RSVpreF Vaccine for Bronchitis

(RENOIR Trial)

Not currently recruiting at 387 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

Disqualifiers: Metastatic malignancy, End-stage renal disease, Unstable cardiac disease, Immunodeficiency, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine called RSVpreF to evaluate its effectiveness in preventing bronchitis caused by the RSV virus in older adults. The study assesses the vaccine's safety and duration of effectiveness, with some participants receiving a second dose at varying times to determine the optimal schedule. The trial seeks adults aged 60 or older who live independently or with minimal assistance and can manage daily tasks. Participants should be generally healthy, even if they have stable conditions like asthma or COPD. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking vaccine.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic systemic immunosuppressive therapy, you may need to stop it 60 days before the study intervention. Inhaled, nebulized, or topical corticosteroids are allowed if they do not exceed a dose equivalent to 10 mg/day of prednisone for COPD or asthma. Please consult with the study team for specific guidance.

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

Research has shown that the RSVpreF vaccine has been tested for safety in older adults. A review of studies involving individuals aged 60 and older found that the vaccine was generally well-tolerated. The most common side effects were mild, such as pain at the injection site, tiredness, and headache, while serious side effects were rare.

Additionally, studies in pregnant individuals reported similar side effects to those observed in earlier research, indicating a consistent safety record. This demonstrates that the vaccine has been tested in many people and is generally considered safe.

In this trial, participants will receive a 120µg dose of RSVpreF, which has been studied previously. As a Phase 3 trial, the vaccine has already undergone earlier testing stages and is deemed safe enough for a larger group of people. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for bronchitis?

Researchers are excited about the RSVpreF vaccine for bronchitis because it targets the RSV (respiratory syncytial virus) protein, which is a novel approach compared to traditional treatments like bronchodilators or corticosteroids that focus on symptom relief. Unlike current options that mainly manage symptoms, RSVpreF aims to prevent the infection in the first place by boosting the immune response specifically against RSV. This vaccine could provide long-lasting protection and reduce the overall burden of bronchitis caused by RSV, offering a proactive solution rather than a reactive one.

What evidence suggests that the RSVpreF vaccine could be an effective treatment for bronchitis?

Research has shown that the RSVpreF vaccine, which participants in this trial may receive, effectively prevents serious lung infections caused by RSV in people aged 60 and older. Studies found it to be 89% effective in stopping RSV-related lung issues requiring hospital or emergency care. The vaccine also proved about 80% effective in preventing RSV symptoms within the first four months after administration. This is important because vaccines like RSVpreF, based on the prefusion F protein, have great potential to lessen RSV's impact in older adults. Overall, the evidence supports RSVpreF as a promising way to protect older adults from severe RSV-related illnesses. ^{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?

Adults aged 60 and older who can consent to the study, are generally healthy or have stable chronic disease, live independently or with minimal assistance, and agree to use contraception if applicable. Excluded are those on immunosuppressive therapy, with bleeding disorders, severe vaccine allergies, recent blood product receipt, prior RSV vaccination or participation in other drug trials.

Inclusion Criteria

Participants who received RSVpreF in the efficacy study

Participants who have a Visit 2 serology sample available for testing from the efficacy study, completed the end-of-Season 2 visit (Visit 5), and did not meet exclusion criteria throughout the efficacy study duration

I am a man who can father children and agree to use effective birth control during and after the study.

Exclusion Criteria

Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination

I have not received blood products or immunoglobulin in the last 60 days.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RSVpreF vaccine or placebo

24 months

Multiple visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Substudy A

Evaluation of safety and immunogenicity of a second dose of RSVpreF after 2 years

18 months

Blood samples collected for antibody testing

Substudy B

Evaluation of safety and immunogenicity of a second dose of RSVpreF after 1 year

18 months

Blood samples collected for antibody testing

Substudy C

Evaluation of safety and immunogenicity of a second dose of RSVpreF after 3 or 4 years

18 months

Blood samples collected for antibody testing

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RSVpreF

Trial Overview The trial is testing a single dose of RSVpreF against placebo for preventing lung infections caused by RSV in older adults. It includes two substudies: one assessing safety after a second dose at 2 years and another at 1 year post-initial dose. Participants will be monitored for up to 24 months.

How Is the Trial Designed?

Group I: SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination) Experimental Treatment 1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at the Year 3 vaccination followed by RSVpreF at the Year 4 vaccination in SSC.

Group II: SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination) Experimental Treatment 1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive RSVpreF at the Year 3 vaccination followed by placebo at the Year 4 vaccination in SSC.

Group III: SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination) Experimental Treatment 1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive RSVpreF in SSB.

Group IV: SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination) Experimental Treatment 1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive RSVpreF in SSA.

