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Influenza trial.


- candidate number8295
- NTR NumberNTR2459
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2010
- Secondary IDs10/084 MEC AMC
- Public TitleInfluenza trial.
- Scientific TitleLongitudinal follow-up of the new influenza A/H1N1 virus infection in vivo and in vitro in healthy volunteers.
- ACRONYMInfluenza trial
- hypothesisGaining knowledge on human responses against the influenza virus will help us in treating influenza infections and lead to more effective vaccines. Additionally, it might also lead to identification of individuals that have a high risk of morbidity and even mortality during infection.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2010
- planned closingdate1-okt-2010
- Target number of participants10
- InterventionsWe 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 the clones that play a functional role in influenza infections and follow them over time.
- Primary outcome1. 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 outcomeAntibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay to quantify the presence of specific antigens.
- TimepointsDay 0-4, 7, 14, 28, 56, 84, 112 and 140.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.N. Scholten
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- PublicationsN/A
- Brief summaryCountry of recruitment: the Netherlands.
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 the clones that play a functional role in influenza infections and follow them over time.
- Main changes (audit trail)
- RECORD2-aug-2010 - 23-aug-2010


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