RSVpreF + Shingles Vaccine for Respiratory Syncytial Virus

(PISSARRO Trial)

Recruiting at 28 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, others

Disqualifiers: Guillain Barré, Metastatic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 3

526 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.

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 immunosuppressive therapy or certain other treatments, you may not be eligible to participate.

Is the Shingrix vaccine safe for humans?

The Shingrix vaccine, used to prevent shingles, has been shown to be generally safe in humans. Most people experience mild reactions like pain or redness at the injection site, and serious side effects are rare. ^{1 2 3 4 5}

How is the RSVpreF + Shingles Vaccine different from other treatments for RSV?

The RSVpreF + Shingles Vaccine is unique because it combines protection against both respiratory syncytial virus (RSV) and shingles in one vaccine, using a non-replicating chimpanzee adenovirus vector to induce strong immune responses. This dual approach is novel compared to existing treatments that typically target only one of these conditions separately. ^{6 7 8 9 10}

What data supports the effectiveness of the RSVpreF + Shingles Vaccine treatment for Respiratory Syncytial Virus?

The RSVpreF component of the treatment has shown to induce strong immune responses against RSV in various studies, including one where it demonstrated protective efficacy in animal models. Additionally, the shingles vaccine component is known to be highly effective in inducing immune responses against the virus that causes shingles. ^{7 8 9 10 11}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults aged 50 and older can join this study to test the safety and immune response of two vaccines given together: one for shingles (Herpes Zoster) and another for Respiratory Syncytial Virus (RSV).

Inclusion Criteria

I am 50 or older and either healthy or have stable chronic conditions.

Exclusion Criteria

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

I have not had the Zostavax vaccine in the last 2 years.

I currently have or had shingles within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive RSVpreF and HZ/su vaccines according to their assigned group

2 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination

4 months

What Are the Treatments Tested in This Trial?

Interventions

• HZ/su
• RSVpreF

Trial Overview The trial is testing RSVpreF, a vaccine aimed at preventing RSV, alongside HZ/su, a shingles vaccine. Participants will receive both vaccines to see how well they work when administered at the same time.

How Is the Trial Designed?

Group I: Sequential Administration Group Experimental Treatment 2 Interventions

* Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2

Group II: Coadministration Group Experimental Treatment 2 Interventions

* Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2

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 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 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 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 herpes zoster subunit vaccine (HZ/su) is highly effective, reducing the risk of developing shingles by over 90% compared to a placebo, making it a strong preventive measure for adults aged 50 and older.

The vaccine has a comparable safety profile to other vaccines, with common side effects including injection site pain and mild systemic reactions like fatigue and headache, supporting its routine use as recommended by the Advisory Committee on Immunization Practices (ACIP).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine. James, SF., Chahine, EB., Sucher, AJ., et al.[2019]

The recombinant zoster vaccine (RZV; Shingrix) is effective and recommended for adults aged 50 and older, showing a safety profile consistent with prelicensure trials, where serious adverse events were similar to placebo rates.

In the first 8 months post-licensure, out of 3.2 million doses distributed, 4,381 adverse event reports were received, with common reactions being fever and injection site pain, but no unexpected safety concerns were identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. Hesse, EM., Shimabukuro, TT., Su, JR., et al.[2020]

HZ/Su, also known as 'Shingrix', is a new subunit vaccine designed to prevent shingles, particularly important for aging populations who are at higher risk.

Unlike the older live attenuated shingles vaccine, HZ/Su is suitable for a broader range of individuals, addressing safety concerns and potential long-term effectiveness issues associated with the previous vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Bharucha, T., Ming, D., Breuer, J.[2021]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Pre-Clinical Development of an Adenovirus Vector Based RSV and Shingles Vaccine Candidate. [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

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]

4. 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]

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

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

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

Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine. [2019]

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

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) - United States, October 2017-June 2018. [2020]

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

Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. [2022]

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

A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. [2021]

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

Safety and immunogenicity of adjuvanted recombinant subunit herpes zoster vaccine in lung transplant recipients. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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