common cold Viral respiratory infections
Conditions
Interventions
None listed
Sponsors
Leyden Labs BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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: 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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
| Measure | Time frame |
|---|---|
| • 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 | — |
Countries
Netherlands
Outcome results
None listed