Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Phase 3Active Not RecruitingNCT04732871

GlaxoSmithKline1,720 enrolled

Overview

The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,720

Conditions

Respiratory Syncytial Virus Infections

Interventions

RSVPreF3 OA investigational vaccineBIOLOGICAL

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants). * 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. * Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients 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. 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. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Serious or unstable chronic illness. * Recurrent or un-controlled 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. * 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. * Any history of dementia or any medical condition that moderately or severely impairs cognition. Prior/Concomitant therapy * Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. * Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination. * Previous vaccination with an RSV vaccine. * Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period. * Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone \>=20 mg/day, or equivalent. Inhaled and topical steroids are allowed. 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. Other exclusions * 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 participation in the trial until the study end. This includes: * Planned move during the study period to another LTCF that will prohibit participation in the trial until study end. * Planned move from the community to a LTCF that will prohibit participation in the trial until study end. * Participation of any study personnel or their immediate dependants, family, or household members.

Locations (46)

Outcomes

Primary Outcomes

Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1

RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Day 1

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Time frame: At Day 31

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Time frame: At Month 6

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Time frame: At Month 12

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Time frame: At Day 1

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Time frame: At Day 31

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Time frame: At Month 6

Data from ClinicalTrials.gov

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Secondary Outcomes

Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC was expressed in Elisa Laboratory Units/milliliter (ELU/mL).

Time frame: At Day 1

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Day 31

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 6

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 12

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18

Month 18 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 18

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24

Month 24 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 24

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30

Month 30 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 30

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36

Month 36 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 36

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13

Month 13 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 13

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25

Month 25 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 25

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18

Month 18 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 18

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24

Month 24 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 24

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30

Month 30 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 30

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36

Month 36 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 36

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13

Month 13 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 13

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25

Month 25 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Time frame: At Month 25

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18

Month 18 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 18

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24

Month 24 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 24

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30

Month 30 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 30

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36

Month 36 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 36

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13

Month 13 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 13

Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25

Month 25 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Time frame: At Month 25

Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1

Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Time frame: At Day 1

CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1