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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02014870
Other study ID # H1N1_CS_01
Secondary ID 2013-002503-34
Status Completed
Phase Phase 1
First received December 5, 2013
Last updated December 12, 2013
Start date June 2013
Est. completion date October 2013

Study information

Verified date December 2013
Source Immune Targeting Systems Ltd
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial Summary

The primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies.

Illness parameters were collected by subject symptom scores as well as by physical examination. Virus parameters were measured by PCR and cell culture assay (performed by VisMederi srl).


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Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
1:1000 Live wild-type A/California/H1N1 2009
1:1000 dilution of neat virus
1:100 Live wild-type A/California/H1N1 2009
1:100 dilution of neat virus
1:10 Live wild-type A/California/H1N1 2009
1:10 dilution of neat virus

Locations

Country Name City State
Belgium SGS Life Sciences Antwerpen

Sponsors (1)

Lead Sponsor Collaborator
Immune Targeting Systems Ltd

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Frequency and severity of treatment-emergent adverse events as a measure of which dose of H1N1 challenge virus is safe for future intervention studies Day 1 - 29 Yes
Primary Infectivity Frequency and severity of influenza signs and symptoms experienced and incidence of laboratory confirmed infections, as a measure of which dose of H1N1 virus induces an appropriate level of illness/ infectivity for future intervention studies Day 1- 8 No
Secondary Kinetics Record influenza signs, symptoms, and viral load/shedding over time to assess kinetics of infection Day 1 -8 No
Secondary Immunology Assess immunological responses over the study period, including
humoral immune response to challenge virus;
cell mediated immune responses to virus proteins, including those specific for ITS' influenza A vaccine peptides;
Day 1 - 29 No
Secondary Biomarkers investigate gene expression to explore potential markers of influenza A infection that may be used in future intervention studies and, as such, determine mechanisms of vaccine efficacy Day 1 -29 No
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