Phase 2a study of the safety and efficacy of the vaccines modRNA and saRNA in an influenza challenge
Research type
Research Study
Full title
A Phase 2a, Randomised, Double-blind, External Placebo-controlled and Internal Comparator-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of Influenza Virus Vaccines (modRNA and saRNA) in a Human Viral Challenge Model in Healthy Adult Participants
IRAS ID
1006279
Contact name
Alex Mann
Contact email
Sponsor organisation
hVIVO Services Ltd.
ISRCTN Number
ISRCTN13789612
Research summary
The purpose of this study is to investigate the efficacy and safety of vaccination with Nucleoside-modified Messenger Ribonucleic Acid (ModRNA) and Self-amplifying Ribonucleic Acid (SaRNA) vaccines in preventing infection with A/Delaware/55/2019 (H1N1) influenza virus compared to an external placebo group and a licenced flu vaccine (quadrivalent influenza vaccines (QIV)). Up to 240 participants will be enrolled onto the study. Each participant will remain in the study for about 5 months from screening until their last follow-up visit.
The study is divided into 4 phases:
1) Screening phase: Screening will occur between Day -90 to Day -30. Historical generic screening data collected through the hVIVO generic screening process may be transferred to this study after the study-specific consent form has been signed by the participant.
2) Vaccination phase: Participants will be invited to clinic to be randomly allocated to receive a single intramuscular dose of either:
Part A: QIV or Monovalent modRNA vaccine preparation.
Part B: 2 out 3 of the following; bivalent saRNA vaccine, monovalent saRNA vaccine or a bivalent modRNA vaccine preparations will be used.
Participants are invited to attend clinic visits 1, 3 and 8 days after vaccination, with a telephone follow-up 14 days post vaccination.
3) Quarantine phase: Participants will stay in the quarantine unit for approximately 11 days (from Day -2 to Day 8). Two days prior to the day of inoculation with influenza, participants will be admitted to quarantine where their eligibility will be reassessed and inoculated with influenza on day 0. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine. Participants will be discharged from the quarantine unit on Day 8.
4) Outpatient phase: Final follow-up visit 28 days (±3 days) after the day they receive the virus. Their symptoms will be reassessed, and a complete safety examination performed.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0742
Date of REC Opinion
9 Dec 2022
REC opinion
Further Information Favourable Opinion