RSV Vaccine for Older Adults

Not currently recruiting at 49 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must not be taking: Immunosuppressants, Immune-modifying drugs

Disqualifiers: Immunodeficient conditions, Dementia, Unstable illness, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine designed to protect against RSV, a virus that can cause serious lung infections. It aims to determine the vaccine's safety and effectiveness over time, with some participants receiving one dose and others receiving additional doses on different schedules. The trial seeks individuals aged 60 and older who are generally healthy, even if they manage stable conditions like diabetes or high blood pressure. Participants should not have any serious or unstable illnesses. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking 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, you cannot take investigational products, certain vaccines, or immune-modifying drugs during specific periods before and during the study. It's best to discuss your medications with the study team.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that the RSVPreF3 OA vaccine is generally safe for older adults. One study found that a single dose effectively protected individuals aged 60 and above from RSV-related breathing problems for at least two RSV seasons, suggesting it is well-tolerated over time. Another study confirmed the vaccine's safety for those aged 50 and over, with no major safety concerns.

Additionally, the vaccine was administered safely alongside other vaccines, such as those for the flu and pneumonia, in older adults, without causing new safety issues. While all treatments can have some side effects, these findings indicate that the RSVPreF3 OA vaccine is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the RSVPreF3 OA investigational vaccine for older adults because it offers a novel approach to preventing Respiratory Syncytial Virus (RSV) infections, which are particularly risky for this age group. Unlike traditional supportive care methods, this vaccine specifically targets the virus by introducing a stabilized prefusion F protein, a key component in helping the immune system recognize and fight RSV. The study explores different dosing strategies, such as a single dose, annual revaccination, and a flexible revaccination schedule, potentially offering more tailored protection compared to existing options. This flexibility in dosing could lead to more effective, long-lasting immunity, making it a promising advancement in the fight against RSV.

What evidence suggests that this trial's vaccine could be effective for RSV in older adults?

Studies have shown that the RSVPreF3 OA vaccine helps protect older adults from serious lung infections caused by RSV. For individuals aged 60 and over, one dose of the vaccine proved about 63% effective in preventing these issues over three RSV seasons. In this trial, participants in the RSV_1dose Group will receive one dose of the RSVPreF3 OA investigational vaccine. Meanwhile, those in the RSV_annual Group will receive one dose initially and two additional doses at 12 and 24 months. Participants in the RSV_flexible revaccination Group will receive one dose initially and two additional doses at 24 and 48 months. Research has also shown that the vaccine is safe and well-tolerated, even with an additional dose a year later. This indicates that the vaccine not only works well but is also safe for older adults. These findings are promising for reducing the impact of RSV in this age group. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol

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

Exclusion Criteria

You have a severe or unstable long-term illness.

History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures

Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Vaccination

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial vaccination

6 months

Revaccination and Long-term Follow-up

Participants receive additional vaccine doses according to different revaccination schedules and are followed up until Month 60

60 months

What Are the Treatments Tested in This Trial?

Interventions

• RSVPreF3 OA investigational vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: RSV_annual Group Experimental Treatment 1 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 Month 60.

Group II: RSV_Flexible revaccination Group Experimental Treatment 1 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 Month 60.

Group III: RSV_1dose Group Experimental Treatment 1 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 (which will receive 1 additional revaccination dose at Month 36 and will be followed up until Month 60) and RSV\_1dose\_Flexible (which will receive 1 additional revaccination dose at Month 60, and will be followed up until study end at Month 72).

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

Published Research Related to This Trial

The study evaluated the safety and efficacy of a prefusion F protein vaccine against respiratory syncytial virus (RSV) in older adults, demonstrating a significant reduction in RSV-related respiratory illnesses.

The vaccine was well-tolerated with a favorable safety profile, indicating its potential as a preventive measure for RSV in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In older adults, an AS01E-adjuvanted RSVPreF3 OA vaccine reduced RSV-related lower respiratory tract disease. Awar, M., Mylonakis, E.[2023]

The Ad26.RSV.preF vaccine candidate showed good safety and immunogenicity in a study involving 12 adults and 36 RSV-seropositive children, with no serious adverse events reported and only mild to moderate reactions observed.

