Influenza viruses, respiratory syncytial viruses (RSV), human metapneumoviruses (hmPV), rhinoviruses Infections and Infestations
Conditions
Interventions
This is a single-centre platform study to characterize respiratory challenge agents in healthy male and female adult participants. A platform study is a type of study that is set up to investigate the
Sponsors
hVIVO (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Master Protocol Inclusion Criteria: 1. Adult male or female aged between 18 and 64 years 2. A total body weight =50 kg and body mass index (BMI) =18 kg/m2 and =35 kg/m2 3. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety 4. Documented medical history 5. Adherence to contraception requirements 6. Serosuitable for the challenge virus ISA Specific Inclusion Criteria: ISA#01 INCL01-01 Aged between 18 and 55 years, inclusive, on the day prior to signing the consent form INCL01-02 Sero-suitable for the challenge agent: ISA#02 INCL02-01 Aged between 18 and 55 years, inclusive, on the day prior to signing the consent form INCL02-02 Sero-suitable for the challenge agent: ISA#03 INCL03-01 Aged between 18 and 55 years, inclusive, on the day prior to signing the consent form INCL03-02 Sero-suitable for the challenge agent
Exclusion criteria
Exclusion criteria: Master Protocol Exclusion Criteria: 1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit. 2. Any history or evidence of any clinically significant or currently active disease. 3. Any participants who have smoked =10 pack years at any time. 4. Female participants who are breastfeeding, or have been pregnant within 6 months prior to the study, or have a positive pregnancy test at any point during screening or prior to inoculation. 5. Any history of anaphylaxis and/or any history of severe allergic reaction. 6. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study. 7. Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction. 8. Significant abnormality of the nose, including loss of or alterations in smell or taste, nasal polyps, epistaxis, nasal or sinus surgery. 9. Recent vaccinations or intention to receive vaccination before the Day 28 follow-up visit. 10. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned inoculation or planned during the 3 months after the final visit. 11. Recent receipt of investigational drugs or challenge viruses. 12. Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows. 13. Positive drugs of abuse test, recent history or presence of alcohol addiction, excessive consumption of xanthine-containing substances or the presence of significant signs and symptoms of nicotine withdrawal on the first study visit. 14. A forced expiratory volume in 1 second (FEV1) <80%. 15. Positive HIV, hepatitis B virus, or hepatitis C virus test. 16. Presence of fever, defined as participant presenting with a temperature reading of =37.9°C on Day -2/-1 and/or pre-inoculation on Day 0. 17. Those employed or immediate relatives of those employed at hVIVO or the sponsor. 18. Any other reason, in the opinion of the investigator deems the participant unsuitable for the study ISA-specific Exclusion Criteria: ISA#01 EXCL01-01: Prior inoculation with the same or closely related hMPV challenge agent ISA#02 EXCL02-01: Prior inoculation with the same or closely related RSV challenge agent ISA#03 EXCL03-01: Prior inoculation with the same or closely related RSV challenge agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Occurrence of adverse events (AEs) related to the challenge agent from inoculation (Day 0) up to the Day 28 follow-up 2. Occurrence of serious adverse events (SAEs) related to the challenge agent from inoculation (Day 0) up to the Day 28 follow-up 3. Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)-confirmed infection, defined as two quantifiable (= lower limit of quantification [LLOQ]) qRT-PCR measurements reported over four planned consecutive assessments within 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Area under the viral load-time curve (VL-AUC), as determined by qRT-PCR in respiratory samples 2. Peak load of challenge agent as defined by the maximum titer determined by qRT-PCR measurements in respiratory samples 3. VL-AUC of challenge agent as determined by quantitative culture measurements in respiratory samples 4. Peak load of challenge agent as defined by the maximum titer determined by quantitative culture measurements in respiratory samples Timepoint is as per ISA, as all ISAs are not known and may vary this will not be able to be defined | — |
Countries
England, United Kingdom
Contacts
Public ContactSumreen Aftab
Outcome results
None listed