Background
The RHYME study is a Phase 1 clinical trial involving 120 babies from 5 to 7 months old. It aims to evaluate the safety and immune response to two vaccines developed to prevent respiratory infections caused by 2 common viruses: Respiratory Syncytial Virus (RSV) and Human metapneumovirus (hMPV).
RSV is a common virus that infects the lungs and respiratory tract – the parts of the body related to breathing. It can cause a runny nose, sore throat, cough, and headache. RSV is the most common cause of lower respiratory tract infections in children around the world. RSV can lead to serious respiratory tract problems like pneumonia, especially in young children. In 2019, RSV was associated with over 100,000 deaths of children across the world, the majority of these in developing countries. In Australia, the burden of disease is mainly from lower respiratory infections, leading to hospitalisations.
hMPV is a common cause of upper and lower respiratory tract infections in children, with most being exposed by the age of 5 years. It causes symptoms similar to a cold. It can lead to more serious infections, such as pneumonia. Globally, an estimated 11.1 million acute lower respiratory infections, 502,000 hospital admissions, and 11,300 deaths were attributed to hMPV in 2018, with those under 12 months of age being particularly affected. There are no approved vaccines to prevent hMPV.
The vaccines used in the study
mRNA-1345: A study vaccine designed to prevent infections caused by RSV. This vaccine has been given to over 15,000 adults, and to approximately 30 children aged 1 to 5 years in other studies.
mRNA-1365: A study vaccine designed to prevent both RSV and hMPV. The hMPV part of this vaccine has been given to approximately 100 adults and approximately 15 children aged 1 to 5 years in other studies of a vaccine to prevent both hMPV and parainfluenza (another virus). The RSV component of this vaccine is the same as mRNA-1345.
Placebo: Looks like the study vaccine but has no active ingredient in it. Researchers compare the study vaccines to a placebo to learn if any effects are really due to the study vaccines.
What does joining the study mean?
Your child will get 3 doses of their randomly assigned study vaccine (one of the three listed above) in the course of the study.
There will be a total of 9 scheduled in-person study visits which would usually involve a review of your child’s health, administration of a dose of the vaccine, and/or collection of a blood sample. There will be 4 blood collections each occurring in separate visits.
30 minutes after your child receives the study vaccine, you will be required to complete the eDiary once a day, preferably in the evening from the day of vaccination and for 6 days after each vaccination.
Apart from these, we will check up on your child through several safety phone calls. Should your child develop symptoms of RSV and hMPV or any possible side effects of the vaccine, an additional visit may be scheduled to follow-up on your child.
Funding
This research study is being conducted by ModernaTX, Inc and sponsored in Australia by Parexel International Pty Ltd and is being funded by ModernaTX, Inc.
Ethics
All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by Child and Adolescent Health Service Human Research Ethics Committee.
Moderna website specific to trial: