A platform study to characterize respiratory challenge agents in healthy male and female adult participants
| ISRCTN | ISRCTN16102371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16102371 |
| IRAS number | 348061 |
- Submission date
- 04/12/2024
- Registration date
- 20/01/2025
- Last edited
- 20/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This is a study where healthy male and female adults aged between 18-64 years will be exposed to different respiratory viruses to understand how these viruses affect them. The aim is to find the right amount of virus that is both safe and can cause an infection, so it can be used in future research. The study will follow a specific protocol that applies to all virus tests, with additional details for each specific virus.
Who can participate?
This study is for healthy adults men and women aged 18 to 64 years as per ISA requirements. Participants must meet specific health criteria, which will be checked during a screening process.
What does the study involve:
This is an exploratory platform study to investigate the dose, pathogenicity, immunogenicity, transmission potential, and safety of multiple study interventions.
The master protocol will define the common study inclusion/exclusion criteria, common visits and data assessments. An Intervention-Specific Appendix (ISA) will define the specific requirements for the intervention being evaluated.
The platform study consists of the following phases:
1. Screening: Participants are screened before quarantine admission to confirm their suitability to take part in the study.
2. Quarantine: Participants will stay in the quarantine unit as defined in the ISA. This phase includes:
2.1. Quarantine admission
2.2. Participants receive the challenge agent
2.3. After receiving the virus: Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in the quarantine unit.
3. Outpatient phase: A follow-up visit will occur after virus inoculation as per ISA requirements.
Individual participation lasts up to 28 days, though some participants may need to follow up for a longer period depending on the virus they are exposed to.
What are the possible benefits and risks of participating?
Participants may help advance medical research into respiratory diseases. They will receive regular medical care and monitoring during the study.
As with any study involving viruses, there is a risk of contracting mild to moderate illness from the challenge agent. Participants will be closely monitored, and safety measures will be in place. Specific risks will vary depending on which virus they are exposed to, and these will be detailed in the study documentation.
Where is the study run from?
hVIVO Services Limited (UK)
When is the study starting and how long is it expected to run for?
August 2024 to October 2029
Who is funding the study?
hVIVO Services Limited (UK)
Who is the main contact?
1. Dr Nikolay Veselinski, n.veselinski@hvivo.com
2. Alex Mann, a.mann@hvivo.com
Contact information
Public
40 Bank Street
Canary Wharf
London
E14 5NR
United Kingdom
| Phone | +44 (0)20 7756 1300 |
|---|---|
| s.aftab@hvivo.com |
Principal Investigator
40 Bank Street
Canary Wharf
London
E14 5NR
United Kingdom
| Phone | +44 (0)20 7756 1300 |
|---|---|
| n.veselinski@hvivo.com |
Scientific
40 Bank Street
Canary Wharf
London
E14 5NR
United Kingdom
| Phone | +44 (0)20 7756 1300 |
|---|---|
| a.mann@hvivo.com |
Study information
| Study design | Single-centre open-label platform study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomized as per ISA |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | A platform study to characterize respiratory challenge agents in healthy male and female adult participants |
| Study objectives | 1. Experimental infection with respiratory challenge agent(s) in healthy adults is safe and well tolerated. 2. Experimental infection with respiratory challenge agent(s) allows pathogen replication and signs and symptoms of disease to be measured and the election of a preferred dose for future interventional studies. |
| Ethics approval(s) |
Approved 07/10/2024, London - London Bridge Research Ethics Committee (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)207 104 8229; londonbridge.rec@hra.nhs.uk), ref: 24/LO/0717 |
| Health condition(s) or problem(s) studied | Influenza viruses, respiratory syncytial viruses (RSV), human metapneumoviruses (hmPV), rhinoviruses |
| Intervention | 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 disease type looking to evaluate multiple challenge agents. The study challenge agents being evaluated as part of the platform study include influenza (H3N2, H1N1, and B viruses), respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and rhinoviruses (RVs). The primary goal of this platform study is to characterize multiple challenge agents and establish the optimal dose of the respective agent that is safe and infectious in healthy adults. The platform study is defined by the master protocol, which governs the entire study and includes the common key study design elements for the interventions (challenge agent) being evaluated and the Intervention-Specific Appendix (ISA) supplements the master protocol by detailing the specific features of each challenge agent. Together, the master protocol and ISA provide the necessary information to conduct each intervention cohort. The platform study will not exceed a total of 1000 participants. While the platform study is an open-label study, blinding and randomization may be included in the ISA to prevent the occurrence of conscious and unconscious bias in the conduct and interpretation of the study, as relevant. The platform study consists of the below phases: 1. Screening: Participants are screened prior to quarantine admission to confirm suitability to take part in the study. 2. Quarantine: Participants will stay in the quarantine unit as defined in the ISA. This phase includes: 2.1. Quarantine admission 2.2. Participants receive the challenge agent 2.3. Post receiving virus: Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in the quarantine unit. 3. Outpatient phase: A follow-up visit will occur post virus inoculation as per ISA requirements. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Non-IMP |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | hMPV (human metapneumovirus), RSV Memphis (rhinovirus), RSV London (rhinovirus), influenza virus |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/08/2024 |
| Completion date | 19/10/2029 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/09/2024 |
| Date of final enrolment | 24/09/2029 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Canary Wharf
London
E14 5NR
United Kingdom
Sponsor information
Research organisation
40 Bank Street
Canary Wharf
London
E14 5NR
England
United Kingdom
| Phone | +44 (0)20 7756 1300 |
|---|---|
| a.mann@hvivo.com | |
| Website | http://hvivo.com/ |
"ROR" |
https://ror.org/00a4k5f23 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 28/02/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website |
| IPD sharing plan | No plan for individual participant data sharing plan |
Editorial Notes
07/01/2025: Study's existence confirmed by London - London Bridge Research Ethics Committee.
