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

NCT ID: NCT05184387

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-07-12

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.

Detailed Description

The present 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective epidemiological cohort

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

Blood samples

Intervention Type: OTHER

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

Interventions

Blood samples

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Written informed consent.

2. Healthy male or female subjects, as determined by medical history and medical examination (as needed).

3. Between the ages of 18 and 55 years, inclusive.

4. 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.

5. Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.

6. Ability and technical possibility for completing an electronic Diary (eDiary) and electronic Flu-PRO® questionnaire (ePRO).

Exclusion Criteria

1. Previous influenza vaccination within 6 months before the day of enrollment or planned to receive during the study duration.

2. Any known or suspected immunodeficient conditions.

3. Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.

4. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) to the subject's knowledge.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for vaccinology (CEVAC), University of Ghent, Belgium

UNKNOWN

Sponsor Role: collaborator

Osivax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabel Leroux-Roels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Vaccinology (CEVAC), Ghent University Hospital

Locations

Centre for Vaccinology (CEVAC)

Ghent, , Belgium

Countries

Belgium

Other Identifiers

OVX-FLU-001

Identifier Type: -

Identifier Source: org_study_id