Vaccine for Respiratory Syncytial Virus

No longer recruiting at 59 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must not be taking: Immune-modifying drugs

Disqualifiers: Immunosuppressive conditions, Dementia, 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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, RSVPreF3 OA, designed to boost the immune response and ensure safety against respiratory syncytial virus (RSV) in adults. It targets two groups: adults aged 18-49 with conditions such as chronic lung or heart disease, asthma, or diabetes that increase RSV risk, and older adults aged 60 and above. Participants in both groups should have stable conditions and manage daily activities independently. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking medical advancements.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you cannot use any investigational or non-registered products 30 days before and during the study, and chronic use of immune-modifying drugs is not allowed. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that the RSVPreF3 OA investigational vaccine is likely to be safe for humans?

Research shows that the RSVPreF3 OA vaccine is generally safe. In earlier studies, adults aged 60 and above received the vaccine, and it proved safe for most participants. Very few experienced serious side effects; in fact, less than 1% in one study encountered major problems after vaccination.

The vaccine not only demonstrated safety but also effectively prevented RSV-related illnesses. Participants tolerated the vaccine well, even with a second dose a year later.

While discussing concerns with a healthcare professional is advisable, evidence so far indicates that this vaccine is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for respiratory syncytial virus (RSV), which often involves supportive treatments like oxygen therapy and antiviral medications such as ribavirin, the RSVPreF3 OA investigational vaccine offers a proactive approach by aiming to prevent the infection in the first place. This vaccine is unique because it targets the RSV fusion protein, a key part of the virus that helps it infect cells, potentially stopping the virus before it can cause illness. Researchers are excited because this vaccine could provide significant protection, especially for older adults and those at increased risk, offering a new level of defense against RSV that current treatments cannot.

What evidence suggests that the RSVPreF3 OA investigational vaccine might be an effective treatment for RSV?

Research has shown that the RSVPreF3 OA vaccine effectively prevents illnesses caused by the respiratory syncytial virus (RSV). Studies found that one dose of this vaccine can prevent 67.2% of lower lung infections from RSV and 78.8% of severe RSV-related illnesses. The vaccine has been tested over several seasons and consistently provides protection. Additionally, it is generally considered safe. In this trial, participants from different groups, such as older adults and adults at increased risk, will receive a single dose of the RSVPreF3 OA investigational vaccine to further evaluate its effectiveness and safety. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for non-immunocompromised adults aged 18-49 at increased risk for RSV disease, and older adults aged 60+. Key eligibility details are not provided, so interested individuals should contact the study organizers for full inclusion and exclusion criteria.

Inclusion Criteria

Written informed assent obtained from the participant if he/she is less than the legal age prior to performance of any study-specific procedure

Participants living in the general community or in an assisted-living facility that provides minimal assistance

Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) prior to performance of any study-specific procedure

Exclusion Criteria

Unstable chronic illness

Use of any investigational or non-registered product other than the study intervention

Concurrent participation in another clinical study involving exposure to an investigational vaccine/product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RSVPreF3 OA investigational vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• RSVPreF3 OA investigational vaccine

Trial Overview The study tests the immune response and safety of an investigational vaccine called RSVPreF3 OA. It compares how younger adults (18-49) at higher risk respond to the vaccine versus those who are older (60+).

How Is the Trial Designed?

Group I: Part B: RSV-A-AIR Group Experimental Treatment 1 Intervention

Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.

Group II: Part A: RSV-A-AIR Group Experimental Treatment 1 Intervention

Adult (A) participants, 18-49 YOA, at increased risk (AIR) for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.

Group III: Part A: RSV-OA Group Active Control 1 Intervention

Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38253338/

Efficacy and Safety of Respiratory Syncytial Virus (RSV) ... Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2-80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6-92.0%) against severe ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209604

Respiratory Syncytial Virus Prefusion F Protein Vaccine in ... A single dose of the RSVPreF3 OA vaccine had an acceptable safety profile and prevented RSV-related acute respiratory infection and lower respiratory tract ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04886596

NCT04886596 | Efficacy Study of GSK's Investigational ... This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥ ...

4. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(25)00048-7/abstract

Efficacy, safety, and immunogenicity of ... Cumulative efficacy over three seasons of one RSVPreF3 OA dose was 62·9% (97·5% CI 46·7–74·8) against RSV-LRTD, 69·8% (42·2–85·7) against RSV A- ...

5. cidrap.umn.edu cidrap.umn.edu/respiratory-syncytial-virus-rsv/trial-shows-waning-efficacy-rsv-vaccine-across-3-seasons-older

Trial shows waning efficacy of RSV vaccine across 3 ... The cumulative efficacy of a single RSVPreF3 OA dose in preventing RSV-related lower respiratory tract disease over three RSV seasons was 62.9% ...

6. academic.oup.com academic.oup.com/cid/article/78/6/1732/7585312

Efficacy and Safety of Respiratory Syncytial Virus (RSV ... One RSVPreF3 OA dose was efficacious against respiratory syncytial virus (RSV)–related lower respiratory tract disease during at least 2 RSV seasons in ≥60.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06389487

NCT06389487 | A Study on the Immune Response and ... The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260025000487

Articles Efficacy, safety, and immunogenicity of the AS01 E ... RSVPreF3 OA showed a clinically acceptable safety profile. Between dose one and trial end, eight (<1%) participants in the RSV single-dose group, 12 (<1%) in ...