RSV Vaccine for Respiratory Syncytial Virus

(MONET Trial)

No longer recruiting at 46 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, RSVpreF, to evaluate its effectiveness in helping the body combat the Respiratory Syncytial Virus (RSV), which can cause serious lung problems. The study consists of two parts: one for adults with certain long-term health conditions like asthma or heart disease, and another for those with weakened immune systems. Participants will receive the vaccine and undergo blood tests to measure their immune response. Individuals with serious lung issues or immune system concerns might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the RSVpreF vaccine, also known as ABRYSVO, is safe. Studies have found that this vaccine helps lower the risk of serious RSV-related illnesses in adults. It has also been safely used in pregnant women, with side effects similar to those observed in earlier studies.

For those considering joining the trial, this indicates that the vaccine is generally well-tolerated. Common side effects might include mild reactions at the injection site or feeling slightly unwell, but serious side effects are rare. Notably, the FDA has already approved RSVpreF for certain uses, which enhances confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for RSV?

Researchers are excited about RSVpreF for respiratory syncytial virus (RSV) because it targets the virus using a stabilized pre-fusion form of the RSV F protein, a crucial part of the virus's structure. This is different from current RSV preventative options like palivizumab, which is a monoclonal antibody primarily used in high-risk infants. RSVpreF offers a potentially broader application as a vaccine and could provide long-lasting immunity with just one or two doses. Moreover, if successful, this vaccine could be a game-changer in preventing RSV infections more widely across different age groups, including older adults.

What evidence suggests that this trial's RSVpreF vaccine could be effective for preventing severe RSV disease?

This trial will evaluate the RSVpreF vaccine for its effectiveness in preventing severe illness caused by the Respiratory Syncytial Virus (RSV). Participants in Substudy A will receive a single 120-µg dose of RSVpreF or a placebo. In Substudy B, participants will receive 120-µg doses of RSVpreF at two visits. Studies have shown that the RSVpreF vaccine is highly effective. Specifically, research indicates that for adults aged 60 and older, the vaccine's effectiveness against serious RSV-related lung infections ranges from 83% to 89%. This significantly lowers the risk of severe RSV illness that might require hospitalization or an emergency room visit. While most data comes from older adults, these findings strongly suggest that the vaccine can protect vulnerable groups from RSV. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention(s) or any related vaccine

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2828028

Estimated Vaccine Effectiveness for Respiratory Syncytial ...

In our primary analysis, RSVpreF effectiveness was 89% against RSV-related LRTD requiring hospitalization or ED visit among adults aged 60 years ...

2.

cdc.gov

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

RSV Vaccine Guidance for Adults

Real-world effectiveness of Abrysvo cannot yet be estimated during the second year following vaccination. However, clinical trial data showed durable protection ...

3.

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39671195/

Estimated Vaccine Effectiveness for Respiratory Syncytial ...

RSVpreF vaccination conferred protection against RSV-related LRTD in the hospital and ED settings among US adults aged 60 years or older.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352396425004050

Respiratory syncytial virus (RSV) vaccine effectiveness and ...

Vaccine efficacy estimates from the randomised clinical trials for these vaccines was 62.1% (ABRYSVO) and (AREXVY) 71.7%, for adults 60 and older against RSV- ...

6.

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.

7.

abrysvomaternal.pfizerpro.com

abrysvomaternal.pfizerpro.com/about-abrysvo/safety

Safety Profile for ABRYSVO® (Respiratory Syncytial Virus ...

See the safety profile for ABRYSVO, an RSV vaccine to help prevent RSV in infants from birth through 6 months, given to pregnant women at 32 to 36 weeks ...

8.

cdc.gov

cdc.gov/acip/grade/Pfizer-Bivalent-RSVpreF-adults.html

Pfizer RSVpreF Vaccine (ABRYSVO) | ACIP

Pfizer RSVpreF also reduced the risk of medically attended RSV LRTI (vaccine efficacy: 81.0% (95% CI: 43.5%, 95.2%) (Table 3b). The trial was ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11973799/

Safety surveillance of respiratory syncytial virus (RSV) ...

The AEs reported to VAERS among pregnant individuals vaccinated with RSVpreF largely aligned with the safety profile observed in prelicensure studies.

10.

fda.gov

fda.gov/vaccines-blood-biologics/abrysvo

Abrysvo

Active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused ...