Influenza Challenge Study in Healthy Volunteers

NCT02746211 | Completed Phase 1

• 1 other identifier: RIS-110 (DEE-CS-002)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection.

Conditions

Influenza

Keywords

immunology; pathogenicity

Outcome Measures

Primary Outcomes (1)

• The infection rate of an Influenza (A/New Caledonia/20/99) virus. in human volunteers

  14 days

Secondary Outcomes (2)

• Self Reported Symptoms

  14 days

• Virus Shedding from Nasal Mucosa

  14 days

Study Arms (4)

High Titre Influenza virus

EXPERIMENTAL

High Titre Influenza virus

Biological: High Titre Influenza virus

Medium - High Influenza virus

EXPERIMENTAL

Medium - High Influenza virus

Biological: Medium - High Influenza virus

Medium Low Titre Influenza virus

EXPERIMENTAL

Medium Low Titre Influenza virus

Biological: Medium Low Titre Influenza virus

Low titre Influenza Vaccine

EXPERIMENTAL

Low titre Influenza Vaccine

Biological: Low titre

Interventions

High Titre Influenza virus BIOLOGICAL

High Titre Influenza virus

High Titre Influenza virus

Medium - High Influenza virus BIOLOGICAL

Medium - High Influenza virus

Medium - High Influenza virus

Medium Low Titre Influenza virus BIOLOGICAL

Medium Low Titre Influenza virus

Medium Low Titre Influenza virus

Low titre BIOLOGICAL

Low titre

Low titre Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 45 years, inclusive.
• Comprehension of the study requirements;availability for the required study period, ability to attend scheduled study visits, and willingness to participate in the inpatient challenge.
• Willingness to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
• Good general health status as determined by a screening evaluation no greater than 45 days prior to the quarantine and challenge phase.
• For female subjects, provision of a history of reliable contraceptive practices \[hysterectomy or bilateral tubal ligation, oral or implanted contraceptive use, intrauterine device, barrier method plus spermicide, history of a single male partner with vasectomy, or a history of abstinence deemed credible by the investigator(s)\]. The provision of this history does NOT replace the requirement to perform, and obtain negative results in, pregnancy tests.

You may not qualify if:

• Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness,
• Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge. Healthcare workers who volunteer should not work with patients until 14 days after challenge or until their symptoms are fully resolved.
• Venous access deemed inadequate for the phlebotomy demands of the study.
• Positive serologic tests for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
• Evidence of drug abuse or a positive urine Class A drug or alcohol screen.
• Female subjects, who are known to be pregnant or who have a positive urine β-HCG detected prior to challenge.
• Chronic use of any medication or other product (prescription or over-the-counter), for symptoms of rhinitis or nasal congestion or for any chronic nasopharyngeal complaint, or chronic use of any intranasal medication for any indication.
• Any history during adulthood of asthma of any etiology (chronic obstructive pulmonary disease), or any use of a bronchodilator or other asthma medication within adulthood.
• Smokers unwilling/unable to desist for the quarantine phase duration of the study.
• Subject is type I or type II diabetic.
• Subject is allergic to Gentamicin.
• Acute use of any medication or other product, prescription or over-the-counter, for symptoms of rhinitis or nasal congestion within seven (7) days prior to challenge. This includes any corticosteroid or beta agonist containing nasal spray.
• An Abnormal ECG deemed clinically relevant by the Investigator(s).
• Any anatomic or neurologic abnormality impairing the gag reflex or conducive to aspiration, or history suggestive of such a problem or any abnormality significantly altering the anatomy of the nose or nasopharynx.
• Receipt of systemic glucocorticoids (in a dose ≥5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months prior to challenge.

Sponsors & Collaborators

• Hvivo: lead

Study Sites (1)

hVIVO Services Ltd, QMB Bioenterprise building

London, e1 2ax, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Robert Lambkin-Williams, PhD

  020 7756 1300

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: April 21, 2016
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 21, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)