A Respiratory Syncytial Virus (RSV) vaccine study for older adults

Trial ID: NCT04528719

A research study conducted by Moderna is testing an investigational vaccine that may protect people from RSV. RSV is a common cause of respiratory tract infection and may cause severe disease, especially in younger children and older adults.

Trial Details

The mRNA-1345-P101 study is evaluating the safety and immune response of an investigational vaccine, called mRNA-1345, to protect against RSV.

RSV can cause infections of the lungs and respiratory tract. Symptoms can be similar to a cold, and may include runny nose, sore throat, cough, and headache. However, RSV can lead to serious conditions like pneumonia especially for younger children and older adults. Currently there is not an approved vaccination for RSV.

Estimated Enrollment

Study volunteers between the ages of 65-79 years, currently enrolling 300 Participants

Phase

1

Eligibility Criteria

Participants must:

Be between 65 and 79 years old
Be in good health

Participants must not:

Have particiapated in another study in the past month
Have had cancer in the past 10 years (other than non-melanoma skin cancer or early stage cervical cancer)

What to Expect

Participation in the mRNA-1345-P101 study lasts approximately two years and includes phone calls, telemedicine visits, and up to fourteen visits to the study site.

You will be given two injections in the upper arm – the initial vaccination and a booster shot one year later. You have a chance of receiving either the mRNA-1345 study vaccine or the placebo. By using a placebo, medical researchers are able to understand if the study vaccine is effective in generating high levels of antibodies against RSV.
After each vaccination, you will be asked to return to the study site five to six times over the next year. You will have one telemedicine visit with the study doctor after each injection to monitor for any symptoms. During these phone calls, the study doctor and medical staff will check how you are feeling and ask for updates on your health.
You will be asked to use an eDiary app on your smartphone or a provided smartphone to report any symptoms you might experience 7 days after vaccination.
You will be closely monitored by the study clinic team if any symptoms are reported at any time throughout your participation.

Insurance is not needed to join this clinical trial, and compensation for your time will be available.

Frequently Asked Questions (FAQs)

What is Respiratory Syncytial Virus (RSV)?

RSV is a virus that can cause infections of the lungs and respiratory tract. Symptoms can be similar to a cold, and may include runny nose, sore throat, cough, and headache. RSV can lead to serious conditions like pneumonia, especially for younger children and older adults.

What is a clinical research study?

Clinical research studies include scientifically evaluated plans, or protocols, that outline how to test if a potential new medication or vaccine is safe and/or effective in people. All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities. A clinical research study is conducted by doctors and researchers who follow strict guidelines to ensure the safety and wellbeing of the study volunteers who participate. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.

What are the phases of clinical research?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help 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 study 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 study 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

Why is diversity important in clinical trials?

Clinical research studies and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical research study include children of all ages, genders, races and ethnicities to ensure the vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Yes, compensation for your family’s time will be available. We realize it takes time to come for study visits, so we want to make sure this is not too much of a burden for you and your child. The study site will review these details with you.

Does the mRNA-1345 study vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1345 study 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 RSV.

What is a placebo?

In order to understand if the study vaccine works, medical researchers are comparing the mRNA-1345 study vaccine to a saltwater placebo. A placebo looks like the study vaccine being tested but does not contain the study vaccine.

How can I check to see if I am eligible for this trial?

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.

Can I quit the trial at any time?

You have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the volunteer’s safety, or if the study volunteer no longer meets the study requirements.

This trial is not actively recruiting.