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Influenza trial.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21325
Enrollment
10
Registered
2010-08-02
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RA, reuma, Rheumatoid Arthritis

Interventions

We want to study otherwise healthy volunteers undergoing new influenza A/H1N1 infection. We will combine in-vitro stimulation assays and High Throughput Sequencing to identify, quantify and phenotype

Sponsors

Academisch Medisch Centrum, div Immunology and Rheumatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Able and willing to give written informed consent; 2. Age 18-85 years; 3. PCR-confirmed new influenza A/H1N1 infection with symptoms present for less than 4 days.

Exclusion criteria

Exclusion criteria: 1. Therapy within the previous 60 days with: A. Any experimental drug; B. Monoclonal antibodies; C. Growth factors; D. Other anti-cytokines. 2. Therapy within the previous 28 days with: A. Anti-viral medication; B. Parenteral corticoid injections; C. Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily. 3. Any clinically significant medical condition; 4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.

Design outcomes

Primary

MeasureTime frame
1. Frequency of in-vitro responding clones during follow-up of the new influenza A/H1N1 virus infection; 2. Functional characterization of individual responding clones; 3. Correlation of T-cell responses with antibody responses.

Secondary

MeasureTime frame
Antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay to quantify the presence of specific antigens.

Contacts

Public ContactA.N. Scholten

Meibergdreef 9, F4-105

a.n.scholten@amc.uva.nl+31 (0)20 5662337

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)