Group V: Efficacy Study: RSVpreF vaccine Experimental Treatment 1 Intervention

RSVpreF

Group VI: SSC: Vaccination of RSVpreF recipients with Placebo Placebo Group 1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at both the Year 3 and Year 4 vaccination in SSC.

Group VII: SSB: Vaccination of RSVpreF recipients with Placebo Placebo Group 1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive Placebo in SSB.

Group VIII: Efficacy Study: Placebo dose Placebo Group 1 Intervention

Placebo

Group IX: SSA: Vaccination of RSVpreF recipients with Placebo Placebo Group 1 Intervention

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive Placebo in SSA.

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 RSVPreF3 vaccine combined with the AS01 adjuvant significantly boosted RSV-neutralizing antibody responses and T cell responses in both mice and cattle, indicating its potential effectiveness for older adults.

In both animal models, the RSVPreF3/AS01 formulation outperformed non-adjuvanted versions in generating stronger immune responses, suggesting it is a promising candidate for further clinical evaluation as a vaccine for RSV in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. Bouzya, B., Rouxel, RN., Sacconnay, L., et al.[2023]

The study involving 48 young adults and 1005 older adults demonstrated that the RSVPreF3 vaccine significantly boosted immune responses, particularly after the first dose, with higher levels of RSV-specific antibodies and T cells observed in participants receiving the AS01-adjuvanted formulation.

Safety assessments revealed that most side effects were mild to moderate and temporary, with no significant safety concerns identified, leading to the selection of the AS01E-adjuvanted vaccine for further clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial. Leroux-Roels, I., Davis, MG., Steenackers, K., et al.[2023]

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 Ad26.RSV.preF vaccine, tested in a phase 1/2a study with 352 adults aged 60 and older, was found to be well tolerated, showing similar side effects across different regimens.

Combining Ad26.RSV.preF with RSV preF protein significantly enhanced humoral immune responses while maintaining cellular responses, suggesting this combination could be more effective in generating immunity against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. Comeaux, CA., Bart, S., Bastian, AR., et al.[2023]

The Ad26.RSV.preF vaccine candidate showed good safety and immunogenicity in a study involving 12 adults and 36 RSV-seropositive children, with no serious adverse events reported and only mild to moderate reactions observed.

The vaccine significantly increased RSV neutralization titers in children and resulted in fewer RSV infections compared to the placebo group, indicating its potential effectiveness in preventing RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. Stuart, ASV., Virta, M., Williams, K., et al.[2023]

The investigational bivalent prefusion F vaccine (RSVpreF) was well tolerated in healthy adults aged 18-85, with mostly mild to moderate side effects, indicating a favorable safety profile.

RSVpreF elicited strong immune responses in older adults, significantly increasing serum-neutralizing antibodies against RSV, suggesting it could effectively protect this vulnerable population from RSV disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. Falsey, AR., Walsh, EE., Scott, DA., et al.[2022]

The novel intranasal vaccine SynGEM was found to be safe and well-tolerated in a phase I trial involving 48 healthy volunteers, with no significant adverse events reported compared to the placebo group.

SynGEM successfully induced durable RSV-specific antibody responses, particularly in high-dose recipients, demonstrating its potential as the first nonreplicating intranasal subunit vaccine for respiratory syncytial virus (RSV).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local and Systemic Immunity against Respiratory Syncytial Virus Induced by a Novel Intranasal Vaccine. A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Ascough, S., Vlachantoni, I., Kalyan, M., et al.[2022]

Citations

1. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.002/7986823

165. Real-world Abrysvo Vaccine Effectiveness (VE) against ... Abrysvo's pivotal trial analysis of efficacy against severe RSV-related respiratory disease was hampered by accrual of few hospitalizations/ED events.

2. 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 ...

3. 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11645642/

Estimated Vaccine Effectiveness for Respiratory Syncytial ... These findings suggest that during the 2023 to 2024 RSV season, RSVpreF substantially reduced severe medically attended RSV disease in an older ...

5. nature.com nature.com/articles/s41591-024-03431-7

Impact of RSVpreF vaccination on reducing the burden ... Prefusion F protein-based vaccines have shown high efficacy against RSV disease in clinical trials, offering promise for mitigating this burden.

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. 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.

9. fda.gov fda.gov/media/168889/download

Package Insert - ABRYSVO (STN 125769) Human Data. In Study 1, 3,698 pregnant individuals received ABRYSVO and 3,687 received placebo at 24 through. 36 weeks' gestation. The infant safety population ...

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

Pfizer RSVpreF Vaccine (ABRYSVO) | ACIP A systematic review of evidence on the efficacy and safety of Pfizer RSVpreF vaccine among persons aged 60 years and older was conducted.