Phase 1/2 mRNA-1018-P101 Pandemic Influenza Vaccines in healthy adults aged ≥18 years

• Research type

  Research Study

• Full title

  Phase 1/2, randomized, observer-blind, parallel, dose-ranging study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age

• IRAS ID

  1007337

• Contact name

  Brett Leav

• Contact email

  brett.leav@modernatx.com

• Sponsor organisation

  ModernaTX, Inc.

• Research summary

  Pandemic influenza viruses are characterised by their tendency to change rapidly, an ability to spread easily, and the routes of transmission, which contribute to the difficulty in containing an infectious global outbreak. Influenza A viruses are most likely to cause influenza pandemics due to a large reservoir of these viruses in animal populations, particularly avian and swine, to which humans have no immunity. Compared to seasonal influenza, population immunity to the new influenza A virus is non-existent or sufficiently low to facilitate rapid person-to-person transmission and increase severity of illness among those infected, which is generally associated with higher rates of illness and death.
  There is an urgent need for vaccine technologies with rapid, high-volume manufacturing with the precision and flexibility of antigen design that are unique features of mRNA vaccines, which will allow for fast and effective responses to emerging pandemic threats.
  ModernaTX, Inc. is developing mRNA-1018, mRNA-based vaccine candidates, to prevent disease caused by pandemic influenza A Group 1 (H5N8) or Group 2 (H7N9) virus. The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data for the mRNA-1018 vaccine candidates to enable the initiation of a large Phase 3 study with one selected vaccine candidate.

  Approximately 1200 adult volunteer participants from the UK and the USA will participate in the study for approximately 7 months. Participants will have up to 8 hospital clinic visits and receive 2 doses of a randomly assigned vaccine candidate (same vaccine and dose each time). Participants will have blood and urine tests, physical exams, vital sign and heart activity measurements (electrocardiograms), and complete diaries and questionnaires.

• REC name

  North East - York Research Ethics Committee

• REC reference

  23/NE/0106

• Date of REC Opinion

  26 Jul 2023

• REC opinion

  Further Information Favourable Opinion