RSV Vaccine for Respiratory Syncytial Virus

(MONET Trial)

Recruiting at 44 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Immunosuppressants, Corticosteroids, Blood products

Disqualifiers: Immunocompromised, Metastatic malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months for Substudy A, 7 months for Substudy B

886 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine to see if it is safe and effective in adults who are at high risk of severe RSV illness. The study includes adults with chronic conditions and those with weakened immune systems. The vaccine helps the body make antibodies to fight the virus.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain treatments like high-dose systemic corticosteroids or have received blood products recently, you may not be eligible. It's best to discuss your specific medications with the study team.

How is the RSVpreF vaccine different from other RSV treatments?

The RSVpreF vaccine is unique because it is designed to protect both infants and older adults from RSV by targeting the prefusion F protein of the virus, which is crucial for its ability to infect cells. It is approved for use in pregnant individuals to help protect their infants and is also approved for older adults, making it a versatile option for preventing RSV-related illnesses. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults at high risk of severe RSV disease, aged 18-60 with chronic health issues like lung or heart conditions, but not those who are immunocompromised. It's also for adults over 18, including those over 60 with weakened immune systems. Participants must be able to consent and commit to the study schedule.

Inclusion Criteria

My condition has been stable without major treatment changes or hospital visits for worsening symptoms in the last 3 months.

I've needed regular doctor visits or medication, or was hospitalized in the last year.

I am willing and able to follow the study's schedule and requirements.

Exclusion Criteria

I do not have enough muscle in my upper arm for shots.

I have never received an RSV vaccine and don't plan to during the study.

I haven't received any RSV monoclonal antibodies in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RSVpreF or placebo (Substudy A) or RSVpreF (Substudy B) with blood samples taken at each visit

6 months for Substudy A, 7 months for Substudy B

3 visits (Substudy A), 4 visits (Substudy B)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month after last dose

Treatment Details

Interventions

• RSVpreF

Trial Overview The trial tests a vaccine called RSVpreF against a placebo in one group and gives two doses of the vaccine to another group with weakened immune systems. The goal is to see how well participants' bodies produce antibodies against Respiratory Syncytial Virus after vaccination.

Participant Groups

Group I: Substudy B - RSVpreF Experimental Treatment 1 Intervention

Participants will receive 120-µg doses of RSVpreF at Visit 1 and Visit 2 (open label, single arm only)

Group II: Substudy A - RSVpreF Experimental Treatment 1 Intervention

Participants will receive a single 120-µg dose of RSVpreF at Visit 1

Group III: Substudy A - Placebo Placebo Group 1 Intervention

Participants will receive placebo at Visit 1

RSVpreF is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Abrysvo for:

• Lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older
• LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age

Approved in European Union as Abrysvo for:

• LRTD caused by RSV in adults 60 years of age and older
• LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age

Approved in Canada as Abrysvo for:

• LRTD caused by RSV in adults 60 years of age and older
• LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age

Approved in Japan as Abrysvo for:

• LRTD caused by RSV in adults 60 years of age and older
• LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Pfizer's bivalent RSV vaccine, RSVpreF, has been approved in the USA for use in pregnant individuals to protect infants from respiratory syncytial virus (RSV) illness, as well as for individuals aged 60 and older to prevent lower respiratory tract disease caused by RSV.

The vaccine has also received approval in the EU for both indications and is currently under review for regulatory approval in Canada and Japan, highlighting its potential global impact in preventing RSV-related illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Syncytial Virus Prefusion F Subunit Vaccine: First Approval of a Maternal Vaccine to Protect Infants. Syed, YY.[2023]

The bivalent RSVpreF vaccine was found to be safe and well-tolerated in a study of 618 adults aged 18-49, with mostly mild or moderate local and systemic reactions and no serious adverse events reported within 12 months post-vaccination.

The vaccine induced strong virus-neutralizing responses, with antibody levels significantly higher than those needed for protection in high-risk infants, suggesting its potential effectiveness for maternal immunization against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. Walsh, EE., Falsey, AR., Scott, DA., et al.[2022]

The RSVpreF vaccine candidate was found to be safe and well-tolerated in older adults (ages 65-85), eliciting strong and lasting immune responses against the respiratory syncytial virus, regardless of the formulation used.

Adding the adjuvant CpG/Al(OH)3 did not enhance the immune response compared to the standard aluminum hydroxide adjuvant, and most side effects were mild, indicating that the vaccine is a promising option for protecting older adults from RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. Baber, J., Arya, M., Moodley, Y., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Respiratory Syncytial Virus Prefusion F Subunit Vaccine: First Approval of a Maternal Vaccine to Protect Infants. [2023]

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

A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. [2022]

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

A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. [2023]

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

Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. [2023]

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

Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. [2023]