15500 Participants Needed

RSV Vaccine for Adults 60+

(RSV OA=ADJ=012 Trial)

Recruiting at 213 trial locations
EG
UG
Overseen ByUS GSK Clinical Trials Call Center
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the RSV vaccine trial?

The trial does not specify that you need to stop taking your current medications. However, if you are on immunosuppressants or immune-modifying drugs, you may need to stop them 90 days before the study starts. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the RSVPreF3 OA vaccine, Arexvy, for adults 60+?

Research shows that the RSVPreF3 OA vaccine is effective in older adults, especially those with existing health conditions, in preventing severe respiratory illnesses caused by RSV. The vaccine has been shown to boost the body's immune response, making it a promising option for protecting older adults from RSV-related diseases.12345

Is the RSVPreF3 OA vaccine safe for adults aged 60 and over?

The RSVPreF3 OA vaccine has been tested in several studies and was generally well tolerated in older adults, meaning it did not cause serious side effects. It was tested in different formulations and doses, and participants in these studies did not experience major safety issues.12678

How is the RSVPreF3 OA vaccine different from other drugs for RSV in adults 60+?

The RSVPreF3 OA vaccine is unique because it specifically targets the respiratory syncytial virus (RSV) in adults aged 60 and older, a group for which there are limited existing vaccines. This vaccine is designed to boost the immune system's response to RSV, potentially offering better protection for older adults who are more vulnerable to severe RSV infections.910111213

What is the purpose of this trial?

The purpose of this study is:* To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose,* To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine,* To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Eligibility Criteria

This trial is for adults aged 60 and above who previously took part in the RSV OA=ADJ-006 study. It's designed to assess the timing for a second vaccine dose, long-term safety, and immune response over approximately five RSV seasons.

Inclusion Criteria

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications)
Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure
I was in the RSV OA=ADJ-006 study and received either a placebo or one dose of the RSVPreF3 OA vaccine.
See 1 more

Exclusion Criteria

I have a condition or take medication that weakens my immune system.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention
Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Revaccination

Participants receive a dose of RSVPreF3 OA vaccine before RSV Season 4 or 5, or a single dose in the crossover group

1 week
1 visit (in-person)

Long-term Follow-up

Participants are monitored for immune persistence and safety up to 5 consecutive RSV seasons

60 months

Treatment Details

Interventions

  • RSVPreF3 OA vaccine
Trial Overview The study tests the RSVPreF3 OA vaccine's effectiveness in preventing Respiratory Syncytial Virus (RSV). Participants will either receive a follow-up dose or their first actual vaccine if they initially received a placebo.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: RSV_PreS5Experimental Treatment1 Intervention
Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.
Group II: RSV_PreS4Experimental Treatment1 Intervention
Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.
Group III: CrossoverExperimental Treatment1 Intervention
Participants in this group will receive a single dose of RSVPreF3 OA vaccine.
Group IV: RSV_1DoseActive Control1 Intervention
Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine.

RSVPreF3 OA vaccine is already approved in United States for the following indications:

🇺🇸
Approved in United States as Arexvy for:
  • Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older

Find a Clinic Near You

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 profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

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.
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]
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.
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]
Vaccination with Arexvy and Abrysvo can significantly reduce the health burden of respiratory syncytial virus (RSV) in older adults, leading to fewer hospitalizations and deaths, making it a valuable intervention for this age group.
The cost-effectiveness analysis suggests that these vaccines could be economically viable, with a maximum price-per-dose of $127 for Arexvy and $118 for Abrysvo, potentially rising to $235 and $245 respectively if benefits extend into a second RSV season.
Cost-effectiveness of Prefusion F Protein-based Vaccines Against Respiratory Syncytial Virus Disease for Older Adults in the United States.Moghadas, SM., Shoukat, A., Bawden, CE., et al.[2023]

References

Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. [2023]
Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. [2023]
Cost-effectiveness of Prefusion F Protein-based Vaccines Against Respiratory Syncytial Virus Disease for Older Adults in the United States. [2023]
Cost-Effectiveness of Prefusion F Protein-Based Vaccines Against Respiratory Syncytial Virus Disease for Older Adults in the United States. [2023]
Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. [2023]
Safety and immunogenicity of a respiratory syncytial virus prefusion F protein (RSVPreF3) candidate vaccine in older Japanese adults: A phase I, randomized, observer-blind clinical trial. [2023]
A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. [2023]
In older adults, an Ad26.RSV.preF-RSV preF protein vaccine reduced RSV-related lower respiratory tract disease. [2023]
Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Which patients should receive the herpes zoster vaccine? [2020]
Summary of the NACI Update on Herpes Zoster Vaccines. [2023]
Efficacy and tolerability of continuous combined hormone replacement therapy in early postmenopausal women. [2018]
Efficacy, effectiveness, and safety of herpes zoster vaccine in the immunocompetent and immunocompromised subjects: A systematic review and network meta-analysis. [2022]
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