RSV Vaccine for Respiratory Syncytial Virus

(PICASSO Trial)

No longer recruiting at 20 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunocompromised, Autoimmune disease, Seizures, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a vaccine called RSVpreF to assess its safety and impact on the immune system in children aged 2 to under 18 years. The goal is to determine the right dose for future trials. Participants will receive a single vaccine shot and attend several follow-up visits. The study suits children who are healthy or have ongoing conditions like cystic fibrosis, asthma, or Down syndrome, which may increase their risk for RSV, a virus affecting breathing. Conducted in the U.S., the trial lasts about six months per participant. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new vaccine.

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 chronic systemic treatment with immunosuppressant medications or have received certain treatments like monoclonal antibodies against RSV recently, 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, in both low and standard doses, has been generally safe in past studies. Safety checks for the low dose included people with weakened immune systems, and no special safety issues emerged. The standard dose, tested in healthy adults and pregnant women, also revealed no major safety risks. In these groups, the vaccine was well-tolerated, with no unusual side effects.

The vaccine is already approved for use in some adults, indicating its safety. However, since this trial involves children, confirming its safety for them is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about RSVpreF because it offers a fresh approach to combatting Respiratory Syncytial Virus (RSV) infections. Unlike traditional treatments, which mainly focus on symptom relief, RSVpreF is a vaccine designed to prevent the virus by targeting the pre-fusion form of the F protein, a critical component for RSV to infect cells. This targeted action not only aims to halt the virus before it can cause illness but also has the potential to provide protection especially for young children and those with chronic high-risk conditions. Additionally, the study explores varying doses, which could offer tailored protection based on age and health status, potentially leading to a more personalized and effective prevention strategy.

What evidence suggests that this trial's RSV vaccine could be effective for preventing respiratory syncytial virus in children?

Studies have shown that the RSVpreF vaccine is promising in combating respiratory syncytial virus (RSV). Research indicates that the low dose is well-tolerated and triggers a strong immune response in adults, suggesting similar effects in children. The standard dose has proven effective in helping the body fight off RSV. In adults, the vaccine has demonstrated up to 87% effectiveness in preventing RSV-related illnesses. Although these results derive from studies in older age groups, they offer hope for its effectiveness in children. This trial will evaluate both low and standard doses of the RSVpreF vaccine in children, aiming to protect against severe RSV symptoms, which is especially important for children with high-risk conditions. ^{5 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?

Children aged 2 to <18 years at high risk of RSV disease can join this trial. They may have conditions like cystic fibrosis, asthma, lung issues, Down syndrome, neuromuscular diseases, cerebral palsy or congenital heart disease. For Phase 1 only: kids 2 to <5 must show prior RSV exposure. Parents/guardians must consent and help with study procedures.

Inclusion Criteria

My parent or guardian can sign the consent form for me.

Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, and other study procedures, including collection of nasal swabs by participants' parent(s)/legal guardian(s) and by study staff when indicated

I am a child at high risk of RSV due to a chronic condition like cystic fibrosis or asthma.

Exclusion Criteria

I have not received any RSV vaccine before or plan to during the study. My child may have been exposed through maternal immunization.

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

I have not been in any drug studies in the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one injection of RSVpreF and are monitored for local and systemic reactions

1 week

1 in-clinic visit, 1 telehealth visit

Follow-up

Participants are monitored for adverse events and immune response

6 months

1 in-clinic visit, 1 telehealth visit

What Are the Treatments Tested in This Trial?

Interventions

• RSVpreF

Trial Overview

The trial is testing a vaccine called RSVpreF for safety and immune response in two phases. Phase 1 determines the dose for later stages; all get one shot of the vaccine. In Phases 2/3, participants are randomly given either the vaccine or a placebo without knowing which they received.

How Is the Trial Designed?

Group I: standard dose in 5 to <18 years olds, healthy Experimental Treatment 1 Intervention

standard dose (120 µg)

Group II: standard dose in 5 to < 18 years olds, with chronic high risk conditions Experimental Treatment 1 Intervention

standard dose (120 µg)

Group III: standard dose in 2 to < 5 years olds Experimental Treatment 1 Intervention

standard dose (120 µg)

Group IV: low dose in 5 to <18 years olds, with chronic high risk conditions Experimental Treatment 1 Intervention

low dose (60 µg)

Group V: low dose in 5 to <18 years olds, healthy Experimental Treatment 1 Intervention

low dose (60 µg)

Group VI: low dose in 2 to < 5 years olds Experimental Treatment 1 Intervention

low dose (60 µg)

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 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 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 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]

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.

pfizer.com

pfizer.com/news/press-release/press-release-detail/pfizer-announces-top-line-results-abrysvor-rsv

Pfizer Announces Top-Line Results of ABRYSVO® for RSV ...

First assessment from an RSV vaccine study in immunocompromised adults show ABRYSVO was well-tolerated and generated strong neutralizing ...

2.

academic.oup.com

academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf061/8006665

Efficacy, Immunogenicity, and Safety of the Bivalent ...

In this phase 3 trial in persons aged ≥60 years, RSVpreF demonstrated vaccine efficacy (VE) of 88.9% and 77.8% against RSV-associated LRTI with ≥3 symptoms at ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2307079

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine ...

Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV ...

4.

cdc.gov

cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm

Use of Respiratory Syncytial Virus Vaccines in Adults Aged ...

This report describes ACIP recommendations for the use of the RSV vaccine for older adults.

5.

pmc.ncbi.nlm.nih.gov

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

Estimated Vaccine Effectiveness for Respiratory Syncytial ...

This case-control study estimates vaccine effectiveness of RSVpreF for RSV-related lower respiratory tract disease hospitalizations and emergency department ...

6.

fda.gov

fda.gov/media/168889/download

Package Insert - ABRYSVO (STN 125769)

ABRYSVO is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory ...

7.

abrysvoadult.pfizerpro.com

abrysvoadult.pfizerpro.com/about-abrysvo/efficacy-profile

About ABRYSVO® (Respiratory Syncytial Virus Vaccine)

See risks and benefits. Choose ABRYSVO® (Respiratory Syncytial Virus Vaccine) to help protect patients from RSV (respiratory syncytial virus).

8.

ema.europa.eu

ema.europa.eu/en/documents/product-information/abrysvo-epar-product-information_en.pdf

Abrysvo, INN-respiratory syncytial virus vaccine ... - EMA

Safety and immunogenicity have been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy (see sections 4.8 and 5.1).

9.

cdc.gov

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

RSV Vaccination for Adults 60 Years of Age and Over

The vaccine is supplied as a single-dose vial of 120 μg of lyophilized preF antigen component to be reconstituted with the accompanying vial of AS01E adjuvant ...