No registrations found.
ID
Source
Brief title
Health condition
RA, reuma, Rheumatoid Arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay to quantify the presence of specific antigens.
Background summary
Country 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.
Study objective
Gaining 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.
Study design
Day 0-4, 7, 14, 28, 56, 84, 112 and 140.
Intervention
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.
A.N. Scholten
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662337
a.n.scholten@amc.uva.nl
A.N. Scholten
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662337
a.n.scholten@amc.uva.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2352 |
| NTR-old | NTR2459 |
| Other | MEC AMC : 10/084 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |