A Respiratory Syncytial Virus (RSV) vaccine clinical trial for older adults

Trial ID: NCT05127434

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-P301 study is evaluating the safety and efficacy 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

34,000 Participants

Phase

2/3

Eligibility Criteria

Participants must:

Be at least 60 years old
Be in generally good health; certain chronic diseases such as heart failure and chronic obstructive pulmonary disease may be permissible
Be primarily responsible for self-care (do not require a caretaker)

Participants must not:

Have participated in another trial within the past 45 days
Have received a vaccination or donated blood in the past month

What to Expect

Sites are located in the cities/states identified with the red pin:

The total length of participation in this clinical trial is approximately 2 years (25 months). It includes up to 8 trial visits and 26 brief communications (via telephone, email, or text message). You may have the option for some of the trial visits to be completed at home with a mobile health provider or through a video visit. Your trial doctor will discuss these options with you.

Clinical trial volunteers will have a screening visit to check whether they are eligible to participate. If they are eligible and choose to participate, they will have 7 more trial visits over the next 2 years.
Clinical trial participants will be given one injection in the upper arm
Each clinical trial participant has a 50% chance of receiving the investigational vaccine and a 50% chance of receiving the placebo – like flipping a coin.
- A placebo does not contain any active ingredients

Participation in the mRNA-1345-P301 study lasts approximately two years and includes phone calls, telemedicine visits, and up to eight visits to the study site.

You will be given one injection in the upper arm. 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 the study injection, 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 trial?

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 the FDA and other regulatory agencies in order to ensure patients’ and trial volunteers’ safety. The protocol outlines the types of trial participants to include, the schedule of study visits and procedures, safety precautions, and what and how study data will be analyzed.

What are the phases of clinical research?

All new treatments and vaccines must go through several stages of research (also called “phases”) in order to determine if the new treatment or vaccine is safe and effective in people. Clinical trials are usually conducted in four phases that build on one another, with each phase designed to answer certain questions.

Preclinical Research: Before testing in people, investigational treatments undergo laboratory and animal testing to answer basic questions about safety.
Phase 1: A trial of a small number of participants to evaluate the safety and dosage of an investigational treatment or vaccine and gather information on how it interacts with the body.
Phase 2: A trial of a slightly larger group of participants to further evaluate how an investigational treatment or vaccine affects the body, gather additional safety data, and monitor side effects.
Phase 3: A trial with the largest number of participants to determine efficacy of an investigational treatment or vaccine and compare it to existing treatments, vaccines, or placebos. A Phase 3 trial continues to monitor side effects and collect safety data. This is the final step before submitting an investigational product to a regulatory agency for market approval.
Regulatory Agency Review: Regulatory agencies, such as the FDA in the United States, review data from the clinical trial and determine if the investigational treatment or vaccine is effective and safe for use in people. To get approved, the new treatment or vaccine must be determined to provide benefits that outweigh its known and potential risks for the intended population.
Phase 4: After receiving approval, the treatment is made available for use. Phase 4 trials are used for post-marketing observation. Sometimes, they may be used to study the medicine in a different group of people or in another illness or disease than was previously studied. Not all medications and treatments will require a Phase 4 trial.

Reference: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Why is diversity important in clinical trials?

Clinical trials 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 people 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 participants’ time will be available. The study site will review these details with the participants.

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 comparator or placebo?

In order to better know if the investigational treatment or vaccine works, researchers may compare the investigational treatment or vaccine to an inactive drug called a placebo, which can be a sugar pill or saltwater solution. A placebo looks like the investigational treatment or 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 treatment or vaccine, or the placebo.

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 participants quit the trial at any time?

Participation in any clinical trial is completely voluntary. Participants have the right to drop out of the trial at any time and for any reason (and they do not need to give a reason). The study doctor or sponsor also has the right to discontinue a participant at any time for the participant’s safety or if the participant no longer meets the clinical trial requirements.

This trial is not actively recruiting.