Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study

NCT05794412 | Completed

• 1 other identifier: 2022-01722
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms:

• Cough
• Fever
• Tired
• Sore throat
• Difficulty breathing
• Respiratory distress
• Headache
• Loss (or alteration) of smell
• Loss (or alteration) of sense of taste
• Myalgias
• Chills
• Subjective fever
• Pink sputum (or coughing up blood)
• Thoracic pain
• Runny nose
• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Irritated or watery eyes
• Rashes
• Other

Conditions

SARS-CoV-2 Infection; Influenza Viral Infections; Virus Shedding; Mucosal Immunity; RSV Infection

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infectious viral load

  up to 14 days post symptom onset

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

You may qualify if:

• In general good health, as determined by study investigators
• All participants must be living in the canton of Geneva or working/studying in the canton of Geneva and living in neighboring communities that are within one hour travelling distance by car.

You may not qualify if:

• Inability to provide written consent.
• Severely immunocompromised subjects as determined by the study investigator
• Treated with inhaled drugs by nasal route within the last month

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Geneva, Switzerland: collaborator
• ModernaTX, Inc.: collaborator

Study Sites (1)

Geneva University Hospital

Geneva, 1204, Switzerland

Location

MeSH Terms

Conditions

COVID-19; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Study Officials

• Benjamin Meyer, Dr.

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: January 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

CH (1)