National Foundation for Infectious Diseases

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This trial is not actively recruiting.

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

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

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)

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)

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, or clinical research studies, 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 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 investigational 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 participants quit the trial at any time?

Participants 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 participant at any time for the participant’s safety, or if the participant no longer meets the study requirements.