A clinical trial for an investigational respiratory syncytial virus (RSV) vaccine combined with an investigational COVID-19 booster vaccine for older adults.

RSV is a virus that can cause infections of the lungs and respiratory tract. 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 for younger children and older adults.

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Common symptoms are similar to the flu and include fever, cough, and tiredness. More serious symptoms include difficulty breathing and loss of speech or mobility. The World Health Organization declared COVID-19 a pandemic in March 2020. Since that time, there have been more than 500 million cases and 6.2 million deaths worldwide.

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.

Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

• 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

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.

Travel expenses related to clinical trial participation will be reimbursed. The clinical trial site will review these details with you.

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1345 investigational vaccine is different. It is 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 is thought to help the body’s immune system protect itself if you ever come in contact with the respiratory syncytial virus. You cannot get RSV from the investigational mRNA-1345 vaccine.

To better know if the investigational vaccine works, researchers may compare the investigational vaccine to an inactive drug called a placebo, which can be a sugar pill or saltwater solution. A placebo looks like the investigational vaccine being tested but does not contain an active ingredient.

All participants receive the same level of quality care regardless of whether they are assigned to the investigational vaccine, or the placebo.

You can check if you are 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.

You have the right to drop out of 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.