The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.
The Protocol Posting has been updated following Protocol amendment 2, Sep 2009. The sections impacted are: eligibility criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
121
Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.
1 or 3 doses of Placebo (saline) injected intramuscularly.
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Duarte, California, United States
GSK Investigational Site
San Francisco, California, United States
Number of Subjects With Any and Grade 3 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 that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[including nausea, vomiting, diarrhoea and abdominal pain\], temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (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.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Minneota, Minnesota, United States
GSK Investigational Site
Rochester, Minnesota, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Durham, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
...and 1 more locations
Time frame: Any time during the study up to Day 29 after the last vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Day 0 up to Month 15)
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Time frame: Within the 30-day (Days 0-29) post last vaccination period
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Time frame: During the entire study period (from Day 0 to Month 15)
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 0
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 1
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 2
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 3
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Time frame: At Month 4
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \[IFN-γ\], Interleukin 2 \[IL-2\], Tumour Necrosis Factor alpha \[TNF-α\] and/or CD40 Ligand \[CD40L\] as determined by in vitro intracellular cytokine staining (ICS).
Time frame: At Month 4
Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Month 4
Anti-gE Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Month 4
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \[IFN-γ\], Interleukin 2 \[IL-2\], Tumour Necrosis Factor alpha \[TNF-α\] and/or CD40 Ligand \[CD40L\] as determined by in vitro intracellular cytokine staining (ICS).
Time frame: At Months 0, 1, 2, 3, 4 and 15
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \[IFN-γ\], Interleukin 2 \[IL-2\], Tumour Necrosis Factor alpha \[TNF-α\] and/or CD40 Ligand \[CD40L\] as determined by in vitro intracellular cytokine staining (ICS).
Time frame: At Months 0, 1, 2, 3 and 15
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Months 0, 1, 2, 3, 4 and 15
VZV-specific Mean Antibody Concentrations
Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Months 0, 1, 2, 3, 4 and 15
Anti-gE Geometric Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Months 0, 1, 2, 3 and 15
Anti-gE Mean Antibody Concentrations
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Months 0, 1, 2, 3 and 15
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as 'a confirmed case of HZ' or 'not a case of HZ' based on the determination by the GSK responsible physician of the study.
Time frame: During the entire study period (from Day 0 to Month 15)