mRNA Vaccine for Respiratory Syncytial Virus

No longer recruiting at 57 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, RSV antibodies

Disqualifiers: Acute illness, Recent vaccines, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mRNA vaccine to determine its safety and effectiveness against respiratory syncytial virus (RSV), which can cause serious lung infections, particularly in young children. Part A involves two groups: children aged 2 to under 5, and children aged 5 to under 18 with conditions that increase the severity of RSV. Part B tracks RSV cases and monitors vaccine safety over the next season for those who participated in Part A. Children with stable health conditions who are more susceptible to RSV may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important vaccine development.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have received any systemic immunosuppressants recently, except for short courses of oral corticosteroids completed at least 3 months before joining the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that mRNA-1345 is a vaccine designed to protect against Respiratory Syncytial Virus (RSV). Although specific data for mRNA-1345 is not yet available, similar vaccines, like mRESVIA, have been tested in other studies. These studies have found that mRESVIA is generally safe for adults aged 18 to 59 who are at higher risk for severe RSV.

Participants in these studies often experienced common reactions, such as soreness at the injection site and mild flu-like symptoms. These side effects were usually brief and not serious. Since mRNA-1345 is similar, it might have a comparable safety profile. However, mRNA-1345 is still under investigation, and this new trial will provide more information about its safety, especially in children and those at high risk for RSV. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional vaccines for Respiratory Syncytial Virus (RSV), which often use inactivated virus or viral protein subunits, mRNA-1345 employs cutting-edge mRNA technology. This approach involves using synthetic mRNA to instruct cells to produce a protein that triggers an immune response, potentially offering a more robust and quicker protective effect. Researchers are particularly excited about mRNA-1345 because it can be rapidly developed and adapted, which is a significant advantage in responding to viral mutations. Additionally, the ability to deliver this vaccine as a single intramuscular injection simplifies the vaccination process, enhancing accessibility and compliance.

What evidence suggests that mRNA-1345 might be an effective treatment for RSV?

A study found the mRNA-1345 vaccine to be very effective in protecting older adults from RSV, a virus that affects the lungs, reducing the risk of serious lung problems by about 84%. The vaccine also showed no major safety concerns. Another study demonstrated that one dose of the vaccine was about 80% effective in preventing RSV symptoms for the first four months after administration. In this trial, participants aged 2 to <5 years and 5 to <18 years will receive the mRNA-1345 vaccine to evaluate its effectiveness and safety in these age groups. These findings suggest that mRNA-1345 could help protect against RSV, making it a promising option for children and people at high risk. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children aged 2 to less than 18 years who are at high risk of RSV disease. It includes healthy kids or those with stable chronic conditions that increase RSV risk. Girls able to have babies must test negative for pregnancy, use birth control, and not be breastfeeding.

Inclusion Criteria

You are classified as either healthy or have a stable chronic condition that increases the risk of RSV disease, based on the clinical judgment of the Investigator.

I have a stable chronic condition that increases my risk for RSV disease.

I am not pregnant, not breastfeeding, and have used birth control or abstained for 28 days.

Exclusion Criteria

I have not been feverish or severely ill in the last 3 days.

History of a diagnosis or condition that, in the judgment of the Investigator, may affect study assessment or compromise participant safety.

I have not received and do not plan to receive any vaccines 14 days before or after the study vaccine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of mRNA-1345 or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with seroresponse measured at Day 29 and Month 6

6 months

Safety Follow-up (Part B)

Participants have the option to be re-enrolled into a 6-month safety follow-up period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1345

Trial Overview The study tests mRNA-1345, an experimental vaccine against Respiratory Syncytial Virus (RSV), compared to a placebo. The goal is to check the vaccine's safety and immune response in young participants to decide on doses for future trials.

How Is the Trial Designed?

Group I: Part A: Cohort 2 (5 to <18 Years of Age) Experimental Treatment 1 Intervention

Participants 5 to \<18 years of age will receive a single IM injection of mRNA-1345 on Day 1.

Group II: Part A and Part B: Cohort 1 (2 to <5 Years of Age) Experimental Treatment 2 Interventions

Part A: Participants 2 to \<5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1. Part B: Participants will have the option to be re-enrolled into a 6-month safety-follow up period.

mRNA-1345 is already approved in United States for the following indications:

Approved in United States as mRESVIA for:

• Prevention of lower respiratory tract disease caused by RSV infection in adults aged 60 years and older

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

A comparative safety study involving 18,755 individuals vaccinated with mRNA COVID-19 vaccines and 27,895 individuals vaccinated with influenza vaccines found that mRNA vaccines had a different safety profile, with more systemic reactions like chills and fatigue compared to the influenza vaccine.

While mRNA COVID-19 vaccines showed a higher risk for some manageable cardiovascular issues, such as hypertensive crisis and supraventricular tachycardia, they had a lower risk of serious neurological complications compared to influenza vaccines, indicating a generally favorable safety profile for mRNA vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. Kim, MS., Jung, SY., Ahn, JG., et al.[2022]

The RSVPreF3 vaccine candidate was found to be safe for use in 213 healthy pregnant women, with no significant adverse events related to the vaccine or placebo reported during the study.

The vaccine effectively increased RSV-specific neutralizing antibody levels in mothers and successfully transferred these antibodies to newborns, indicating strong immunogenicity and potential protection for infants against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. Bebia, Z., Reyes, O., Jeanfreau, R., et al.[2023]

A study analyzing 4838 reports from the European database EudraVigilance found that mRNA COVID-19 vaccines, particularly BNT162b2, have a favorable safety profile in children aged 5-11, with serious adverse events reported in 38.7% of cases, but most were manageable.

