Observational study to investigate incidence and aetiology of viral respiratory infections in young adults who are sharing housing with other young adults during the peak 2021/22 common cold season in the Netherlands.
- Conditions
- common coldViral respiratory infections10047438
- Registration Number
- NL-OMON52306
- Lead Sponsor
- eyden Labs BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
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 (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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• The proportion of study participants developing symptomatic or asymptomatic<br /><br>virus specific respiratory infections as assessed by clinical symptoms,<br /><br>laboratory-based multiplex PCR testing (ePlex), and/or seroconversion<br /><br>• Virus-specific loads in the upper respiratory tract of asymptomatic and<br /><br>symptomatic participants</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Overall risk of infection for each respiratory virus defined as the<br /><br>proportion of susceptible adult household contacts of an index case who<br /><br>subsequently become infected.<br /><br>• The risk of infecting (transmission) an adult household contact relative to<br /><br>viral load for each respiratory virus<br /><br>• At baseline and during scheduled visits outside a symptomatic episode, the<br /><br>concentration and seroprevalence of: hemagglutination inhibition (HI) titres<br /><br>against influenza viruses, serum IgG against coronaviruses; saliva IgA against<br /><br>influenza and coronaviruses </p><br>