A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers

NCT04372719 | Completed Phase 1 DMC

• 1 other identifier: CHAMP-H3N2
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a non-controlled, open-label, single-centre, dose-escalation study to determine the safety, infectivity and immunology of the potential novel influenza virus H3N2 challenge strain. The term 'challenge agent' used in this protocol refers to the Influenza virus H3N2 A/Belgium/4217/2015. The study utilises an adaptive study design and consists of 2 parts.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (3)

• safety profile

  Number of subjects with SAEs considered by the Investigator to be related to the challenge agent, moderate or severe lower respiratory symptoms as indicated on the symptom score card, or confirmed cytokine-related AEs.

  through study completion, an average of 3 months

• Efficacy: Infectivity

  Attack rate defined as number of inoculated subjects with any of the following: * Fever * At least one other (i.e., not fever) influenza symptom At least 2 consecutive swabs positive for H3N2

  through study completion, an average of 3 months

• Efficacy: observed attack rate

  Observed attack rate expressed in percentage

  through study completion, an average of 3 months

Secondary Outcomes (1)

• Safety: Incidence of Related virus-emergent adverse events

  through study completion, an average of 1 year

Study Arms (1)

H3N2 10EXP5 TCID50/mL

EXPERIMENTAL

A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain

Drug: H3N2

Interventions

H3N2 DRUG

H3N2 10EXP5 TCID50/mL

Eligibility Criteria

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

You may qualify if:

• Male or female, between 18 and 55 years old (extremes included) at screening.
• In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening.
• Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by a MNT titre of ≤ 20 at screening.
• Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site.
• Negative alcohol breath test
• Female subjects should fulfil one of the following criteria:
• At least 1 year post-menopausal (amenorrhea \>12 months and/or follicle-stimulating hormone (FSH) \> 30 mIU/mL) prior to screening;
• Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
• Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge.

You may not qualify if:

• Subjects who have received any vaccination within the last 3 months prior to screening or influenza vaccine within the last 12 months prior to screening or who anticipate receiving this during the study.
• Subjects with a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 6 months prior to screening.
• Subjects with a positive result for adventitious agent screening (qualitative PCR testing) for any respiratory virus or bacteria on Day -2.
• Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG outside the reference range for the population studied and considered as clinical significant by the Investigator.
• Has an acute or chronic medical condition

Sponsors & Collaborators

• SGS Life Sciences, a division of SGS Belgium NV: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: single group

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 4, 2020
• Study Start: November 2, 2016
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share