The vaccine significantly increased RSV neutralization titers in children and resulted in fewer RSV infections compared to the placebo group, indicating its potential effectiveness in preventing RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. Stuart, ASV., Virta, M., Williams, K., et al.[2023]

In a study involving 122 older adults, a third dose of the RSVPreF3-AS01E vaccine was found to be well tolerated, with mostly mild-to-moderate side effects and no serious adverse events reported, indicating a good safety profile.

The third dose significantly boosted RSV-specific neutralizing antibodies and T-cell responses, demonstrating its immunogenicity, although the antibody levels after the third dose were lower than those observed one month after the first dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. Leroux-Roels, I., Van Ranst, M., Vandermeulen, C., et al.[2023]

The RSVPreF3 vaccine combined with the AS01 adjuvant significantly boosted RSV-neutralizing antibody responses and T cell responses in both mice and cattle, indicating its potential effectiveness for older adults.

In both animal models, the RSVPreF3/AS01 formulation outperformed non-adjuvanted versions in generating stronger immune responses, suggesting it is a promising candidate for further clinical evaluation as a vaccine for RSV in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. Bouzya, B., Rouxel, RN., Sacconnay, L., et al.[2023]

The investigational bivalent prefusion F vaccine (RSVpreF) was well tolerated in healthy adults aged 18-85, with mostly mild to moderate side effects, indicating a favorable safety profile.

RSVpreF elicited strong immune responses in older adults, significantly increasing serum-neutralizing antibodies against RSV, suggesting it could effectively protect this vulnerable population from RSV disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. Falsey, AR., Walsh, EE., Scott, DA., et al.[2022]

The RSVPreF3 OA vaccine demonstrated high efficacy against RSV-related lower respiratory tract disease (94.6%) and acute respiratory illness (81.0%) in older adults with coexisting cardiorespiratory or endocrine/metabolic conditions, indicating it is effective for those at higher risk.

Immunogenicity results showed that post-vaccination neutralizing antibody levels in participants with these conditions were comparable to those without, suggesting that the vaccine is safe and effective across different health statuses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Feldman, RG., Antonelli-Incalzi, R., Steenackers, K., et al.[2023]

Citations

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

Efficacy and Safety of Respiratory Syncytial Virus (RSV) ... One RSVPreF3 OA dose was efficacious against RSV-LRTD over 2 RSV seasons in ≥60-year-olds. Revaccination 1 year post-dose 1 was well tolerated.

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

Respiratory Syncytial Virus Prefusion F Protein Vaccine in ... In this trial, we found that a single dose of the RSVPreF3 OA vaccine was efficacious against RSV-related lower respiratory tract disease, RSV- ...

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

Efficacy, safety, and immunogenicity of ... A single RSVPreF3 OA dose was efficacious against RSV-LRTD over three RSV seasons in people aged 60 years or older, despite a decrease in ...

4. jwatch.org jwatch.org/na58690/2025/06/02/how-well-do-rsv-vaccines-work-older-people

How Well Do RSV Vaccines Work in Older People? One dose of vaccine RSVpreF3 OA was 63% efficacious at preventing RSV-associated lower respiratory disease over three consecutive seasons.

5. 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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38981954/

Randomized, Open-Label Phase 3 Study Evaluating ... This study supports the coadministration of RSVPreF3 OA and FLU-QIV-HD in adults aged 65 years or older.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05879107?tab=results

NCT05879107 | Study to Assess the Immune Response, ... Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) ...

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. ... vaccine for respiratory syncytial virus prevention among adults aged 50 years and older in Germany.

9. pulmonologyadvisor.com pulmonologyadvisor.com/news/rsv-vaccine-single-dose-rsvpref3-oa-effective-for-3-seasons/

RSV Vaccine in Older Adults: Single RSVPreF3 OA Dose ... A single dose of RSVPreF3 OA was effective for 3 RSV seasons in study participants but with varying efficacy rates, depending upon age group and ...