What side effects are associated with this type of intervention?

Common side effects of vaccines that stimulate immune responses, such as mRNA COVID-19 vaccines and seasonal flu vaccines, include pain at the injection site, fatigue, headache, muscle pain, chills, fever, and nausea. These side effects are generally mild to moderate and resolve within a few days. Serious side effects are rare but can include severe allergic reactions (anaphylaxis).

What prior FDA approvals exist?

There have been several FDA-approved treatments and vaccines for respiratory infections, particularly for influenza and COVID-19. For COVID-19, mRNA vaccines such as those developed by Pfizer-BioNTech and Moderna have been widely approved and administered. For RSV, while there are no curative therapies, preventive measures like the monoclonal antibody palivizumab have been used in high-risk infants. The combined RSV and COVID-19 vaccine being studied aims to reduce the number of vaccinations by stimulating an immune response against both viruses, which is a novel approach in the context of healthy subjects.

What other types of research exist?

Promising alternatives to the combined RSV and COVID-19 vaccine for healthy subjects in 2024 include: 1) Heterologous prime-boost vaccination regimens, which have shown good efficacy against emerging SARS-CoV-2 variants. 2) MVA vector vaccines, which inhibit SARS-CoV-2 replication and prevent lethal disease in experimental models. 3) Humidified warmed CO2 treatment therapy, which may serve as a preventive measure and treatment against respiratory infections, including COVID-19.

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Virus Therapy

Combined Vaccine for COVID-19 Prevention

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after vaccination (day 28)

Summary

This trial tests a new combined vaccine for RSV and COVID-19 in adults aged 65 or older. The goal is to see if it is safe and effective. The combined vaccine aims to make it easier to stay protected against multiple respiratory infections.

Who is the study for?

This trial is for people aged 65 or older who are healthy or have stable chronic conditions. They must have had at least three US-authorized mRNA COVID-19 vaccines, with the last being a bivalent booster given over 150 days ago. Participants should not have received a flu shot in the past 120 days and must be able to attend all study visits and procedures.

What is being tested?

The trial is testing a combined vaccine against RSV and COVID-19, which may also be administered with a seasonal flu vaccine. The goal is to see if this combination can safely reduce the number of shots needed to prevent respiratory infections.

What are the potential side effects?

While specific side effects aren't listed, typical reactions could include soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. Severe allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after vaccination (day 28)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after vaccination (day 28)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after vaccination (day 28) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)

Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)

Group 1 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)

+8 more

Secondary study objectives

Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)

Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)

Group 6 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)

+4 more

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Group 7Experimental Treatment3 Interventions

Coadministration RSVpreF + bivalent BNT162b2 + QIV

Group II: Group 6Experimental Treatment3 Interventions

Coadministration RSVpreF + bivalent BNT162b2 + placebo

Group III: Group 2Experimental Treatment2 Interventions

Combination \[RSVpreF+BNT162b2\] + placebo

Group IV: Group 1Experimental Treatment2 Interventions

Combination \[RSVpreF+BNT162b2\] + Quadrivalent influenza vaccine (QIV)

Group V: Group 4Active Control2 Interventions

RSVpreF + placebo

Group VI: Group 5Active Control2 Interventions

QIV + placebo

Group VII: Group 3Active Control2 Interventions

BNT162b2 + placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bivalent BNT162b2 (original/Omi BA.4/BA.5)

2023

Completed Phase 2

~1090

Normal Saline Placebo

2023

Completed Phase 4

~1740

RSVpreF

2023

Completed Phase 3

~17130

Combination [RSVpreF+BNTb162b2]

2023

Completed Phase 2

~1090

QIV

2022

Completed Phase 3

~5550

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Vaccines are the most common treatments for healthy subjects to prevent infectious diseases. They work by stimulating the immune system to recognize and fight specific pathogens without causing the disease itself. For example, mRNA vaccines for COVID-19 instruct cells to produce a protein that triggers an immune response, while traditional vaccines may use inactivated viruses or viral proteins. This immune response prepares the body to fight the actual virus if exposed in the future. The combined RSV and COVID-19 vaccine aims to reduce the number of shots needed by providing protection against both viruses simultaneously, which is particularly beneficial for healthy subjects by simplifying vaccination schedules and enhancing compliance.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.