RSV Vaccine for Adults 60+ (RSV OA=ADJ=012 Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: GlaxoSmithKline
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
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.
Is the RSVPreF3 OA vaccine a promising drug for adults over 60?The RSVPreF3 OA vaccine, also known as Arexvy, is a promising drug for adults over 60 because it is designed to protect against RSV, a virus that can cause serious lung infections in older adults. This vaccine could help keep older adults healthier by preventing these infections.12346
What safety data is available for the RSV vaccine for adults 60+?The RSVPreF3 OA vaccine, also known as Arexvy, has been evaluated in several studies. A Phase 2b study found that two doses of the vaccine were well tolerated in older adults. A Phase 3 trial showed the vaccine was effective and safe in older adults with chronic conditions. A Phase 1 study in Japanese adults aged 60-80 also assessed the vaccine's safety and found it to be well tolerated. Additionally, a Phase 1/2 study evaluated the vaccine with and without an adjuvant in adults aged 65-85, focusing on safety and immunogenicity.5781011
What data supports the idea that RSV Vaccine for Adults 60+ (also known as: RSVPreF3 OA vaccine, Arexvy, RSVPreF3 OA) is an effective treatment?The available research shows that the RSV Vaccine for Adults 60+ is effective in preventing respiratory illnesses caused by RSV in older adults. In a study involving participants aged 60 and above, the vaccine was found to be effective against RSV-related lower respiratory tract disease and severe respiratory illness. This suggests that the vaccine can help protect older adults, especially those with existing health conditions, from serious RSV-related health issues.910111213
Do I have to stop taking my current medications for the RSV vaccine trial?The trial protocol does not specify if you must stop taking your current medications. However, you cannot use investigational or non-registered products 30 days before the first dose or during the study. Chronic use of immunosuppressants or immune-modifying drugs is not allowed 90 days before the first visit or during the study, except for inhaled and topical steroids.
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
I was in the RSV OA=ADJ-006 study and received either a placebo or one dose of the RSVPreF3 OA vaccine.
Exclusion Criteria
I have a condition or take medication that weakens my immune system.
I have recurring or uncontrolled seizures or neurological disorders.
I am bedridden.
I do not have any serious or unstable chronic illnesses.
I had a severe reaction to a vaccine in a previous study that may have been caused by the vaccine.
Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
GSK Investigational SiteSalisbury, NC
GSK Investigational SiteErie, PA
GSK Investigational SiteNewton, KS
GSK Investigational SiteFort Myers, FL
More Trial Locations
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
References
Efficacy and tolerability of continuous combined hormone replacement therapy in early postmenopausal women. [2018]Continuous combined hormone replacement therapy (ccHRT) based on estradiol valerate (E2V) and medroxyprogesterone acetate (MPA) is effective for relief of menopausal symptoms three years or more after the menopause. This study was undertaken to examine the efficacy and tolerability of ccHRT in early postmenopausal women (last menstrual period 1.3 years before study entry).
Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. [2017]Following primary vaccination of adults ⩾65years of age with 23-valent pneumococcal polysaccharide vaccine (PPSV23), immune responses increase and thereafter appear to decrease over time. With increased life expectancy worldwide, revaccination with PPSV23 may be required for continued protection of the elderly population against pneumococcal disease. The present study evaluated the immunogenicity and safety of revaccination with PPSV23 in the Japanese elderly.
Summary of the NACI Update on Herpes Zoster Vaccines. [2023]Steep increases in herpes zoster (HZ) incidence, hospitalization due to HZ and the risk of post-herpetic neuralgia as a complication of HZ occur in people over 50 years of age. Two HZ vaccines are currently authorized for use in those 50 years of age and older in Canada: a live attenuated zoster vaccine (LZV) authorized in 2008; and a recombinant subunit vaccine (RZV) authorized in October 2017.
Which patients should receive the herpes zoster vaccine? [2020]The recombinant adjuvanted zoster vaccine (RZV, trade name Shingrix) is preferentially recommended by the Advisory Committee on Immunization Practices to prevent herpes zoster and related complications in immunocompetent adults age 50 years and older. This article reviews efficacy and safety of the vaccine, its use in special populations, and how to prevent administration errors to answer the question "Which patients should receive the herpes zoster vaccine?"
A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. [2023]Respiratory syncytial virus (RSV) is an important cause of disease in older adults. We evaluated the safety and immunogenicity of a stabilized RSV prefusion F subunit (RSVpreF) vaccine candidate with/without adjuvant in adults aged 65-85 years.
