National Foundation for Infectious Diseases
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A Respiratory Syncytial Virus (RSV) vaccine study for older adults of Japanese descent

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 like pneumonia, especially in younger children and older adults.

Trial ID: NCT04528719

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.

Globally, RSV is responsible for millions of lower respiratory tract infections and hospitalizations. In Asia, RSV is reported to be a common cause of respiratory tract infections. Despite this high disease burden, there is limited information on RSV in Asia. By including participants of Japanese descent in this clinical trial, we can better understand RSV in this population and enable further research globally.

Estimated Enrollment

25 Participants

Phase

1

Eligibility Criteria

Participants must:
  • Be of Japanese descent (both parents and grandparents were born in Japan)
  • Be 60 years of age or older
  • Be in good health
Participants must not:
  • Have participated 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)

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We’ll check to see if you are eligible by asking you some questions.

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What to Expect

Participation in the mRNA-1345-P101 study lasts approximately six months and includes one phone call and up to nine visits to the study site.

  • Participants will be given one injection in the upper arm. Participants have a chance of receiving either the mRNA-1345 investigational vaccine or the placebo. This random assignment will be a 4:1 ratio, meaning there is an 80% chance of receiving the study vaccine. By using a placebo, medical researchers are able to understand if the investigational vaccine is effective in generating high levels of antibodies against RSV.
  • Participants will have one phone call with the study doctor after the injection to discuss for any side effects.
  • Participants will be asked to use an eDiary app on their smartphone or a smartphone will be provided to report any symptoms the participant might experience for 7 days after the injection.
  • Participants will be closely monitored by the study clinic team if any symptoms are reported at any time throughout their participation.

Insurance is not needed to join this clinical trial, and compensation for the participants time will be provided.

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Actively Recruiting

  • Honolulu, Hawaii, United States
  • Los Angeles, California, United States

Frequently Asked Questions (FAQs)

Check Eligibility

We’ll check to see if you are eligible by asking you some questions.

Get Started