Clinical trial NCT06374394: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV
Respiratory Syncytial Virus
COVID-19 mRNA vaccine
Immunogenicity
Safety
Reactogenicity
Older Adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 842
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: RSV-A neutralization titers
timeFrame: At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group)
measure: RSV-B neutralization titers
timeFrame: At 1 month post-RSVPreF3 OA investigational vaccine dose administration (Day 31 for Co-ad Group and Day 61 for Control Group)
measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein
timeFrame: At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31)
Secondary outcomes:
measure: RSV-A neutralization titers expressed as GMT
timeFrame: At 1 month after study intervention administration (Day 31 for Co-ad Group and Day 61 for Control Group)
measure: RSV-A neutralization titers expressed as Mean Geometric Increase (MGI)
timeFrame: 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)
measure: RSV-A neutralization titers expressed as Seroresponse Rate (SRR)
timeFrame: 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)
measure: Percentage of participants having RSV-A neutralizing titers >= assay cut-off value
timeFrame: 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)
measure: RSV-B neutralization titers expressed as GMT
timeFrame: At pre-study intervention administration and 1 month after study intervention administration (Day 31 for Co-ad Group and Day 61 for Control Group)
measure: RSV-B neutralization titers expressed as MGI
timeFrame: 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)
measure: RSV-B neutralization titers expressed as SRR
timeFrame: 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)
measure: Percentage of participants having RSV-B neutralizing titers >= assay cut-off value
timeFrame: 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)
measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT
timeFrame: At 1 month after study intervention administration (Day 31 for both groups)
measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI
timeFrame: At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31) compared to pre-vaccination (at Day 1)
measure: Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value
timeFrame: 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)
measure: Percentage of participants reporting each solicited administration site event
timeFrame: 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)
measure: Percentage of participants reporting each solicited systemic event
timeFrame: 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)
measure: Percentage of participants reporting unsolicited adverse events (AEs)
timeFrame: 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)
measure: Percentage of participants reporting serious adverse events (SAEs)
timeFrame: 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)
measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs)
timeFrame: 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)
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: North Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Kluisbergen
country: Belgium
facility: GSK Investigational Site
city: Mechelen
country: Belgium
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Zutphen
country: Netherlands
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Boadilla Del Monte Madrid
country: Spain
facility: GSK Investigational Site
city: La CoruNa
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
Study officials:
References: