Phase 2a study of the safety and efficacy of the vaccines modRNA in an influenza B challenge model
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Comparator-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity, of Influenza Virus Vaccines (modRNA) in a Human Influenza B Challenge Model in Healthy Adult Participants.
IRAS ID
1008256
Contact name
Alex Mann
Contact email
Sponsor organisation
hVIVO Services Ltd.
ISRCTN Number
ISRCTN13559330
Research summary
This is a Phase 2a study to assess the efficacy, safety, and immunogenicity of a single vaccination with nucleoside-modified messenger ribonucleic acid (modRNA) vaccines administered to healthy adults, prior to being challenged with influenza B/Connecticut/1/21 virus. The vaccine arms from this study will be compared against placebo. In addition, a licensed QIV will be used as a comparator in this 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 -120 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 1 of 4 treatment arms to receive a single intramuscular dose of Licensed QIV (Flucelvax Tetra) or Placebo or modRNA QIV, or 1 of 2 of the following selected vaccines; qIRV HA + NA preparation or modRNA monovalent HA. Participants are invited to attend clinic visits 3 and 8 days after vaccination, with telephone follow-up 1 day and 14 days post vaccination.
3) Quarantine phase: Participants will stay in the quarantine unit for approximately 11 days (from Day -2/-1 to Day 8). One to 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 (or may remain longer PI's discretion).
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
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0236
Date of REC Opinion
15 Nov 2023
REC opinion
Further Information Favourable Opinion