Biomarkers Predicting Infectivity in an Experimental Human Influenza Model

NCT03207152 | Unknown Phase 1 FDA Drug

• 1 other identifier: Pro00082500
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the hypothesis that gene transcriptional changes occur within 24 hours of virus exposure in the blood and nasal mucosa, and to identify early biomarker signatures that are predictive of higher viral shedding at the peak of disease

Conditions

Influenza A

Outcome Measures

Primary Outcomes (1)

• Viral load

  Nasal wash viral load by quantitative polymerase chain reaction (qPCR)

  28 days

Secondary Outcomes (4)

• Symptoms

  28 days

• Differentially expressed genes in blood

  9 months

• Differentially expressed genes in nasal curettage

  9 months

• Metabolomics in serum

  9 months

Study Arms (1)

Influenza A/California/04/2009

EXPERIMENTAL

Participants will be inoculated with Influenza A/California/04/09 3.5x10(4) tissue culture infective dose 50% (TCID50) in 1 mL in Dulbecco's phosphate buffered saline (DPBS) delivered by intranasal drops. They will then be monitored as in-patients for 10 days with daily clinical assessment and blood and respiratory tract sampling. Following discharge, they will be followed up for up to 6 months post-inoculation.

Biological: Influenza A/California/04/09

Interventions

Influenza A/California/04/09 BIOLOGICAL

Good Manufacturing Practices-certified Influenza A/California/04/09 3.5x10(4) TCID50 in 1 mL in DPBS delivered by intranasal drops

Influenza A/California/04/2009

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy persons aged 18 to 55 years, able to give informed consent

You may not qualify if:

• Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood
• Inhaled bronchodilator or steroid use within the last 12 months
• Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 6 months
• Acute upper respiratory infection or sinusitis in the past 6 weeks
• Smoking in the past 6 months OR \>5 pack-year lifetime history
• Subjects with allergic symptoms present at baseline
• Clinically relevant abnormality on chest X-ray
• Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (\>65 years), immunosuppressed persons, or those with chronic respiratory disease
• Subjects with known or suspected immune deficiency
• Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
• Known immunoglobulin A deficiency, immotile cilia syndrome, or Kartagener's syndrome
• History of frequent nose bleeds
• Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
• Pregnant or breastfeeding women
• Positive urine drug screen

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator
• Imperial College of London: collaborator

Study Sites (1)

Imperial College London

London, W12 0NN, United Kingdom

Location

Study Officials

• Christopher Chiu, BMBCh PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: September 11, 2017
• Primary Completion: May 8, 2018
• Study Completion: February 28, 2019
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)