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A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults

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ClinicalTrials.gov Identifier: NCT04090658
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase I, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK's Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Japanese Subjects Aged 60-80 Years
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : January 27, 2020
Estimated Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group RSV_PreF3_AS01B
Subjects aged 60 to 80 years receiving 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Days 1 and 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.
Biological: RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the non-dominant arm preferably.

Placebo Comparator: Group Placebo
Subjects aged 60 to 80 years receiving 2 doses of placebo as control, at Days 1 and 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Drug: Placebo
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the non-dominant arm preferably.




Primary Outcome Measures :
  1. Number of subjects with solicited local adverse events (AEs) after first dose of vaccination [ Time Frame: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination ]
    Assessed solicited local AEs are: Pain at injection site; Redness at injection site and Swelling at injection site. Any redness/swelling is scored as injection site redness/swelling with a diameter larger than (>) 20 millimeters (mm).

  2. Number of subjects with solicited local adverse events (AEs) after second dose of vaccination [ Time Frame: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination ]
    Assessed solicited local AEs are: Pain at injection site; Redness at injection site and Swelling at injection site. Any redness/swelling is scored as injection site redness/swelling with a diameter larger than (>) 20 millimeters (mm).

  3. Number of subjects with solicited general AEs after first dose of vaccination [ Time Frame: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination ]
    Assessed solicited general AEs solicited are: Fatigue; Fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); Gastrointestinal symptoms including nausea, vomiting, diarrhea and/or abdominal pain; Headache; Myalgia; Shivering and Arthralgia.

  4. Number of subjects with solicited general AEs after second dose of vaccination [ Time Frame: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination ]
    Assessed solicited general AEs solicited are: Fatigue; Fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); Gastrointestinal symptoms including nausea, vomiting, diarrhea and/or abdominal pain; Headache; Myalgia; Shivering and Arthralgia.

  5. Number of subjects with unsolicited AEs after first dose of vaccination [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after first dose of vaccination ]
    An unsolicited AE is 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 is to be reported as an unsolicited AE.

  6. Number of subjects with unsolicited AEs after second dose of vaccination [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after second dose of vaccination ]
    An unsolicited AE is 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 is to be reported as an unsolicited AE.

  7. Number of subjects presenting hematological and biochemical abnormalities after first vaccine dose when compared to Day 1 [ Time Frame: At 7 days after the first vaccine dose (Day 8) ]
    Assessed hematological laboratory parameters include erythrocytes, white blood cells [WBC] and differential count, platelets count and hemoglobin level. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, blood urea nitrogen [BUN] and uric acid., Abnormalities reported when comparing Day 1 (pre-vaccination dose 1) and Day 8 haematological and biochemical laboratory results are tabulated.

  8. Number of subjects presenting hematological and biochemical abnormalities after second vaccine dose, when compared to Day 61 [ Time Frame: At 7 days after the second vaccine dose (Day 68) ]
    Assessed hematological laboratory parameters include erythrocytes, white blood cells [WBC] and differential count, platelets count and hemoglobin level. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, blood urea nitrogen [BUN] and uric acid., Abnormalities reported when comparing Day 61 (pre-vaccination dose 2) and Day 68 haematological and biochemical laboratory results are tabulated.

  9. Number of subjects presenting hematological and biochemical abnormalities after second vaccine dose, when compared to Day 1 [ Time Frame: At 67 days after the first vaccine dose (Day 68) ]
    Assessed hematological laboratory parameters include erythrocytes, white blood cells [WBC] and differential count, platelets count and hemoglobin level. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, blood urea nitrogen [BUN] and uric acid., Abnormalities reported when comparing Day 1 (pre-vaccination dose 1) and Day 68 haematological and biochemical laboratory results are tabulated.

  10. Number of subjects with any Grade 3 non-serious AEs (solicited and unsolicited) after first dose of vaccination [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after first dose of vaccination ]
    A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.

  11. Number of subjects with any Grade 3 non-serious AEs (solicited and unsolicited) after second dose of vaccination [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after second dose of vaccination ]
    A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.

  12. Number of subjects with any Serious Adverse Events (SAEs) up to 30 days after the second vaccination [ Time Frame: From Day 1 up to 30 days after the second vaccination (Day 91) ]
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

  13. Number of subjects with any potential immune-mediated diseases (pIMDs) up to 30 days after the second vaccination [ Time Frame: From Day 1 up to 30 days after the second vaccination (Day 91) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.


Secondary Outcome Measures :
  1. Humoral immune response with respect to components of the investigational vaccine in terms of neutralizing antibody titers against RSV-A [ Time Frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91) ]
    Serological assays for the determination of functional antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers are expressed in Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60). The cut-off value will be defined in the statistical analysis plan.

  2. Humoral immune response with respect to components of the investigational vaccine in terms of RSVPreF3-specific Immunoglobulin G (IgG) antibody concentrations [ Time Frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91) ]
    The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples are based on an indirect enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentration, is expressed in arbitrary ELISA Laboratory Units per milliliter (ELU/mL). The cut-off value will be defined in the statistical analysis plan.

  3. Number of subjects with any SAEs, up the end of follow-up (Month 14) [ Time Frame: From Day 1 up to the end of follow-up (Month 14) ]
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

  4. Number of subjects reporting pIMDs up to the end of follow-up (Month 14) [ Time Frame: From Day 1 up to the end of follow-up (Month 14) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

  5. Number of subjects with RSV-associated respiratory tract infection (RTI) in the combined nasal and throat swabs collected during the assessment visit for potential RSV-RTI during the RSV seasons, up to the end of follow-up [ Time Frame: During the RSV seasons from Day 1 to Month 14 ]
    For identified RTI cases under active or passive surveillance, the potential RSV infection is assessed and confirmed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) testing of swabs. The results are expressed in Copies/milliliter (copies/mL).



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject prior to performance of any study specific procedure.
  • A male or female between, and including, 60 and 80 years of age at the time of the first vaccination.
  • Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living, may be enrolled.
  • Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese).
  • Subject satisfying screening requirements.

Exclusion Criteria:

Medical conditions

  • Any medical condition that in the judgment of the investigator would make IM injection unsafe.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, 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 vaccine.
  • Hypersensitivity to latex.
  • Serious or unstable chronic illness. Patients with chronic stable conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
  • History of any neurological disorders or seizures.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by the investigator based on medical history, physical examination or laboratory screening tests.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  • Lymphoproliferative disorder and malignancy within 5 years.
  • At screening: Hematology parameters (complete blood cell count [red blood cells, WBC], white blood cells differential count [lymphocytes, neutrophils and eosinophils], platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood urea nitrogen or liver enzymes [ALT or AST]) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after each study vaccination.
  • Previous vaccination with an RSV vaccine.
  • Known previous administration of a vaccine containing MPL, QS-21 and/or MF59.
  • Planned administration of GSK's Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su] within 180 days after the second dose of the study vaccine.
  • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
  • 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 during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).

Other exclusions

  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Body mass index greater than 40 kg/m^2.
  • Planned move to a location that will prohibit participating in the trial until study end.
  • Bedridden subjects.

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): NCT04090658


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Japan
GSK Investigational Site Recruiting
Fukuoka, Japan, 812-0025
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Miwa Haranaka         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04090658     History of Changes
Other Study ID Numbers: 209699
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
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 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
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs