This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

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.

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)