Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model (NCT02525055) | Clinical Trial Compass
CompletedNot Applicable
Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model
46 participantsStarted 2014-01
Plain-language summary
The study will characterise Influenza A/Perth/16/2009(H3N2) virus in healthy participants using the viral challenge model. The study includes two cohorts.
Cohort 1: A randomised, double-blind study of 4 titres of Challenge Virus to determine the optimum titre.
Cohort 2: An open-label extension arm in which all participants will receive the 'optimum' titre as identified from Cohort 1.
Who can participate
Age range18 Years ā 64 Years
SexALL
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Inclusion Criteria:
* In good health with no history of major medical conditions.
* A total body weight ā„ 50 kg and a BMI of \>18.
* Acceptable forms of effective contraception.
* An informed consent document signed and dated by the subject and Investigator.
* Sero-suitable for Challenge Virus.
Exclusion Criteria:
* Subjects who have a significant history of any tobacco use at any time (ā„ total 10 pack year history, e.g. one pack a day for 10 years).
* Subjects who have been pregnant within six months prior to the study, or who have a positive pregnancy test at any point in the study.
* Any history or evidence of any clinically significant medical conditions (cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychotic, renal, and/or other major disease or malignancy).
* History or evidence of autoimmune disease or known immunodeficiency of any cause.
* Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology.
* Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test.
* Any significant abnormality altering the anatomy of the nose or nasopharynx.
* Any clinically significant history of epistaxis (nose bleeds).
* Any nasal or sinus surgery within six months of inoculation.
* Recurrent history of clinically significant autonomic dysfunction.
* Any abnormal laboratory test or ECG.
* Confirmeā¦