Efficacy, effectiveness, and safety of herpes zoster vaccine in the immunocompetent and immunocompromised subjects: A systematic review and network meta-analysis. [2022]To investigate the efficacy, effectiveness and safety of recombinant zoster vaccine (RZV) and zoster vaccine live (ZVL) in immunocompetent and immunocompromised subjects.
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]Label="BACKGROUND" NlmCategory="BACKGROUND">Respiratory syncytial virus (RSV) causes lower respiratory tract infection, with a high burden of disease among adults ≥60 years. This study assessed the safety, reactogenicity, and immunogenicity of an investigational adjuvanted RSV vaccine (RSVPreF3/AS01B) in Japanese adults aged 60-80 years.
In older adults, an Ad26.RSV.preF-RSV preF protein vaccine reduced RSV-related lower respiratory tract disease. [2023]Label="SOURCE CITATION">Falsey AR, Williams K, Gymnopoulou E, et al; CYPRESS Investigators. Efficacy and safety of an Ad26.RSV.preF-RSV preF protein vaccine in older adults. N Engl J Med. 2023;388:609-620. 36791161.
Cost-Effectiveness of Prefusion F Protein-Based Vaccines Against Respiratory Syncytial Virus Disease for Older Adults in the United States. [2023]Two prefusion F protein-based vaccines, Arexvy and Abrysvo, have been authorized by the US Food and Drug Administration for protecting older adults against Respiratory Syncytial Virus (RSV)-associated lower respiratory tract illness. We evaluated the health benefits and cost-effectiveness of these vaccines.
Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. [2023]Older adults with chronic cardiorespiratory or endocrine/metabolic conditions are at increased risk of respiratory syncytial virus (RSV)-related acute respiratory illness (RSV-ARI) and severe respiratory disease. In an ongoing, randomized, placebo-controlled, multicountry, phase 3 trial in ≥60-year-old participants, an AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD), severe RSV-LRTD, and RSV-ARI. We evaluated efficacy and immunogenicity among participants with coexisting cardiorespiratory or endocrine/metabolic conditions that increase the risk of severe RSV disease ("conditions of interest").
Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. [2023]In the previous (parent) study, 2 doses of different formulations of an investigational vaccine against respiratory syncytial virus (RSVPreF3 OA) were well tolerated and immunogenic in older adults. This multicenter phase 2b extension study assessed safety and immunogenicity of a revaccination (third) dose of the 120 μg RSVPreF3-AS01E formulation.
Immunogenicity of an AS01-adjuvanted respiratory syncytial virus prefusion F (RSVPreF3) vaccine in animal models. [2023]Respiratory syncytial virus (RSV) causes a high disease burden in older adults. An effective vaccine for this RSV-primed population may need to boost/elicit robust RSV-neutralizing antibody responses and recall/induce RSV-specific T cell responses. To inform the selection of the vaccine formulation for older adults, RSVPreF3 (RSV fusion glycoprotein engineered to maintain the prefusion conformation) with/without AS01 adjuvant was evaluated in mice and bovine RSV infection-primed cattle. In mice, RSVPreF3/AS01 elicited robust RSV-A/B-specific neutralization titers and RSV F-specific polyfunctional CD4+ T cell responses exceeding those induced by non-adjuvanted RSVPreF3. In primed bovines, RSVPreF3/AS01 tended to induce higher pre-/post-vaccination fold-increases in RSV-A/B-specific neutralization titers relative to non-adjuvanted and Alum-adjuvanted RSVPreF3 formulations, and elicited higher RSV F-specific CD4+ T cell frequencies relative to the non-adjuvanted vaccine. Though AS01 adjuvanticity varied by animal species and priming status, RSVPreF3/AS01 elicited/boosted RSV-A/B-specific neutralization titers and RSV F-specific CD4+ T cell responses in both animal models, which supported its further clinical evaluation as prophylactic candidate vaccine for older adults.
Cost-effectiveness of Prefusion F Protein-based Vaccines Against Respiratory Syncytial Virus Disease for Older Adults in the United States. [2023]Two prefusion F protein-based vaccines, Arexvy and Abrysvo, have been authorized by the US Food and Drug Administration for protecting older adults against respiratory syncytial virus (RSV)-associated lower respiratory tract illness. We evaluated the health benefits and cost-effectiveness of these vaccines.