mRNA Vaccine for Respiratory Syncytial Virus

Recruiting at 55 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

346 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine called mRNA-1345 to protect young children and high-risk older children from RSV. The vaccine works by teaching the immune system to recognize and fight the virus. mRNA-1345 is among the most promising RSV vaccines, leveraging the success of mRNA technology seen in COVID-19 vaccines.

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.

What data supports the effectiveness of the mRNA-1345 treatment for Respiratory Syncytial Virus?

Research shows that mRNA-based vaccines targeting the RSV F protein, like mRNA-1345, have been effective in increasing protective antibodies in older adults, which are important for fighting RSV infections. ^{1 2 3 4 5}

Is the mRNA vaccine for RSV generally safe for humans?

Research on mRNA COVID-19 vaccines, which are similar in technology to the mRNA RSV vaccine, shows they are generally safe. Some people experienced mild side effects like chills and fatigue, and there were rare cases of heart inflammation, mostly in young males. Overall, the risk of serious side effects is low compared to the benefits of vaccination. ^{6 7 8 9 10}

How is the mRNA-1345 vaccine for RSV different from other treatments?

The mRNA-1345 vaccine for RSV is unique because it uses mRNA technology, which instructs cells to produce a protein that triggers an immune response, unlike traditional vaccines that often use weakened or inactivated viruses. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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 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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. [2023]

2. United States 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. [2023]

3. Netherlands 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. [2023]

4. United States 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Maternal and Child Outcomes Reported by Breastfeeding Women Following Messenger RNA COVID-19 Vaccination. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Disentangling a Thorny Issue: Myocarditis and Pericarditis Post COVID-19 and Following mRNA COVID-19 Vaccines. [2022]

8. Switzerland 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. [2023]

9. United States 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. [2022]

11. China pubmed.ncbi.nlm.nih.gov

Apneic oxygenation with low-flow oxygen cannula for rapid sequence induction and intubation in pediatric patients: a randomized-controlled trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Prehospital rapid sequence intubation in an emergency medical services system with two advanced life support providers. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Rapid-sequence intubation of the pediatric patient. Pediatric Emergency Medicine Committee of the American College of Emergency Physicians. [2019]

14. India pubmed.ncbi.nlm.nih.gov

Use of modified rapid sequence tracheal intubation in pediatric patients. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Rapid sequence intubation in Scottish urban emergency departments. [2022]