ongitudinal follow-up of the new influenza A/H1N1 virus infection in vivo and in vitro in healthy volunteers

• Conditions: flu; influenza A (H1N1); 10047438

• Registration Number: NL-OMON34108
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Able and willing to give written informed consent
- Age 18-85 years
- PCR-confirmed new influenza A/H1N1 infection with symptoms present for less than 4 days.

Exclusion Criteria

- Therapy within the previous 60 days with:
* any experimental drug
* monoclonal antibodies
* growth factors
* other anti-cytokines
- Therapy within the previous 28 days with:
* anti-viral medication
* parenteral corticoid injections
* oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily
- Any clinically significant medical condition
- Mental condition rendering the patient unable to understand the nature, scope and
possible consequences of the study and/or evidence of an uncooperative attitude

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A. Frequency of in-vitro responding clones during follow-up of the new<br /><br>influenza<br /><br>A/H1N1 virus infection.<br /><br>B. Functional characterization of individual responding clones.<br /><br>C. Correlation of T-cell responses with antibody responses.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A. antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay to<br /><br>quantify the presence of specific antigens.</p><br>