Influenza Flu
Conditions
Interventions
A/Tasmania/503/2020 (H3N2) influenza virus, that was isolated from a patient and amplified according to good manufacturing practices (GMP). Inoculation will be performed according to CHDR Standard Ope
TCID50 in 1 mL, administered as droplets and divided between both nostrils. Doses will be escalated by log10 for every dose group
the maximum dose is 106 TCID50.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age 18-45 (inclusive) years;Good health, based upon the results of medical history, physical examination, vital signs, ECG, and laboratory profiles of both blood and urine;Participant is psychologically fit and able to remain in the inpatient Isolation Unit up until 14 days after inoculation, assessed by questionnaires at screening, and judged by the investigator. A score of 5 or higher on the GAD-7 or PHQ-9, and a score of 3 or higher on the PDSS leads to exclusion;Seronegative (defined as a strain-specific hemagglutination inhibition titre <10) for pre-existing neutralizing influenza antibodies at screening;Willingness to adhere to study procedures and to remain in the inpatient isolation unit up until 14 days after inoculation and willing to stay in self-quarantine until no longer infectious to others, based on the clinical assessment by the Investigator;
Exclusion criteria
Exclusion criteria: Share household, work closely or have close contact with infants/children (<4 years of age), pregnant women, people with respiratory diseases (e.g. asthma, COPD), immune-compromised people and/or clinically vulnerable elderly (=65 years old) individuals for 30 days after influenza inoculation;Any confirmed or suspected disease or condition associated with immune system impairment, including auto-immune diseases, HIV, asplenia or recurrent severe infections; Any history of physician-diagnosed and/or objective test-confirmed asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, or chronic lung condition of any aetiology.Nasopharyngeal swab indicative for influenza and/or other respiratory virus infection, determined by PCR at baseline visit (Day -1);Smokers or ex-smokers with more or equal to 5 pack years smoking history, including e-cigarettes;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish a CHIM with the GMP-produced A/Tasmania/503/2020 (H3N2) influenza virus, for future drug and vaccine development. To identify the inoculation dose needed to induce influenza disease* with a new strain in 70% of exposed healthy adult volunteers.To investigate the safety and tolerability of controlled infection after inoculation with the GMP-produced A/Tasmania/503/2020 (H3N2) influenza virus. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess influenza virus kinetics in nasopharyngeal swab.To assess clinical symptoms of influenza disease from self-reported standardized symptom scales.To evaluate the systemic immune response after inoculation with the challenge strain. | — |
Countries
Netherlands
Contacts
Public ContactI.M.C. Visser-Kameling
Centre for Human Drug Research
Outcome results
None listed