RSVpreF + Shingles Vaccine for Respiratory Syncytial Virus

(PISSARRO Trial)

No longer recruiting at 30 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of administering two vaccines—one for Respiratory Syncytial Virus (RSV) and one for shingles—either simultaneously or sequentially. The researchers aim to assess how well the vaccines work together and how the body responds. Participants should be 50 or older and either healthy or with stable long-term health conditions. Those who have had shingles recently or have certain serious health issues may not be eligible. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important vaccine research.

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

Research has shown that the RSVpreF vaccine is generally well-tolerated by healthy adults aged 18-85. Most side effects are mild to moderate, causing some discomfort but usually not serious.

For the HZ/su vaccine, studies indicate that administering it with other vaccines does not significantly affect its safety. It is safe to receive both vaccines simultaneously. Specifically, research found that taking these vaccines together does not alter the side effects, which remain similar whether taken alone or with others.

Overall, this suggests that both RSVpreF and HZ/su vaccines have a good safety record in adults. Mild to moderate side effects are common, as with most vaccines. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the RSVpreF and Shingles vaccine combination because it aims to tackle two conditions simultaneously: respiratory syncytial virus (RSV) and shingles. Unlike standard RSV vaccines, RSVpreF targets the F protein of the virus in its prefusion conformation, which is crucial for preventing infection. This approach may offer more robust protection. Additionally, combining it with the shingles vaccine, HZ/su, could simplify vaccination schedules and improve convenience without compromising efficacy. The potential to address both respiratory infections and shingles with a coadministration strategy is what sets this treatment apart from existing options.

What evidence suggests that this trial's treatments could be effective for RSV and shingles?

This trial will compare two administration strategies for the RSVpreF and HZ/su vaccines. Studies have shown that the RSVpreF vaccine is highly effective against respiratory syncytial virus (RSV) infections. It prevents 92% of RSV-related illnesses requiring emergency visits and 89% of serious lung infections needing hospital care. Additionally, the vaccine reduces RSV-related hospital stays by 83%. The HZ/su vaccine, which prevents shingles, has also shown promise. Research suggests it may lower the risk of developing dementia by 18% to 37% compared to other vaccines, though the exact reasons remain unclear. Together, these vaccines provide strong protection against their target conditions. Participants in this trial will receive either coadministration or sequential administration of these vaccines. ^{1 6 7 8 9}

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

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]

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 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]

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 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]

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]

Citations

1. cidrap.umn.edu cidrap.umn.edu/respiratory-syncytial-virus-rsv/shingles-rsv-vaccines-may-protect-older-adults-dementia

Shingles, RSV vaccines may protect older adults from ... Compared with flu vaccine recipients, those given the RSV or shingles vaccine had 18% to 37% lower odds of receiving a dementia diagnosis in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12198376/

Lower risk of dementia with AS01-adjuvanted vaccination ... AS01-adjuvanted shingles (herpes zoster) vaccination is associated with a lower risk of dementia, but the underlying mechanisms are unclear.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06890416

NCT06890416 | A Study to Evaluate the Safety and ... This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and ...

4. jwatch.org jwatch.org/na59204/2025/10/08/rsvpref-vaccines-effects-severe-outcomes-rsv-infection

RSVpreF Vaccine's Effects on Severe Outcomes of RSV ... The vaccine was 83% effective at preventing hospitalization with RSV-associated respiratory disease and 16% effective against hospitalization ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833776

Respiratory Syncytial Virus Vaccine for US Adults Aged 60 ... In this case-control study of 787 822 patients tested for RSV, vaccine effectiveness was approximately 75% among adults aged 60 years or older.

6. cdc.gov cdc.gov/vaccines/vpd/rsv/hcp/older-adults.html

RSV Vaccination for Adults 60 Years of Age and Over Coadministration of RSV vaccines with other adult vaccines during the same visit is acceptable. Available data on immunogenicity of coadministration of RSV ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24001944

Co-administration of the adjuvanted recombinant zoster ... Co-administration of RZV with routine vaccines does not significantly alter the reactogenicity, immunogenicity or safety of RZV or the co-administered vaccine.

8. us.gsk.com us.gsk.com/media/mizd234m/arexvy-shingrix-us-press-release-data-final-91824.pdf

Press Release GSK announces positive topline data on co-administration of AREXVY and SHINGRIX. • Trial met primary endpoint, non-inferior immune response ...

9. fredhutch.org fredhutch.org/content/dam/www/clinical-pdf/virus-response-tools/rsv-provider-faq.pdf

RSV Vaccines Provider Fact Sheet & FAQs RSV vaccination is currently recommended as a one-time dose. Those who have already received RSV vaccination are NOT recommended to receive ...