RSV Vaccine for Respiratory Syncytial Virus

(PICASSO Trial)

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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new vaccine called RSVpreF in children aged 2 to under 18 years. The goal is to find a safe and effective dose that helps their immune system fight off the RSV virus. Participants will receive one injection and have several follow-up visits over a period of time.

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.

How is the RSVpreF vaccine different from other RSV treatments?

The RSVpreF vaccine is unique because it is designed to protect both infants and older adults from RSV by targeting the prefusion F protein of the virus, which is crucial for its ability to infect cells. It is approved for use in pregnant individuals to help protect their infants, making it the first maternal vaccine for RSV. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2023]

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

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

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

A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. [2022]

5. 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]