The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
265
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter \[mIU/ml\]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Time frame: At Month 2.
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Pain when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within 7 days (Days 0-6) after each dose and across doses.
Days With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling.
Time frame: Within 7 days (Days 0-6) after each dose and overall/dose
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain.
Time frame: Within 7 days (Days 0-6) after each dose and across doses
Days With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\].
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GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Helsinki, Finland
...and 24 more locations
Time frame: Within 7 days (Days 0-6) after each dose and overall/dose
Number of Subjects With Unsolicited Symptoms (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
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 aetiology
Time frame: From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Time frame: From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Number of Subjects With Renal Allograft Rejection
Renal allograft rejection was confirmed through biopsy.
Time frame: From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Number of Subjects With Changes in Allograft Function
Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented.
Time frame: From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Anti-gE Antibody Concentrations
Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL.
Time frame: At Months 0, 1, 2, 7 and 13
Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by ELISA.
Time frame: At Months 1, 7 and 13
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma \[IFN-γ\], interleukin-2 \[IL-2\], tumour necrosis factor alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40L\]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: At Months 0, 2 and 13
Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells
Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x\<320\> Events/10 million CD4+ T-cells); For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.
Time frame: At Months 2 and 13
Number of Subjects With Any and Related SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13).
Number of Subjects With Any pIMDs
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 aetiology.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13).
Number of Subjects With Renal Allograft Rejection
Renal allograft rejection was confirmed through biopsy.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13).
Number of Subjects With Changes in Allograft Function
Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13)