A Prospective Epidemiological Cohort Study Evaluating Occurrences of Influenza-like Illness.

NCT05184387 | Completed

• 1 other identifier: OVX-FLU-001
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This Prospective epidemiological cohort study is being conducted in order to generate epidemiological data in support of Osivax's clinical development of a broad spectrum influenza vaccine based upon the internal influenza nucleoprotein (NP) as a target for immune response.

Conditions

Influenza

Outcome Measures

Primary Outcomes (11)

• Proportion of overall subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire.

  Through study completion, an average of 8 months.

• Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.

  Through study completion, an average of 8 months.

• Proportion of subjects reporting Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.

  Through study completion, an average of 8 months.

• Severity scores of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.

  Through study completion, an average of 8 months.

• Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.

  Through study completion, an average of 8 months.

• Severity scores of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.

  Through study completion, an average of 8 months.

• Duration of overall Influenza-Like-Illness cases as per Flu-PRO® questionnaire.

  Through study completion, an average of 8 months.

• Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with laboratory-confirmed influenza.

  Through study completion, an average of 8 months.

• Duration of Influenza-Like-Illness cases as per Flu-PRO® questionnaire with non-laboratory-confirmed influenza.

  Through study completion, an average of 8 months.

• Anti-NP immunoglobulin G (IgG) titers by ELISA at each time point.

  Through study completion, an average of 8 months.

• Symptomatic and asymptomatic flu cases based on the abovementioned variables/parameters.

  Through study completion, an average of 8 months.

Study Arms (1)

Prospective epidemiological cohort

Urban and suburban population of healthy subjects aged 18-55 years, not vaccinated against influenza

Other: Blood samples

Interventions

Blood samples OTHER

Collection of blood samples and completion of an electronic Diary (eDiary)

Prospective epidemiological cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects, men and women aged 18 to 55 years.

You may qualify if:

• Written informed consent.
• Healthy male or female subjects, as determined by medical history and medical examination (as needed).
• Between the ages of 18 and 55 years, inclusive.
• Subject who has fully been vaccinated with licensed severe Acute Respiratory Syndrome SARS-CoV-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group.
• Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
• Ability and technical possibility for completing an electronic Diary (eDiary) and electronic Flu-PRO® questionnaire (ePRO).

You may not qualify if:

• Previous influenza vaccination within 6 months before the day of enrollment or planned to receive during the study duration.
• Any known or suspected immunodeficient conditions.
• Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
• Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) to the subject's knowledge.
• Administration of any investigational or non-registered drug or vaccine within 3 months prior to enrollment, or planned administration of any such product during the whole study period.
• History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of enrollment, or planned to receive such product during the whole study period.
• Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.
• Past (stopped less than 6 months before enrolment) or current history of alcohol or drug abuse, or current smoking habit above 10 cigarettes per day, or current vaping.
• Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (\>800μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (\>10 days) use of systemic non-steroidal antiinflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator.
• Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.

Sponsors & Collaborators

• Osivax: lead
• University Ghent: collaborator

Study Sites (1)

Centre for Vaccinology (CEVAC)

Ghent, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples (total volume approximately 10 mL of whole blood per visit) obtained at study entry (before onset of the influenza season) and 6 months after, upon completion of the influenza season, will serve as alternative method for case confirmation and detection of unrecognized or asymptomatic infections.

MeSH Terms

Conditions

Influenza, Human

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Isabel Leroux-Roels, MD, PhD

  Centre for Vaccinology (CEVAC), Ghent University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: January 11, 2022
• Study Start: December 1, 2021
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)