Phase 1
N=40
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT04090658 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Feb 2022
Primary outcome: Primary: Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination — 1; 0; 17; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination |
1; 0; 17; 1; 2; 0 | — |
| PRIMARY Number of Subjects With Solicited Local AEs After Second Dose of Vaccination |
0; 0; 17; 4; 0; 0 | — |
| PRIMARY Number of Subjects With Solicited General AEs After First Dose of Vaccination |
1; 0; 9; 2; 0; 0 | — |
| PRIMARY Number of Subjects With Solicited General AEs After Second Dose of Vaccination |
5; 0; 9; 1; 4; 0 | — |
| PRIMARY Number of Subjects With Unsolicited AEs After Any Vaccination |
7; 6 | — |
| PRIMARY Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 |
1; 0; 19; 20; 0; 1 | — |
| PRIMARY Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 |
20; 20; 0; 1; 20; 19 | — |
| PRIMARY Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination |
2; 0; 1; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination |
0; 1 | — |
| PRIMARY Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination |
0; 0 | — |
| SECONDARY Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A |
727.3; 656; 5315; 582.3; 4382.8; 646.1 | — |
| SECONDARY Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations |
6676.7; 7090.2; 85282.4; 7242.6; 54076.9; 5625.9 | — |
| SECONDARY Number of Subjects With Any SAEs, up the End of Follow-up Study Period (Month 14) |
0; 1 | — |
| SECONDARY Number of Subjects Reporting pIMDs up to the End of Follow-up Study Period (Month 14) |
0; 0 | — |
| SECONDARY Number of Subjects With Respiratory Tract Infection (RTI) Episodes Reported During RTI Surveillance |
0; 0; 1; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04090658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.