Phase 2/3 study of mRNA-1345 as an RSV vaccine in adults ≥ 60 years

• Research type

  Research Study

• Full title

  A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥ 60 Years of Age

• IRAS ID

  1004704

• Contact name

  Laila El Asmar

• Contact email

  Laila.El.Asmar@modernatx.com

• Sponsor organisation

  ModernaTX, Inc.

• Eudract number

  2021-005026-20

• Clinicaltrials.gov Identifier

  NCT05127434

• Research summary

  Respiratory Syncytial Virus (RSV) is a contagious disease that infects the respiratory tract. Symptoms include a runny nose, blocked nose, wheezing, cough and fever. Anyone can be infected by RSV, however, it is more serious in older adults and infants
  Vaccines prepare your immune system for fighting illnesses by causing your body to make antibodies. Antibodies are special proteins in the blood help to protect you from infectious diseases caused by bacteria and viruses. The use of a safe and effective vaccine may potentially prevent RSV infection. However, there is currently no approved vaccine to prevent RSV infection
  The mRNA-1345 vaccine is an investigational vaccine that is currently being developed by ModernaTX, Inc. to prevent RSV but is not yet approved by any regulatory agencies. This vaccine is a messenger RNA (mRNA) vaccine, in which part of the virus’ genetic information is given. The mRNA is made in a laboratory and cannot cause infection as it is not made from RSV. When the vaccine is injected into the body it makes proteins similar to those found in RSV. The body’s immune system then recognises these proteins and can generate antibodies to fight against the virus if it enters the body in the future
  The aim of this study is to determine if mRNA-1345 can prevent RSV infection and to understand its safety
  The study involves 2 phases where participants will be randomly assigned to receive either a single dose of mRNA-1345 or placebo; Phase 2 will involve 400-2000 participants and Phase 3 will involve 32000-33600 participants. All participants will be ≥60 years old and will be on the study for approximately 25 months and have 50% chance of receiving the vaccine or placebo. The placebo in the study will be a saline (salt-water) solution that does not have any investigational product in it. This will help to show any potential side effects of mRNA-1345
  Participants will have 8 scheduled visits during the study where tests/questionnaires will be completed

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  22/NW/0107

• Date of REC Opinion

  20 May 2022

• REC opinion

  Further Information Favourable Opinion