A clinical trial of an investigational RSV vaccine for adults who have received a kidney, liver, or lung transplant

Trial ID: mRNA-1345-P303 Cohort2

The RSVoice Trial is a Phase 3 clinical trial conducted by Moderna to evaluate the safety and immune response of an investigational vaccine aimed at preventing respiratory syncytial virus (RSV) infection in adults who have received a kidney, liver, or lung transplant.

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Trial Details

The purpose of this clinical trial is to evaluate the safety and immune response of 2 doses of an investigational vaccine aimed at preventing RSV infection in adults who have a weakened immune system due to having an organ transplant. An investigational vaccine is not yet approved by a country’s drug regulatory agency. All participants in the RSVoice Trial will receive the investigational vaccine.

RSV is a common respiratory virus that infects the lungs and breathing passages. People most frequently associate RSV with the risk it brings to young children, but many do not know the high risk it poses for adults with preexisting health conditions and older adults.

People with weakened immune systems, such as those taking immunosuppressants after an organ transplant, have a higher risk of life-threatening symptoms when infected with RSV.

Estimated Enrollment

150 Participants

Phase

3

Eligibility Criteria

Participants must:

Be 18 years of age or older
Be a recipient of a kidney, liver, or lung transplant at least 6 months prior and be currently receiving chronic immunosuppressive therapy

Participants must not:

Be pregnant or planning on becoming pregnant for at least 3 months following the final vaccine visit

What to Expect

Participation in the RSVoice Trial will last approximately 2 years and includes at least 9 visits to a trial site and up to 8 safety phone calls. Additional visits may be required for certain participants.

All participants will receive the investigational vaccine, mRNA-1345.

Each participant will be given 2 injections in the upper arm, approximately 2 months apart.

After participants have received the investigational vaccine, they will routinely use a symptom-reporting electronic diary, or eDiary, to record how they are feeling.

Insurance is not needed to participate, and qualified participants will receive payment for their trial-related time and travel.

Site Locations

Participants will need to go to one of the clinics taking part in this clinical trial.

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

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 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, older adults, and those with weakened immune systems due to an organ transplant.

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 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.

What are the phases of clinical trials?

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

Why is diversity important in clinical trials?

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.

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

Qualified participants will receive payment for their trial-related time and travel.

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

The investigational vaccine being evaluated in this clinical trial is called mRNA-1345. Unlike vaccines that are made from weakened or killed viruses, mRNA-1345 is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make specific protein. The goal of this vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real respiratory syncytial virus, should it ever enter your body. You cannot get RSV from the mRNA-1345 investigational 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 remove myself from the trial at any time?

Participation is voluntary. You have the right to end your 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.