The most common side effects included fever, headache, and vomiting, with only 20 cases of Multisystem Inflammatory Syndrome reported, indicating that while monitoring is essential, the benefits of vaccination in this age group outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study. Zinzi, A., Gaio, M., Liguori, V., et al.[2023]

The mRNA-based vaccine V172, designed to target the pre-fusion form of the RSV F glycoprotein, was found to be safe and well-tolerated in a Phase 1 clinical trial involving 112 older adults and 48 younger adults, with common side effects being mild and manageable.

V172 induced higher neutralizing antibody levels compared to a previous vaccine candidate (V171.2) and demonstrated protective effects in an animal model, suggesting it could be an effective option for preventing RSV infections in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults. Nussbaum, J., Cao, X., Railkar, RA., et al.[2023]

The Phase 1 trial of the recombinant RSV F protein nanoparticle vaccine showed it was well-tolerated by healthy adults aged 18-49, with no significant dose-related toxicity or serious adverse events reported.

Immunogenicity results indicated a significant increase in RSV A and B neutralization and anti-F IgG levels, suggesting that the vaccine could potentially reduce the risk of hospitalization due to RSV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. Glenn, GM., Smith, G., Fries, L., et al.[2012]

The mRNA-1345 vaccine demonstrated high efficacy, with 83.7% effectiveness in preventing RSV-associated lower respiratory tract disease with at least two symptoms, and 68.4% efficacy against RSV-associated acute respiratory disease in a study involving 35,541 older adults.

The vaccine was generally safe, with most adverse reactions being mild to moderate and transient, although there was a higher incidence of local and systemic reactions compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. Wilson, E., Goswami, J., Baqui, AH., et al.[2023]

The study found that mRNA COVID-19 vaccines were associated with 1,165 cases of myocarditis and 743 cases of pericarditis, primarily affecting young males after the second dose, but the overall risk is very low at 0.38 cases per 100,000 vaccinated individuals.

Importantly, the risk of myocarditis from mRNA vaccines is significantly lower than the risk of developing myocarditis from a SARS-CoV-2 infection, which ranges from 1000 to 4000 cases per 100,000 people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disentangling a Thorny Issue: Myocarditis and Pericarditis Post COVID-19 and Following mRNA COVID-19 Vaccines. Rafaniello, C., Gaio, M., Zinzi, A., et al.[2022]

In a safety surveillance study of the 2021/22 MF59-adjuvanted quadrivalent influenza vaccine (aQIV) among 1,059 older adults in Italy, only one non-serious adverse event (a case of pyrexia) was reported, resulting in a very low rate of 0.9 per 1,000 doses administered.

The study confirmed that the reactogenicity profile of aQIV is consistent with the established safety profile of the previous trivalent formulation, which may enhance public confidence in influenza vaccination and improve vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced passive safety surveillance of the MF59-adjuvanted quadrivalent influenza vaccine in the elderly during the 2021/22 influenza season. Amicizia, D., Domnich, A., Lai, PL., et al.[2023]

The investigational RSV vaccine ChAd155-RSV was well-tolerated in healthy adults aged 18-45, with no dose-related toxicity or serious adverse events observed during a 1-year follow-up.

ChAd155-RSV effectively increased specific immune responses, including neutralizing antibodies and T-cell activity, indicating its potential efficacy in generating protection against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. Cicconi, P., Jones, C., Sarkar, E., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40610413/

Immune correlates analysis of mRNA-1345 RSV vaccine ... In the pivotal phase 3 trial, the mRNA-1345 vaccine demonstrated efficacy against RSV in older adults (NCT05127434). Here, we evaluate ...

2. vaccineadvisor.com vaccineadvisor.com/news/revaccination-with-mrna-1345-for-rsv-maintains-robust-immunogenicity-and-safety/

Revaccination With mRNA-1345 for RSV Maintains Robust ... Revaccination with mRNA-1345 against RSV at 12 months was noninferior to primary vaccination among adults aged 50 years and older.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307079

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine ... A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease.

4. 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 ...

5. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/mresvia

mResvia | European Medicines Agency (EMA) Around 4 months after vaccination, people who received mResvia had an 84% reduction in their risk of getting lower respiratory tract disease caused by RSV, ...

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

Safety Data Sheet Respiratory Syncytial Virus (RSV) vaccine is an mRNA vaccine against RSV. ... No data available for mRNA-1345. For another chemically ...

7. 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 ...

8. products.modernatx.com products.modernatx.com/mresviapro/safety

Safety Profile for mRESVIA® (Respiratory Syncytial Virus ... Evaluate the safety profile of the mRESVIA RSV vaccine, including reported local and systemic adverse reactions between mRESVIA and a placebo.

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

Respiratory Syncytial Virus (RSV) Vaccine Safety RSV immunizations protect people at increased risk for severe RSV disease when used according to the approved guidelines and recommendations.

10. ema.europa.eu ema.europa.eu/en/documents/product-information/mresvia-epar-product-information_en.pdf

mRESVIA, INN-Respiratory Syncytial Virus mRNA vaccine Safety and immunogenicity data on mRESVIA are not available for immunocompromised individuals. Individuals receiving immunosuppressant therapy or patients ...