Viral respiratory infections in adults. Infections and Infestations
Conditions
Interventions
Participants will be followed for 12 weeks during the peak 2021/22 common cold season in the Netherlands. To assess asymptomatic carriage, throat and nose swabs will be collected every 2 weeks and ana
Sponsors
Leyden Laboratories B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 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; 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 COVID19 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) 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 |
|---|---|
| 1. The proportion of study participants developing symptomatic or asymptomatic virus-specific respiratory infections during the peak common cold season in the Netherlands as assessed by clinical symptoms, laboratory-based multiplex PCR testing (ePlex), and/or seroconversion: 1.1. Clinical symptoms assessed using the FluPRO Plus® questionnaire every time a subject experiences symptoms compatible with a respiratory infection. 1.2. Oro- and nasopharyngeal swabs for PCR testing collected every 2 weeks throughout the study period of 12 weeks, as well as, when a subject experiences symptoms compatible with a respiratory infection, or when a housemate has a symptomatic infection caused by any influenza or coronavirus. 1.3. Sera collected at screening (baseline), day 1, day 43 and day 85 will be assessed in the MesoScale Discovery (MSD) platform to evaluate seroconversion against respiratory viruses of interest during the 2021/22 winter season in the Netherlands 2. Virus-specific loads in the upper respiratory tract of asymptomatic and symptomatic participants: 2.1. Material from nasal and throat swabs will be used to quantify viral load by qPCR in samples that tested positive in ePlex | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline (screening) and during scheduled visits outside a symptomatic episode (day 1 and every 2 weeks until day 85), the concentration and seroprevalence of: serum IgG against influenza viruses, coronaviruses, and RSV; saliva IgA against influenza and coronaviruses | — |
Countries
Netherlands
Contacts
Public ContactLisanne Smidt
Outcome results
None listed