Moderna Vaccine for RSV

(RSV SB Trial)

Overseen By Sonia Tandon Wimalasena, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Must not be taking: Chemotherapy, Immunosuppressants, Corticosteroids, others

Disqualifiers: Cancer, HIV, Autoimmune, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the immune system's response to the FDA-approved Moderna RSV vaccine in individuals aged 60 and older. Researchers seek early indicators of the vaccine's effectiveness and aim to learn more about the body's defense against RSV, a virus affecting the lungs and breathing passages. Individuals aged 60 or older who meet CDC guidelines for the RSV vaccine may qualify for this study. Participants should not have severe allergies to vaccine ingredients or conditions that compromise their immune system. As a Phase 4 trial, this research explores how the already FDA-approved and effective vaccine benefits a broader patient population.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on cancer chemotherapy, immunosuppressive therapy, or high-dose corticosteroids, you may not be eligible to participate.

What is the safety track record for the Moderna RSV vaccine?

Research has shown that the Moderna RSV vaccine is safe for adults aged 60 and older. In earlier studies, people in this age group who received the vaccine usually did not experience serious side effects. The FDA approved the vaccine in May 2024, indicating it passed strict safety tests. This approval suggests that serious safety issues are unlikely, though minor side effects may occur, as with any vaccine. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard RSV vaccines, the Moderna RSV vaccine (MRESVIA) is unique because it utilizes mRNA technology to stimulate an immune response. While traditional RSV vaccines, such as those using live attenuated or inactivated viruses, focus on introducing viral proteins directly, the Moderna vaccine instructs cells to produce a protein similar to the RSV virus, teaching the immune system to recognize and fight the actual virus effectively. Researchers are excited about this approach because mRNA vaccines have shown high efficacy and rapid adaptability in other viruses, suggesting the potential for robust immune protection against RSV in older adults.

What is the effectiveness track record for the Moderna RSV vaccine in adults aged 60 and over?

Research has shown that the Moderna RSV vaccine, administered to participants in this trial, effectively prevents RSV infections. One study found the vaccine to be about 80% effective in stopping RSV symptoms during the first four months after vaccination. Another study found that it increased antibody levels by 10.2 to 16.5 times in older adults, aiding the body's defense against the virus. This vaccine has been shown to reduce the risk of severe RSV-related illnesses, making it a strong choice for older adults seeking protection. ^{6 7 8 9 10}

Who Is on the Research Team?

Nadine Rouphael, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older to study immune responses to the Moderna RSV vaccine. Specific eligibility details are not provided, but typically participants must be in good health and meet certain medical criteria.

Inclusion Criteria

Able and willing to provide written informed consent

Available for all study visits and procedures, including follow-up through Day 180

Willing to allow access to prior RSV vaccination history (if applicable) for eligibility verification

Exclusion Criteria

Any bleeding disorder that poses a risk for venipuncture or vaccination complications

Participation in another clinical trial involving an investigational agent within 30 days of enrollment

History of severe allergic reaction (e.g., anaphylaxis) to any prior vaccines or any component of the MRESVIA vaccine, including polyethylene glycol (PEG), SM-102, or other listed excipients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a single dose of the Moderna RSV vaccine (MRESVIA)

1 day

1 visit (in-person)

Early Follow-up

Participants are monitored for adverse events and antibody responses within 28 days following vaccination

4 weeks

2 visits (in-person)

Extended Follow-up

Participants are monitored for adverse events and antibody responses up to 180 days post-vaccination

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Moderna RSV vaccine

Trial Overview The trial is testing how the FDA-approved Moderna RSV vaccine affects the immune system of older adults using advanced scientific techniques to understand immunity better.

How Is the Trial Designed?

Group I: Moderna RSV vaccine (MRESVIA) Experimental Treatment 1 Intervention

Adults who are ≥60 years of age and are eligible to receive FDA-approved RSV vaccines under standard clinical recommendations receive a single dose of the Moderna RSV vaccine (MRESVIA).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Open Philanthropy

Collaborator

Trials

8

Recruited

6,800+

Citations

1. cdc.gov cdc.gov/rsv/hcp/vaccine-clinical-guidance/adults.html

RSV Vaccine Guidance for Adults In this trial, efficacy of a single dose of mResvia against symptomatic RSV was approximately 80% during the first 4 months following vaccination and ...

2. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf496/8293665

Estimated Vaccine Effectiveness for Respiratory Syncytial ... The RSVpreF vaccine was 92% effective against both RSV-related ARI ED visits/hospitalizations and severe ARI in this older adult real-world ...

3. products.modernatx.com products.modernatx.com/mresviapro/efficacy

Efficacy for mRESVIA® (Respiratory Syncytial Virus Vaccine) The primary efficacy endpoints were the prevention of a first episode of RSV-LRTD with ≥2 or ≥3 signs or symptoms starting 14 days after vaccination. 1|| ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11574772/

Respiratory Syncytial Virus Vaccine (mRNA) - PMC In a phase 1 trial in healthy older adults 65 to 79 years of age, RSV neutralizing antibody titers were increased 10.2- to 16.5-fold against RSV ...

5. cidrap.umn.edu cidrap.umn.edu/respiratory-syncytial-virus-rsv/rsv-vaccines-estimated-be-58-83-protective-older-adults

RSV vaccines estimated to be 58% to 83% protective in ... "Phase 3 trials of RSVpreF vaccines against RSV-related lower respiratory tract disease have shown vaccine efficacy levels of 88.9%, 82.6%, and ...

6. products.modernatx.com products.modernatx.com/mresviapro/safety

Safety Profile for mRESVIA® (Respiratory Syncytial Virus ... Well tolerated in adults aged 60 or older 1, as well as in adults aged 18 to 59 who are at increased risk for LRTD caused by RSV. In both a placebo-controlled, ...

7. cdc.gov cdc.gov/vaccine-safety/vaccines/rsv.html

Respiratory Syncytial Virus (RSV) Vaccine Safety FDA licensed the Moderna RSV vaccine (mResvia) in May 2024. ... RSV vaccine for pregnant women are consistent with clinical trial safety data.

8. medicomart.com medicomart.com/images/document/RSV%20SDS%20sheet.pdf

Safety Data Sheet Moderna Therapeutics - Respiratory Syncytial Virus (RSV) vaccine. Revision date:18 January 2024, Version:2.1. Safety Data Sheet. SECTION 1: Identification.

9. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-MRESVIA_1.pdf

Package Insert - MRESVIA The safety of MRESVIA was evaluated in Study 2 (NCT06067230) in which 502 participants aged 18 through 59 years at increased risk for LRTD caused by RSV ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12392792/

Post-marketing safety monitoring of RSV vaccines: A real ... In Phase III clinical trials, a single dose of RSVpreF (Abrysvo, Pfizer) showed an efficacy of 88.9% in preventing symptomatic LRTI, while ...