A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389487
• Other study ID #: 222253
• Secondary ID: 2023-510190-34-0
• Status: Recruiting
• Phase: Phase 3
• Start date: April 29, 2024
• Est. completion date: April 25, 2025

Study information

• Verified date: May 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (>=) 60 YOA and above

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: April 25, 2025
• Est. primary completion date: August 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).

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

Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure.

Specific inclusion criteria for all participants in Cohort 1 • A male or female participant 18-49 YOA at the time of the study intervention administration.

• Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator:

• Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication:

o Chronic obstructive pulmonary disease (COPD)

o Asthma

o Cystic fibrosis

o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis

o Chronic heart failure:

o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified)

• Cardiac arrhythmia

• Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months

• Other diseases at increased risk for RSV disease:

• Chronic kidney disease

• Chronic moderate to severe liver disease

• Neurologic or neuromuscular conditions

• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.

• Female participants of childbearing potential may be enrolled in the study, if the participant:

• has practiced adequate contraception from 1 month prior to study intervention administration, and

• has a negative pregnancy test on the day of study prior to intervention administration, and

• has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration.

Specific inclusion criteria for all participants in Cohort 2

• A male or female participant >=60 YOA at the time of the study intervention administration.

Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator.

• Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.

Exclusion Criteria:

Medical conditions

• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.

• Unstable chronic illness.

• Any history of dementia or any medical condition that moderately or severely impairs cognition.

• Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g., completion of the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures.

• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).

• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

• Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3, Month 6).

• Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.

• Previous vaccination with any RSV vaccine, including investigational RSV vaccines.

• Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the End-of-study (EOS).

• Up to 3 months prior to the study intervention administration:

• For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed

• Administration of immunoglobulins and/or any blood products or plasma derivatives

• Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication.

Prior/Concurrent clinical study experience

• 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 (drug or invasive medical device).

Other exclusions:

Other exclusions for all participants

• 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.

• Bedridden participants.

• Planned move during the study period that will prohibit participating in the study until study end.

• Participation of any study personnel or their immediate dependents, family, or household members.

Other exclusions for Cohort 1

• Pregnant or lactating female participant.

• Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Biological:
• RSVPreF3 OA investigational vaccine
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1;

Locations

Country	Name	City	State
Australia	GSK Investigational Site	North Melbourne	Victoria
Australia	GSK Investigational Site	St Albans	Victoria
Australia	GSK Investigational Site	St Leonards	New South Wales
Australia	GSK Investigational Site	Tarragindi	Queensland
Canada	GSK Investigational Site	Guelph	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	New Westminster	British Columbia
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Québec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St-Charles-Borromée	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Victoria	British Columbia
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Boksburg	Gauteng
South Africa	GSK Investigational Site	Mowbray
South Africa	GSK Investigational Site	Newton
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	DeSoto	Texas
United States	GSK Investigational Site	Hialeah	Florida
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	North Hollywood	California
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Silver Spring	Maryland
United States	GSK Investigational Site	Tempe	Arizona
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Wenatchee	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Japan,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR)	RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated Dilution 60 (ED60).	At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
Primary	Seroresponse rate (SRR) in RSV-A neutralizing titers	SRR is defined as the proportion of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to (=) 4. RSV-A neutralizing titers are expressed as Estimated Dilution 60 (ED60).	At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
Primary	RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR)	RSV-B neutralizing titers are given as group GMTs and are expressed as Estimated Dilution 60 (ED60).	At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
Primary	SRR in RSV-B neutralizing titers	SRR is defined as the proportion of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) = 4. RSV-B neutralizing titers are expressed as Estimated Dilution 60 (ED60).	At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
Secondary	Percentage of participants reporting solicited administration site events	The assessed solicited administration site events are pain, redness and swelling at administration site.	During the 4-day follow up period after vaccination (vaccine administered at Day 1)
Secondary	Percentage of participants reporting solicited systemic events	The assessed solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever is defined as temperature >= 38.0 degrees Celsius (°C) /100.4 degrees Fahrenheit (°F), regardless of the location of . measurement. The route for measuring temperature can be oral or axillary.	During the 4-day follow up period after vaccination (vaccine administered at Day 1)
Secondary	Percentage of participants reporting unsolicited adverse events (AEs)	An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.	During the 30-day follow up period after vaccination (vaccine administered at Day 1)
Secondary	Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs	An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.	From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
Secondary	Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF)	pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. AEs of AF are considered as AESI.	From study intervention administration (Day 1) up to study end (Month 6 after study intervention administration)
Secondary	RSV-A neutralizing titers expressed as GMTs	RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).	At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration
Secondary	RSV-B neutralizing titers expressed as GMTs	RSV-B neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).	At pre-study intervention administration (Day 1), at Month 1 and Month 6 post-study intervention administration