A platform study to characterize respiratory challenge agents
Research type
Research Study
Full title
A Platform Study to Characterize Respiratory Challenge Agents in Healthy Male and Female Adult Participants
IRAS ID
348061
Contact name
Nikolay Veselinski
Contact email
Sponsor organisation
hVIVO Services Ltd.
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This is a single-centre platform study to Characterize respiratory challenge agent in Healthy Male and Female Adult Participants. Primary goal of this platform study is to characterize multiple challenge agents & establish the optimal dose of the respective agent that is safe and infectious in healthy adults for use in subsequent future studies. 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 & the Intervention-Specific Appendix (ISA) supplements the master protocol by detailing the specific features of each intervention. Together, the master protocol & ISA provide the necessary information to conduct each intervention cohort. The platform study will not exceed a total of 1000 participants.
The study consists of below phases:
1.Screening: Participants are screened from Day -90 to Day -2/-1, prior to quarantine admission to confirm suitability to take part in the study.
2.Quarantine: Participants will stay in the quarantine unit for up to 17 days as defined in the ISA. This phase includes:
a. Quarantine admission (D-2/D-1). Baseline assessments/safety & eligibility checks will be performed. If participants remain eligible, they will undergo randomization (if applicable) before receiving the virus on D0.
b. Post receiving virus: Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in the quarantine unit. Participants will be discharged from the unit as per virus specific requirements outlined in the ISA. Participants may remain longer at the principal investigator's discretion.
3.Outpatient phase: A follows up visit will occur on Day28 (+/-3days). Participants will be required to attend a follow up visit approximately 11 to 20 days after they receive the virus on DO as per specific requirements outlined in the ISA. Additional follow up visits if required will be detailed in the ISA.REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0717
Date of REC Opinion
27 Sep 2024
REC opinion
Favourable Opinion