| Primary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 0 to Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine | 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From screening (up to 21 days prior to Month 0) until Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Fatal 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From screening (up to 21 days prior to Month 0) until Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Adverse Events (AEs) of Specific Interest | AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 0 until Month 18 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in. | Posted | | Count of Participants | | Participants | | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral/axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Unsolicited 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Within 30 days (Days 0-29) after each vaccination | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Screening Visit (up to 21 days prior to Month 0) | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Month 1 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Month 2 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Month 6 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Month 7 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects | In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 0 until Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any AIDS-defining Condition | In this analysis, results were tabulated for the main study groups. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 0 until Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count | In this analysis, results were tabulated for the main study groups. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 1 to Month 7 | | | | ID | Title | Description |
|---|
| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | In this analysis, results were tabulated by HIV status | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 0 to Month 18 | | | | ID | Title | Description |
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| OG000 | Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A | ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | ART High CD4 Cohort - Placebo | ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG002 | ART Low CD4 Cohort - GSK 1437173A | ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any AIDS-defining Condition, by HIV Status | In this analysis, results were tabulated by HIV status | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 0 to Month 18 | | | | ID | Title | Description |
|---|
| OG000 | Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A | ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | ART High CD4 Cohort - Placebo | ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG002 | ART Low CD4 Cohort - GSK 1437173A | ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | In this analysis, results were tabulated by HIV status. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 1 to Month 7 | | | | ID | Title | Description |
|---|
| OG000 | Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A | ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | ART High CD4 Cohort - Placebo | ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG002 | ART Low CD4 Cohort - GSK 1437173A | ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | Frequency of gE-specific CD4 T-cells | The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available at Month 7. | Posted | | Mean | Standard Deviation | CD4 T-cells/million T-cells | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Primary | -Anti-gE Antibody (Ab) Concentrations | -Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). | | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 7 | | | | ID | Title | Description |
|---|
| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Secondary | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups. | The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence). | Posted | | Mean | Standard Deviation | CD4 T-cells/million T-cells | | At Month 0, 1, 2, 3, 6, 7 and 18 | | | | ID | Title | Description |
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| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Secondary | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status. | The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence). | Posted | | Mean | Standard Deviation | CD4 T-cells/million T-cells | | At Months 0, 1, 2, 3, 6, 7 and 18 | | | | ID | Title | Description |
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| OG000 | Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A | ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | ART High CD4 Cohort - Placebo | ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG002 | ART Low CD4 Cohort - GSK 1437173A |
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| Secondary | -Anti-VZV and Anti-gE Antibody Concentrations | Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. | The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence). | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Months 0, 1, 2, 3, 6, 7 and 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Secondary | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. | The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence). | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Months 0, 1, 2, 3, 6, 7 and 18 | | | | ID | Title | Description |
|---|
| OG000 | Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A | ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | ART High CD4 Cohort - Placebo | ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG002 | ART Low CD4 Cohort - GSK 1437173A |
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| Secondary | Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications | | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 0 until Month 18 | | | | ID | Title | Description |
|---|
| OG000 | GSK1437173A Group | Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | Placebo Group | Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Secondary | CD4 Count | CD4 count was tabulated by HIV status. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Mean | Standard Deviation | CD4 T-cells/million T-cells | | At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18 | | | | ID | Title | Description |
|---|
| OG000 | Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A | ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | ART High CD4 Cohort - Placebo | ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG002 | ART Low CD4 Cohort - GSK 1437173A | ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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| Secondary | HIV VL | HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL. | The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL. | Posted | | Mean | Standard Deviation | HIV-RNA copies/mL | | At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18 | | | | ID | Title | Description |
|---|
| OG000 | Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A | ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG001 | ART High CD4 Cohort - Placebo | ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | | OG002 | ART Low CD4 Cohort - GSK 1437173A | ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. |
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