A Phase IIb study on the efficacy of FLU-v
Research type
Research Study
Full title
Phase IIb Study of the Efficacy of FLU-v, a Broad Spectrum Influenza Vaccine in an H1N1 Influenza Healthy Human Challenge Model
IRAS ID
209515
Contact name
Gregory Stoloff
Contact email
Sponsor organisation
PepTcell Limited (t/a SEEK)
Eudract number
2016-002134-74
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
This is a Phase 2 study, to look at the prophylactic efficacy of an experimental drug in the form of a vaccine called FLU-v. The vaccine will be administered to the participants 6 weeks prior to being infected with Influenza A/California/04/2009 (H1N1) virus. Up to 123 participants will receive the study virus in this research study.
The study consists of 4 parts: Screening, Vaccination, Quarantine Phase and Follow-Up.
Screening will take place up to 90 days before quarantine where serosuitable participants will be asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.The Vaccination phase will be carried out twice, where the participants will be checked to ensure they remain healthy and eligible to continue on the study to receive either 1 or 2 doses of FLU-v or the placebo.
Two days prior to the day of inoculation with challenge virus, participants will be admitted to the Quarantine phase, where their eligibility will be reassessed. If eligible, the participants will stay in their individual rooms for approximately 10 days. Participants may be discharged from the Quarantine unit later if they have been infected by the study virus and the virus can still be detected in their nose or if they are unwell. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine.
The participants will attend a follow-up 35 (±3) days following discharge from quarantine. Their final scheduled followup will be held on day 63 (±5), post viral challenge. Their symptoms will be reassessed by a physician and a complete safety examination performed.
The total duration of the clinical phase of the study, from the start of volunteer screening to the last participant’s last scheduled visit (LSLV) is expected to be approximately 22 weeks.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0227
Date of REC Opinion
18 Jul 2016
REC opinion
Further Information Favourable Opinion