RSVpreF Vaccine for Bronchitis

(RENOIR Trial)

Recruiting at 338 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

45000 Participants Needed

Trial Summary

What is the purpose of this trial?

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Canada.

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.

What data supports the idea that RSVpreF Vaccine for Bronchitis is an effective treatment?

The available research shows that the RSVpreF vaccine, also known as Abrysvo, has been approved for use in older adults and pregnant individuals to prevent RSV-related illnesses. In animal studies, the vaccine boosted immune responses that help fight RSV. In humans, it has shown promising results in generating strong immune responses, especially in older adults. This suggests that the RSVpreF vaccine is effective in preventing illnesses caused by RSV, which can lead to conditions like bronchitis. ^{1 2 3 4 5}

What safety data exists for the RSVpreF vaccine?

The RSVpreF vaccine, also known as ABRYSVO, has been approved in the USA and EU for preventing RSV illness in infants and individuals aged ≥ 60 years. Safety data from various studies indicate that the vaccine has been tested in different populations, including pregnant individuals, older adults, and children. Clinical trials have shown that the vaccine is generally well-tolerated, with no significant differences in adverse events compared to placebo groups. The vaccine has been evaluated for safety and immunogenicity in several phase 1/2 trials, demonstrating its ability to induce immune responses without major safety concerns. ^{2 4 5 6 7}

Is the RSVpreF drug a promising treatment for bronchitis?

Yes, RSVpreF is a promising drug for bronchitis as it has been approved for preventing RSV-related illnesses in older adults and infants, showing strong immune responses and safety in trials. ^{1 2 3 4 6}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2023]

4. United States 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. [2022]

5. United States 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. [2022]

6. United States 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. [2023]

7. United States 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. [2023]