RSV Vaccine for Older Adults

Recruiting at 41 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

1720 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the RSVPreF3 OA investigational vaccine treatment for older adults?

Research shows that the RSVPreF3 OA vaccine is effective in older adults, especially those with existing health conditions, by reducing the risk of severe respiratory diseases caused by RSV. Studies also indicate that the vaccine is well-tolerated and boosts the immune response, making it a promising option for preventing RSV-related illnesses in this age group. ^{1 2 3 4 5}

Is the RSVPreF3 OA investigational vaccine safe for older adults?

In studies, the RSVPreF3 OA investigational vaccine was generally well tolerated in older adults, meaning it did not cause serious side effects. ^{1 2 5 6 7}

How is the RSVPreF3 OA vaccine different from other treatments for RSV in older adults?

The RSVPreF3 OA vaccine is unique because it is designed to prevent RSV-related lower respiratory tract disease in older adults, whereas other treatments like aerosolized ribavirin are used to treat RSV infections after they occur, particularly in immunocompromised patients. The vaccine works by stimulating the immune system to recognize and fight the virus before infection, unlike ribavirin, which is used to manage symptoms and complications after infection. ^{8 9 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: 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 the study end (Month 60).

Group II: 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 the study end (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 and RSV_1dose_flexible groups), which will be followed up until the study end (Month 60).

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

Findings from Research

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 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]

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 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]

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]

References

1. United States 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. [2023]

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

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. [2023]

4. United States 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. [2022]

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

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

6. United States 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. [2023]

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

Phase 1 Safety and Immunogenicity Study of a Respiratory Syncytial Virus Vaccine With an Adenovirus 26 Vector Encoding Prefusion F (Ad26.RSV.preF) in Adults Aged ≥60 Years. [2021]

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

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

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

The Use of Aerosolized Ribavirin in Respiratory Syncytial Virus Lower Respiratory Tract Infections in Adult Immunocompromised Patients: A Systematic Review. [2021]

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

Early Phase Clinical Immunogenicity of Valoctocogene Roxaparvovec, an AAV5-Mediated Gene Therapy for Hemophilia A. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

A multicenter pharmacosurveillance study for the evaluation of the efficacy and safety of recombinant factor VIII in the treatment of patients with hemophilia A. German Kogenate Study Group. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety and pharmacokinetics of recombinant human coagulation factor VIII (omfiloctocog alfa) in previously treated Chinese children with severe hemophilia A. [2022]