HVC study to qualify molecular biomarkers associated with flu
Research type
Research Study
Full title
A human viral challenge (HVC) study to qualify molecular biomarkers associated with influenza disease.
IRAS ID
221326
Contact name
Hannah Wright
Contact email
Sponsor organisation
hVIVO Services Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 3 months, 7 days
Research summary
This is an exploratory healthy volunteer Human Viral Challenge (HVC) study with a total of 122 volunteers challenged (inoculated) with the influenza A/Perth/16/2009 H3N2 virus. This study aims to utilize the power of the HVC model to qualify a range of influenza disease prognostic biomarkers from either prior hVIVO discoveries or by discoveries made as a direct outcome from the data obtained from the study. These hypothesized biomarkers within the influenza disease course can then be used to predict the outcome of a particular facet of the disease.
The study consists of three parts:
1) Screening: Serosuitable volunteers will be invited to attend a study-specific screening visit within 90 days prior to entry to quarantine where the volunteers will be asked to complete an informed consent form and undergo scheduled screening assessments to determine their eligibility.
2) Quarantine phase: Two days prior to the day of inoculation with influenza challenge virus, volunteers will be admitted to quarantine where their eligibility will be reassessed. If volunteers remains eligible they will receive the challenge virus on day 0. Volunteers will be discharged from the quarantine unit on day 8, or later based on their clinical condition and the Principal Investigators assessment (Protocol Section 7.3.3.1). Volunteers will undergo a range of clinical assessments and safety monitoring (exacerbations, adverse events and concomitant medications) for the entirety of their stay in quarantine.
3) Follow-up: The volunteers will attend a follow-up 7 (±1) days following discharge from quarantine (day ±15 follow-up visit). Their final scheduled follow-up will be held on day 28 (±3), post viral challenge. Their symptoms will be reassessed and a complete safety examination performed.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0013
Date of REC Opinion
6 Feb 2017
REC opinion
Further Information Favourable Opinion