Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model

NCT02525055 | Completed Results DMC

• 1 other identifier: RVL-vCS-003
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Influenza

Keywords

Flu; Influenza; Human Viral Challenge Model; Wild-Type; H3N2; Universal Influenza Vaccine; Intra-seasonal vaccines; Antiviral

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of Virus Load

  Area under the curve (AUC) of the Challenge Viral load, measured by nasopharyngeal swab quantitative polymerase chain reaction \[qPCR\], from Day 1 to Day 8 post-Viral Challenge. Nasopharyngeal swabs are collected up to 3 times per day ( every 8 hours +/- 30mins)

  8 days

Other Outcomes (1)

• Incidence (Number and Percentage [%]) of Viral Challenge Emergent Adverse Events

  8 days

Study Arms (6)

Infectious titre 1

EXPERIMENTAL

6 participants aged 18 to 45 were inoculated with 1mL containing 2.8 x 10\*3 TCID50 of virus

Other: Infectious titre 1 (H3N2)

Infectious titre 2

EXPERIMENTAL

6 participants aged 18 to 45 were inoculated with 1mL containing 2.5 x 10\*4 TCID50 of virus

Other: Infectious titre 2 (H3N2)

Infectious titre 3

EXPERIMENTAL

6 participants aged 18 to 45 were inoculated with 1mL containing 3.6 x 10\*5 TCID50 of virus

Other: Infectious titre 3 (H3N2)

Infectious titre 4

EXPERIMENTAL

6 participants aged 18 to 45 were inoculated with 1mL containing 4.7 x 10\*6 TCID50 of virus

Other: Infectious titre 4 (H3N2)

Infectious titre 5 (age 18 to 45 y)

EXPERIMENTAL

6 participants aged 18 to 45 were inoculated with 1mL containing 3.5 x 10\*5 TCID50 of virus.

Other: Infectious titre 5 (H3N2) (Subjects aged 18 to 45 years old)

Infectious titre 5 (age 46 to 64 y)

EXPERIMENTAL

16 participants aged 46 to 64 were inoculated with 1mL containing 3.5 x 10\*5 TCID50 of virus.

Other: Infectious titre 5 (H3N2) (Subjects aged 46 to 64 years old)

Interventions

Infectious titre 1 (H3N2) OTHER

Infectious titre 1: 2.8 x 10\*3 TCID50/mL

Infectious titre 1

Infectious titre 2 (H3N2) OTHER

Infectious titre 2: 2.5 x 10\*4 TCID50/mL

Infectious titre 2

Infectious titre 3 (H3N2) OTHER

Infectious titre 3: 3.6 x 10\*5 TCID50/mL

Infectious titre 3

Infectious titre 4 (H3N2) OTHER

Infectious titre 4: 4.7 x 10\*6 TCID50/mL

Infectious titre 4

Infectious titre 5 (H3N2) (Subjects aged 18 to 45 years old) OTHER

Infectious titre 5: 3.5 x 10\*5 TCID50/mL

Infectious titre 5 (age 18 to 45 y)

Infectious titre 5 (H3N2) (Subjects aged 46 to 64 years old) OTHER

Infectious titre 5: 3.5 x 10\*5 TCID50/mL

Infectious titre 5 (age 46 to 64 y)

Eligibility Criteria

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

You may qualify if:

• In good health with no history of major medical conditions.
• A total body weight ≥ 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.

You may not qualify if:

• Subjects who have a significant history of any tobacco use at any time (≥ 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.
• Confirmed positive test for drugs of abuse.
• Venous access deemed inadequate for the phlebotomy and cannulation.
• Any known allergies to the excipients in the Challenge Virus inoculums.
• Health care workers who work in units with severely immuno-compromised patients.

Sponsors & Collaborators

• Hvivo: lead

Related Publications (2)

• Fullen DJ, Noulin N, Catchpole A, Fathi H, Murray EJ, Mann A, Eze K, Balaratnam G, Borley DW, Gilbert A, Lambkin-Williams R. Correction: Accelerating Influenza Research: Vaccines, Antivirals, Immunomodulators and Monoclonal Antibodies. The Manufacture of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model. PLoS One. 2016 Jun 9;11(6):e0157211. doi: 10.1371/journal.pone.0157211. eCollection 2016.

  PMID: 27280602 RESULT

• Fullen DJ, Noulin N, Catchpole A, Fathi H, Murray EJ, Mann A, Eze K, Balaratnam G, Borley DW, Gilbert A, Lambkin-Williams R. Accelerating Influenza Research: Vaccines, Antivirals, Immunomodulators and Monoclonal Antibodies. The Manufacture of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model. PLoS One. 2016 Jan 13;11(1):e0145902. doi: 10.1371/journal.pone.0145902. eCollection 2016.

  PMID: 26761707 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Nicolas Noulin
• Organization: hVIVO Services Limeted

n.noulin@hvivo.com

+442077561365

Study Officials

• Bryan Muray, MD

  Hvivo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cohort 1 (including 4 arms) is double blinded. Cohort 2 (including 1 arm divided in 2 separate age comparison groups) is open labelled. In order to allow for an age comparison between subjects aged 18 to 45 and subjects aged 56 to 64, data from Cohort 2 (Infectious Titre 5) will be presented in 2 separate reporting groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 17, 2015
• Study Start: January 1, 2014
• Primary Completion: August 11, 2014
• Study Completion: August 11, 2014
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01