV), present with
common viral respiratory syndromes, such as common cold. This makes it
challenging to identify the causative agent of the disease based on symptoms
alone.
Study objective
Primary
• To describe the incidence, aetiology and viral loads of (a)symptomatic viral
respiratory infections in adults (18-40 years) who live in shared housing with
at least 3 other adults during the peak common cold season in the Netherlands
Secundary
• To evaluate transmission of respiratory viruses between adults within
households.
• To describe systemic and mucosal antibody responses against respiratory
viruses at a population level in healthy adults.
Study design
This is a descriptive observational study that is part of the clinical
development trajectory of intranasal prophylaxes and/or therapeutics against
respiratory viruses. A total of 104 adults (aged 18-40 years) living in shared
housing (minimum of 4 adults in 1 household) will be enrolled. The study will
consist of a screening visit and 7 follow-up visits at the Clinical Research
Unit (CRU) divided over a period of 12 weeks. Additional visits will be
scheduled if a participant or an individual in a participant*s household
becomes symptomatic and/or tests positive for a respiratory virus along the
course of the study. During the study, nasal and throat swabs will be collected
every 2 weeks and saliva and blood will be collected on the first visit, week 6
and week 12 for the study endpoints to identify seroconversion against
respiratory viruses during the season. Screening for eligibility will be
conducted at CHDR and blood samples will be collected at this time.
Participants will be asked to contact CHDR if there are changes at the time of
enrolment and at the end of the study from asymptomatic infected adults and
non-infected participating household members, as well as from symptomatic
infected adults including samples collected 2 weeks after onset of ARI/ILI in
their health status. Participants from 1 household should ideally start at the
same moment or within a period of one week of start of the first housemate.
When a study participant, or any other member of a household where study
participants live, shows signs of respiratory infection and/or tests positive
for a respiratory virus, the members of the household who are not part of the
study will be asked whether they are willing to participate in sample
collection for contact tracing of the primary case in that household only.
Additional visits for symptomatic cases with a corona- or an influenza virus
and their contacts will be scheduled at the time points when the probability of
virological confirmation of an infection from swabs is highest. An additional
informed consent form will be prepared for these situations. This will provide
the opportunity to analyze transmission of respiratory viruses more accurately.
Study burden and risks
This study does not involve any investigational drugs. The benefit obtained is
acquiring the knowledge on incidence and transmission events of respiratory
viruses in this adult population in order to evaluate the feasibility of
conducting clinical trials with prophylactic compounds in development in this
study population and inform the design of such trials. As no (medical)
intervention will be used in this study, the burden for the volunteer is
limited and only related to the study procedures. Only well-established methods
of sample collection will be applied, with a known and limited risk and no or
mild discomfort for the volunteer. In addition, all collections will be
performed according to standard operating procedures, by qualified medical
staff.
Keizersgracht 290 A
Amsterdam 1016 EW
NL
Keizersgracht 290 A
Amsterdam 1016 EW
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria (applicable to all participants in the study, including
housemates who only participate in contact visits)
1. Male or female, 18-40 years of age (inclusive) at screening;
2. Living in a shared household that include at least 4 adults within the age
range of 18-40 years old, of whom at least 2 will be participating in the study
3. Sharing common spaces in the house, such as kitchen, living room, bathroom,
etc. with household members mentioned above
4. Agreeing to sign the study informed consent form prior to any study-related
procedure indicating that he or she understands the purpose, procedures and
potential risks, and is willing to participate in the study;
5. Willing and able to complete the study procedures;
6. Has a primary care physician at the time of enrolment.
Exclusion criteria
Exclusion criteria (applicable to participants who will take part in the whole
study, but not to those who only take part in contact visits)
1. Received or plans to receive the 2021/22 seasonal flu vaccine during the
study period;
2. Received COVID-19 vaccines 14 days or less before screening or during the
study (COVID-19 vaccine boosters during the study are allowed);
3. Is not protected against SARS-CoV-2 infection during the whole study period.
In line with the National Institute for Public Health and Environment (RIVM in
Dutch) guidance, a person is considered to be protected against COVID-19 if one
or more of the following applies:
• it is more than 14 days since having received a second COVID-19 vaccination
with the AstraZeneca, Pfizer or Moderna vaccine;
• it is more than 28 days since having received one COVID-19 vaccination with
the Janssen vaccine;
• it is more than 14 days since having received one vaccination with any of the
COVID-19 vaccines used in the Netherlands, in combination with having had a
previous (PCR proven) COVID-19 infection;
• a (PCR proven) COVID-19 infection within the past 6 months provided the end
of these 6 months is after the ending of the study.
4. Plans to move homes during the study;
5. History of chronic rhinitis or (expected) active allergic rhinitis during
the envisioned study period;
6. Women in the third trimester of pregnancy during the study period (Jan-May
2022);
7. Immunocompromised or having received clinically significant
immunosuppressive medication or other immunomodulating agents (including
investigational drugs and not including vaccines except for the 2021/22
seasonal influenza vaccine) in the 3 weeks prior to the first study day and
during the study or 5 half-lives of the drug;
8. Clinically significant nasal abnormalities that might interfere with nasal
sampling procedures;
9. Loss or donation of blood over 500 mL within three months (males) or four
months (females) prior to screening, or donation of plasma within 14 days of
screening or intention to donate blood or blood products during the study;
10. Any known factor, condition, or disease that might interfere with
compliance, study conduct or interpretation of the results, as deemed by the
investigator.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL76302.058.21 |