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Trial record 1 of 1 for:    NCT05590403
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A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

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ClinicalTrials.gov Identifier: NCT05590403
Recruitment Status : Completed
First Posted : October 21, 2022
Results First Posted : May 21, 2024
Last Update Posted : May 21, 2024
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults >=60 YOA

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: RSVPreF3 OA investigational vaccine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer-blind for Cohort 1 (Day1-Day 31) and single-blind afterwards and open-label for Cohort 2
Primary Purpose: Prevention
Official Title: A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age
Actual Study Start Date : October 28, 2022
Actual Primary Completion Date : March 13, 2023
Actual Study Completion Date : April 3, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adults HA-RSV Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Biological: RSVPreF3 OA investigational vaccine
One dose administered intramuscularly at Day 1.

Placebo Comparator: Adults HA-Placebo Group
Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Drug: Placebo
One dose administered intramuscularly at Day 1.

Experimental: Adults AIR-RSV Group
Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Biological: RSVPreF3 OA investigational vaccine
One dose administered intramuscularly at Day 1.

Placebo Comparator: Adults AIR-Placebo Group
Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Drug: Placebo
One dose administered intramuscularly at Day 1.

Experimental: OA-RSV Group
Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Biological: RSVPreF3 OA investigational vaccine
One dose administered intramuscularly at Day 1.




Primary Outcome Measures :
  1. RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) ]
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

  2. RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
    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 (>=4).

  3. RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) ]
    Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

  4. RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1) ]
    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) >=4.

  5. RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
    Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

  6. RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1) ]
    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) >=4.

  7. RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA vaccine administration (Day 31) ]
    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

  8. RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [ Time Frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
    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) >=4.


Secondary Outcome Measures :
  1. Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) [ Time Frame: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1) ]
    Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.

  2. Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) [ Time Frame: During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1) ]
    Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever [temperature equal to or above (>=) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.

  3. Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1) ]
    Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

  4. Percentage of Participants Reporting Any Serious Adverse Events (SAEs) [ Time Frame: From the day of the vaccination (Day 1) up to 6 months post dose (Month 6) ]
    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, or results in an abnormal pregnancy outcome.

  5. Percentage of Participants Reporting Any Potential Immune Mediated Diseases (pIMDs) [ Time Frame: From the day of the vaccination (Day 1) up to 6 months post dose (Month 6) ]
    pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

  6. Percentage of Participants Reporting SAEs Related to Study Intervention Administration [ Time Frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1) ]
    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, or results in an abnormal pregnancy outcome.

  7. Percentage of Participants Reporting pIMDs Related to Study Intervention Administration [ Time Frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1) ]
    pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

  8. Percentage of Participants Reporting Any Fatal SAEs [ Time Frame: From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1) ]
    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, or results in an abnormal pregnancy outcome.

  9. RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention [ Time Frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31) ]
    Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA_RSV, Adults HA-Placebo, Adult AIR_RSV, Adult AIR_Placebo and OA_RSV groups.

  10. RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention [ Time Frame: At 6 months and at 12 months after study intervention administration ]
    Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.

  11. RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention [ Time Frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31) ]
    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA_RSV, Adults HA-Placebo, Adult AIR_RSV, Adult AIR_Placebo and OA_RSV groups.

  12. RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention [ Time Frame: At 6 months and at 12 months after study intervention administration ]
    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.

  13. Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention [ Time Frame: At pre-study intervention administration (Day 1) and 1 months after study intervention administration (Day 31) ]
    Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

  14. Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention [ Time Frame: At 6 months and at 12 months after study intervention administration ]
    Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

  15. Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention [ Time Frame: At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31) ]
    Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

  16. Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 [ Time Frame: At 6 months and at 12 months after study intervention administration ]
    Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
  • Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.

    1. Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group)

  • A male or female participant 50-59 YOA at the time of the study intervention administration.
  • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as 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 until study end for this study, and
    • has a negative pregnancy test on the day of study intervention administration.

Specific inclusion criteria for participants in the Adults-HA Sub-cohort

  • Healthy participants as established by medical history and clinical examination before entering into the study.
  • Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).

Specific inclusion criteria for participants in the Adults-AIR Sub cohort

Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):

  • Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
  • Chronic cardiovascular disease
  • Diabetes mellitus: types 1 and 2
  • Other diseases at increased risk for RSV-LRTD disease

    • Chronic kidney disease
    • Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)
  • 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 by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
  • 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 or immunosuppressive/cytotoxic therapy, 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.
  • Hypersensitivity to latex.
  • 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. 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.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

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 4, Month 12).
  • 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 and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration.

Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the 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 that the Sponsor is notified accordingly.

  • Previous vaccination with an 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 the study.

    • Up to 3 months prior to the study intervention administration:
    • For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. 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, 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.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05590403


Locations
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Sponsors and Collaborators
GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] May 30, 2023
Statistical Analysis Plan  [PDF] May 9, 2023

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05590403    
Other Study ID Numbers: 219238
2022-001981-36 ( EudraCT Number )
First Posted: October 21, 2022    Key Record Dates
Results First Posted: May 21, 2024
Last Update Posted: May 21, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by GlaxoSmithKline:
Respiratory syncytial virus
Immunogenicity
Safety
Increased risk of respiratory syncytial virus lower respiratory tract disease
Adults aged 50-59 years of age
Older adults 60 years of age and above
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Respiratory Tract Diseases
Virus Diseases
Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections