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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002702-78 | EudraCT Number |
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The purpose of this study is to evaluate the persistence of the vaccine induced immune responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in naturally infected subjects who participated in the screening visit of the primary study 108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value (seropositive reference group). In addition, this study will continue to assess the occurrence of CMV infections as well as the continued development and validation of read-outs in the CMV project.
The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting (NCT00435396).
During the long-term follow-up study, all subjects who received 3 doses of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890 (NCT00435396) will be invited to participate at Visit 8 (Year 4) and Visit 9 (Year 5) as the vaccine group. In addition, the healthy subjects who participated in the screening visit of the primary study 108890 (NCT00435396) and who were tested CMV-seropositive will be invited to Visit 9 (Year 5) of this study as the seropositive reference group.This Protocol Posting has been updated following Protocol Amendment 1, March 2012, leading to the update of brief summary, intervention model, enrolment, outcome measures, eligibility and arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK149203A S- Group | Experimental | Male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396). |
|
| GSK149203A S+ Group | Other | Male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood samples will be collected at 2 time points: At the long-term follow-up at approximately Month 48 of study (= ± 42 months post dose 3) from all subjects in the vaccine group. At the long-term follow-up at approximately Month 60 of study (= ± 54 months post dose 3) from all subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG) | Anti-gB IgG antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL), as assessed by Enzyme-linked Immunosorbent Assay (ELISA). Data were collected at Month 48 (M48) and Month 60 (M60) from all subjects. | At Month 48 and Month 60 |
| Number of Subjects With Neutralizing Response Against Anti-Cytomegalovirus (CMV) Antibodies | The neutralizing antibodies were to be measured using an in-house micro-neutralization assay. | At Month 48 and Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies | Avidity for anti-gB IgG antibodies was assessed by the ELISA Avidity index method in all subjects, at Month 48 (M48) and Month 60 (M60). This assay has been developed according to Souza et al (Rev.Inst.med.Trop.S.Paulo 45;323-326; 2003) using an elution step with urea to remove low-avidity antibodies from CMV antigen. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes are exposed to urea divided by the mean absorbance of reactions in which the immune complexes are not exposed to urea, expressed as a percentage. |
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Inclusion Criteria:
Subjects of the vaccine group should in addition satisfy the following criterion:
• Subjects who participated in the primary study 108890 (NCT00435396), having received 3 doses of the GSK's CMV candidate vaccine and having completed the Year 2 follow-up study 109211 (NCT00435396).
Subjects of the seropositive reference group should in addition satisfy the following criterion:
• Subjects who participated in the screening visit of the primary study 108890 (NCT00435396), and whose blood sample taken at this visit was tested CMV positive.
Exclusion Criteria:
For subjects in the vaccine group, the following exclusion criterion should be checked in addition:
• Administration of any additional CMV vaccine since end of primary study 108890 (NCT00435396).
For subjects in the seropositive reference group, the following exclusion criterion should be checked in addition:
• Administration of any CMV vaccine since the screening visit of primary study 108890 (NCT00435396).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | La Louvière | 7100 | Belgium | |||
| GSK Investigational Site |
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Subjects from the GSK149203A S+ Group participated only in the Month 60 time point of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK149203A S- Group | Healthy male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396). |
| FG001 | GSK149203A S+ Group | Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK149203A S- Group | Healthy male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396). |
| BG001 | GSK149203A S+ Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG) | Anti-gB IgG antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL), as assessed by Enzyme-linked Immunosorbent Assay (ELISA). Data were collected at Month 48 (M48) and Month 60 (M60) from all subjects. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 48 and Month 60 |
|
Serious Adverse Events (SAEs) and other adverse events: during the entire study period (from Month 48 up to Month 60) there were no SAEs or other significant AEs reported in the study.
