A clinical trial for investigational RSV & hMPV vaccines for babies and young children

Respiratory syncytial virus (RSV) is a virus that can cause infections of the lungs and respiratory tract. RSV is the leading cause of acute lower respiratory infections in children worldwide, and most individuals are infected at least once by the age of 2. Symptoms can be like a cold, and may include a runny nose, sore throat, cough, and headache. RSV can lead to serious conditions like pneumonia, especially in young children and older adults. In 2019, RSV was associated with over 100,000 deaths of children across the world.

Human metapneumovirus (hMPV) is a frequent cause of upper and lower respiratory tract infections (RTIs) in children, with most people being exposed by the age of 5. 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 disproportionately impacted. There are no approved preventative vaccines for hMPV.

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

• Is the investigational treatment or vaccine safe enough to outweigh the risks?
• What is the best dose needed for the investigational treatment or vaccine to work?
• How often should the investigational treatment or vaccine be given?
• How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

• In Phase 1 trials, researchers test a new vaccine, drug, or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase 2 trials, the investigational vaccine, drug, or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
• In Phase 3 trials, the investigational vaccine, drug, or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

Reference: https://www.ciscrp.org/education-center/important-information/#faq

In order to understand if the investigational vaccine works, medical researchers are comparing the mRNA-1345 and mRNA-1365 investigational vaccines to a saltwater placebo. A placebo looks like the investigational vaccines but does not contain any active ingredients.

Every clinical trial participant will receive the same level of quality care regardless of whether they are assigned to an investigational vaccine or the placebo.

Clinical trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.

Given that different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, sexes, races, and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Compensation for your trial-related time may be provided.

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1345 and mRNA-1365 investigational vaccines are different. They are made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that will hopefully help the body’s immune system protect itself if you ever come in contact with RSV or hMPV. You cannot get RSV or hMPV from the investigational mRNA-1345 or mRNA-1365 vaccines.

You can check if your child is potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Participation is voluntary. You have the right to end your child’s participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.