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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34108

Enrollment

Registered

2010-06-21

Start date

2010-04-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

flu influenza A (H1N1)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
A. Frequency of in-vitro responding clones during follow-up of the new influenza A/H1N1 virus infection. B. Functional characterization of individual responding clones. C. Correlation of T-cell responses with antibody responses.	—

Secondary

Measure	Time frame
A. antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay to quantify the presence of specific antigens.	—

Countries

Netherlands

Outcome results