Other (non-serious) Adverse Events were not collected in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK149203A S- Group | Healthy male subjects who received 3 doses of GSK Biologicals' candidate GSK149203A vaccine according to a 0-1-6 month schedule in the primary study 108890 (NCT00435396). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| GSK149203A | Biological | GSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses |
|
| At Month 48 and Month 60 |
| Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers | Among the immune markers determined by the Intracellular cytokine staining (ICS) were Interferon-gamma (INF-γ), Interleukin-2 (IL-2), Tumor necrosis factor-alpha (TNF-α), and CD40-Ligand (CD40-L). Data were collected for all subjects at Month 48 (M48) and Month 60 (M60). | At Month 48 and Month 60 |
| Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT) | Memory B cells specific to the CMV gB antigen, as assessed by the Enzyme-linked Immunosorbent Spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60). | At Month 48 and Month 60 |
| Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies | CMV infection was determined by the anti-CMV proteins antibody response, using ELISA. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60) in the Vaccine group (GSK149203A S- Group). All subjects from the Reference group (GSK149203A S+ Group) were positive for the anti-CMV tegument IgG antibodies at the screening visit. | At Month 48 and Month 60 |
| Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Viral Load | CMV DNA viral loads were assessed using quantitative Polymerase Chain Reaction (qPCR). Data were presented for subjects included in the Vaccine group (GSK149203A S- Group). | At Month 48 and Month 60 |
| Wilrijk |
| 2610 |
| Belgium |
Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG001 | GSK149203A S+ Group | Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396). |
|
|
| Primary | Number of Subjects With Neutralizing Response Against Anti-Cytomegalovirus (CMV) Antibodies | The neutralizing antibodies were to be measured using an in-house micro-neutralization assay. | The persistence of the functional antibodies for Month 48 and Month 60 could not be analysed, due to the general deterioration of CMV-001/CMV-008 samples. | Posted | At Month 48 and Month 60 |
|
|
| Secondary | Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies | Avidity for anti-gB IgG antibodies was assessed by the ELISA Avidity index method in all subjects, at Month 48 (M48) and Month 60 (M60). This assay has been developed according to Souza et al (Rev.Inst.med.Trop.S.Paulo 45;323-326; 2003) using an elution step with urea to remove low-avidity antibodies from CMV antigen. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes are exposed to urea divided by the mean absorbance of reactions in which the immune complexes are not exposed to urea, expressed as a percentage. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | Avidity Index percentage | At Month 48 and Month 60 |
|
|
|
| Secondary | Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers | Among the immune markers determined by the Intracellular cytokine staining (ICS) were Interferon-gamma (INF-γ), Interleukin-2 (IL-2), Tumor necrosis factor-alpha (TNF-α), and CD40-Ligand (CD40-L). Data were collected for all subjects at Month 48 (M48) and Month 60 (M60). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | T cells/million cells | At Month 48 and Month 60 |
|
|
|
| Secondary | Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT) | Memory B cells specific to the CMV gB antigen, as assessed by the Enzyme-linked Immunosorbent Spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Inter-Quartile Range | B cells/million cells | At Month 48 and Month 60 |
|
|
|
| Secondary | Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies | CMV infection was determined by the anti-CMV proteins antibody response, using ELISA. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60) in the Vaccine group (GSK149203A S- Group). All subjects from the Reference group (GSK149203A S+ Group) were positive for the anti-CMV tegument IgG antibodies at the screening visit. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Month 48 and Month 60 |
|
|
|
| Secondary | Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Viral Load | CMV DNA viral loads were assessed using quantitative Polymerase Chain Reaction (qPCR). Data were presented for subjects included in the Vaccine group (GSK149203A S- Group). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Month 48 and Month 60 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 0 |
| EG001 | GSK149203A S+ Group | Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396). | 0 | 17 | 0 | 17 | 0 | 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Anti-gB IgG, M60 |
|
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| CD4-All doubles, M60 |
|
|
| CD8-All doubles, M48 |
|
|
| CD8-All doubles, M60 |
|
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| Memory B-cells, M60 |
|
|
| Title | Measurements |
|---|---|
|
| Positive anti-CMV antibodies, M60 |
|
| Negative anti-CMV antibodies, M60 |
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| Missing anti-CMV antibodies, M60 |
|