What side effects are associated with this type of intervention?

Common side effects of vaccines designed to elicit an immune response against Respiratory Syncytial Virus (RSV), such as the investigational RSVPreF3 OA vaccine, typically include mild to moderate reactions. These can involve pain at the injection site, redness, swelling, fatigue, headache, muscle pain, and fever. Severe adverse events are rare but can include allergic reactions. Overall, these vaccines are generally well-tolerated with a safety profile similar to other adult vaccines.

What prior FDA approvals exist?

The FDA has previously approved palivizumab, a monoclonal antibody, for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk. Palivizumab is not a vaccine but provides passive immunity by directly targeting the RSV virus. As of now, there are no FDA-approved vaccines for RSV, making the investigational RSVPreF3 OA vaccine a significant development in the field of active immunization against RSV.

What other types of research exist?

Promising novel alternatives to RSVPreF3 OA for RSV patients include: 1) mRNA-based RSV vaccines, which leverage the same technology used in some COVID-19 vaccines and are currently in clinical trials. 2) Monoclonal antibodies like nirsevimab, designed to provide passive immunity against RSV, especially in infants and high-risk populations. 3) Live-attenuated and vector-based vaccines, which are being developed to induce a robust immune response with potentially longer-lasting protection. These alternatives are in various stages of clinical evaluation and may offer effective options for RSV prevention and treatment in the near future.

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Virus Therapy

RSV Vaccine for Older Adults

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants)

Be older than 18 years old

Must not have

Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period

Bedridden participants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at month 36

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new RSV vaccine by GSK in adults aged 60 and above. The vaccine aims to boost the immune system's ability to fight RSV. The study will also look at how safe the vaccine is and how long its effects last.

Who is the study for?

Adults aged 60 or older, both from the community and long-term care facilities, can join this trial if they're medically stable. This includes those with controlled chronic conditions like diabetes or heart disease. People with severe allergies to vaccine ingredients, latex hypersensitivity, significant illnesses preventing study completion, recent use of immune-modifying drugs, a history of RSV vaccination or substance abuse cannot participate.

What is being tested?

The trial is testing an investigational RSV vaccine called RSVPreF3 OA in seniors. It aims to evaluate the safety and immune response up to three years after a single dose. The study will also look at how people respond to additional doses given on different schedules.

What are the potential side effects?

Potential side effects may include typical reactions at the injection site such as pain and swelling, general symptoms like fever or fatigue, allergic responses due to vaccine components, and other possible immune-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years or older and live at home or in a long-term care facility.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't used any experimental drugs or vaccines in the last 30 days and won't use any during the study.

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I am bedridden.

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I have been vaccinated against RSV before.

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I haven't received immunoglobulins or blood products in the last 90 days.

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I have a condition that affects my thinking or memory.

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I have a condition or take medication that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 36 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6

+5 more

Secondary study objectives

CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31

CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12

CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13

+55 more

Side effects data

From 2022 Phase 3 trial • 976 Patients • NCT04841577

53%

Injection site pain

23%

Fatigue

22%

Headache

22%

Myalgia

17%

Arthralgia

Injection site erythema

Injection site swelling

Pyrexia

Cough

Epistaxis

Death

Injection site bruising

Back pain

Upper respiratory tract infection

Oropharyngeal pain

Nausea

Pain

Neck pain

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Co-Ad Group

Control Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: RSV_flexible revaccination GroupExperimental Treatment1 Intervention

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until the study end (Month 60).

Group II: RSV_annual GroupExperimental Treatment1 Intervention

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until the study end (Month 60).

Group III: RSV_1dose GroupExperimental Treatment1 Intervention

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups (RSV_1dose_M36 and RSV_1dose_flexible groups), which will be followed up until the study end (Month 60).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVPreF3 OA investigational vaccine

2023

Completed Phase 3

~5970

0 / 7Eligibility criteria met

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

The investigational RSVPreF3 OA vaccine works by stimulating the immune system to produce antibodies against the Respiratory Syncytial Virus (RSV), thereby providing immunity and reducing the severity of future infections. This is crucial for RSV patients, especially older adults and infants, as it can prevent severe respiratory complications and hospitalizations. While current treatments for RSV are mainly supportive, such as oxygen therapy and hydration, the development of effective vaccines like RSVPreF3 OA represents a significant advancement in reducing the disease burden and improving patient outcomes.

New therapies for acute RSV infections: where are we?