A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Phase 3, Open-label, Randomized, Controlled Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With a COVID-19 mRNA Vaccine (Omicron XBB.1.5) in Adults Aged 50 Years and Above

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374394
• Other study ID #: 217848
• Secondary ID: 2023-510196-59-0
• Status: Recruiting
• Phase: Phase 3
• Start date: April 29, 2024
• Est. completion date: May 21, 2025

Study information

• Verified date: June 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

This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: May 21, 2025
• Est. primary completion date: December 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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, return for follow-up visits).

Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home). However, at no time will the site staff or caregiver evaluate the participant's health status while answering diaries or make decisions on behalf of the participant.

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

• A male/female of =50 Years of age (YOA) at the time of the first study intervention administration.

• Participants who are medically stable in the opinion of the investigator at the time of first vaccination. 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 by the investigator as medically stable.

A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.

• 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.

Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination.

• Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and 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 agreed to continue adequate contraception for at least 1 month after the last vaccination.

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

Exclusion Criteria:

Medical Conditions

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including a known history of severe allergic reaction (e.g., anaphylaxis).

• 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).

• Any history of myocarditis or pericarditis.

• Recurrent history 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 diary cards, attend regular phone calls/study site visits).

• Serious or unstable chronic illness.

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

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

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

• Any SAE attributed to a previous dose of the SARS-CoV-2 mRNA vaccine.

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

• Recent SARS-CoV-2 infection within 3 months prior to the COVID-19 vaccine dose administration. Timelines to be determined from symptoms onset or positive COVID-19 test (if infection was asymptomatic).

Prior/Concomitant Therapy Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions and ending 30 days after the last vaccine administration, or their planned use during the study period.

• Planned administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention(s) administration*, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after the study vaccination.

*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and Sponsor is notified.

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

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

• For corticosteroids, this will mean prednisone equivalent = 20 mg/day. Inhaled and topical 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., TNF-inhibitors), monoclonal antibodies and antitumoral medication.

• Administration of any SARS-CoV-2 vaccine during the 3 months preceding the study COVID-19 mRNA vaccine administration.

• Previous vaccination with licensed or investigational RSV vaccine. 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 intervention (drug/invasive medical device).

Other Exclusion Criteria

• Pregnant or lactating female participant.

• Female participant planning to become pregnant or planning to discontinue contraceptive precautions.

• 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.

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

• Planned move during the study conduct that prohibits participation until study end.

• Bedridden participants.

Related Conditions & MeSH terms

• COVID-19
• Respiratory Syncytial Virus Infections

Intervention

Biological:
• RSVPreF3 OA investigational vaccine
1 dose of RSVPreF3 OA investigational vaccine is administered intramuscularly on Day 1 to participants in the Co-ad Group and on Day 31 to participants in the Control Group.
• COVID-19 mRNA vaccine
1 dose of COVID-19 mRNA vaccine is administered intramuscularly on Day 1 to participants in the Co-ad and Control Groups.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Kluisbergen
Belgium	GSK Investigational Site	Mechelen
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Zutphen
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Boadilla del Monte	Madrid
Spain	GSK Investigational Site	Coruña
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Newport News	Virginia
United States	GSK Investigational Site	North Charleston	South Carolina
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Secaucus	New Jersey
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSV-A neutralization titers	RSV A neutralization titers will be given as group Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).	At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group)
Primary	RSV-B neutralization titers	RSV-B neutralization titers will be given as group GMTs and expressed as Estimated Dilution 60 (ED60).	At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group)
Primary	SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein	SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein will be given as group GMTs and expressed as Estimated Dilution 60 (ED60).	At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31)
Secondary	RSV-A neutralization titers expressed as GMT	Serological assays for the determination of antibodies against RSV-A will be performed by neutralization assay. The corresponding antibody titers will be expressed in ED60.	At 1 month after study intervention administration (Day 31 for Co-ad Group and Day 61 for Control Group)
Secondary	RSV-A neutralization titers expressed as Mean Geometric Increase (MGI)	Mean geometric increase (MGI) is defined as the geometric mean of the within subject ratios of the post-dose titer over the pre-dose titer.	At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-ad Group and Day 31 for Control Group)
Secondary	RSV-A neutralization titers expressed as Seroresponse Rate (SRR)	The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to (=) 4.	At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group) compared to baseline (Day 1 for Co-ad Group and Day 31 for Control Group)
Secondary	Percentage of participants having RSV-A neutralizing titers >= assay cut-off value		At pre-vaccination (Day 1 for Co-ad Group and Day 31 for Control) and at 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group)
Secondary	RSV-B neutralization titers expressed as GMT	Serological assays for the determination of antibodies against RSV-B will be performed by neutralization assay. The corresponding antibody titers will be expressed in ED60.	At pre-study intervention administration and 1 month after study intervention administration (Day 31 for Co-ad Group and Day 61 for Control Group)
Secondary	RSV-B neutralization titers expressed as MGI	MGI is defined as the geometric mean of the within subject ratios of the post-dose titer over the pre-dose titer.	At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-ad Group and Day 31 for Control Group)
Secondary	RSV-B neutralization titers expressed as SRR	The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1month post-study intervention administration over pre-study intervention administration) greater than or equal to (>=) 4.	At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group) compared to baseline (Day 1 for Co-ad Group and Day 31 for Control Group)
Secondary	Percentage of participants having RSV-B neutralizing titers >= assay cut-off value		At pre-vaccination (Day 1 for Co-ad Group and Day 31 for Control) and at 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group)
Secondary	SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT	Serological assays for the determination of antibodies against the S protein will be performed by neutralization assay. The corresponding antibody titers will be expressed in ED60.	At 1 month after study intervention administration (Day 31 for both groups)
Secondary	SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI	MGI is defined as the geometric mean of the within subject ratios of the post-dose titer over the pre-dose titer.	At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31) compared to pre-vaccination (at Day 1)
Secondary	Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value		At pre-vaccination (at Day 1 for both groups) and at 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31 for both groups)
Secondary	Percentage of participants reporting each solicited administration site event	The assessed solicited administration site events are pain at administration site, redness at administration and swelling at administration site.	Within 4 days post each study intervention administration (i.e., the day of vaccination and 3 subsequent days, vaccines administered at Day 1 for Co-ad Group and at Day 1 and Day 31 for Control Group)
Secondary	Percentage of participants reporting each solicited systemic event	The assessed solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).	Within 4 days post each study intervention administration (i.e., the day of vaccination and 3 subsequent days, vaccines administered at Day 1 for Co-ad Group and at Day 1 and Day 31 for Control Group)
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.	Within 30 days post each study intervention administration (i.e., the day of vaccination and 29 subsequent days, vaccines administered at Day 1 for Co-ad Group and at Day 1 and Day 31 for Control Group)
Secondary	Percentage of participants reporting serious adverse events (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.	From first study intervention administration (Day 1) up to study end (6 months after last study intervention administration, vaccines administered at Day 1 for Co-ad Group and at Day 1 and Day 31 for Control Group)
Secondary	Percentage of participants reporting potential immune-mediated diseases (pIMDs)	Potential immune-mediated diseases (pIMDs) are a subset of adverse event of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.	From first study intervention administration (Day 1) up to study end (6 months after last study intervention administration, vaccines administered at Day 1 for Co-ad Group and at Day 1 and Day 31 for Control Group)