Trial Outcomes & Findings for Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine (NCT NCT01357915)
NCT ID: NCT01357915
Last Updated: 2020-01-13
Results Overview
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.
COMPLETED
NA
47 participants
At Month 48 and Month 60
2020-01-13
Participant Flow
Subjects from the GSK149203A S+ Group participated only in the Month 60 time point of the study.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
17
|
|
Overall Study
COMPLETED
|
27
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine
Baseline characteristics by cohort
| Measure |
GSK149203A S- Group
n=30 Participants
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).
|
GSK149203A S+ Group
n=17 Participants
Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
35.5 Years
STANDARD_DEVIATION 7.20 • n=7 Participants
|
34.73 Years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
30 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other: unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 48 and Month 60Population: 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.
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.
Outcome measures
| Measure |
GSK149203A S- Group
n=27 Participants
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).
|
GSK149203A S+ Group
n=16 Participants
Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
|
|---|---|---|
|
Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG)
Anti-gB IgG, M48
|
5091.4 EL.U/mL
Interval 3463.2 to 7485.1
|
—
|
|
Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG)
Anti-gB IgG, M60
|
5495.1 EL.U/mL
Interval 3594.7 to 8400.1
|
2587.2 EL.U/mL
Interval 1745.6 to 3834.5
|
PRIMARY outcome
Timeframe: At Month 48 and Month 60Population: 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.
The neutralizing antibodies were to be measured using an in-house micro-neutralization assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Month 48 and Month 60Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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.
Outcome measures
| Measure |
GSK149203A S- Group
n=27 Participants
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).
|
GSK149203A S+ Group
n=16 Participants
Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
|
|---|---|---|
|
Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies
Anti-gB IgG, M48
|
74 Avidity Index percentage
Interval 70.0 to 76.0
|
—
|
|
Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies
Anti-gB IgG, M60
|
68 Avidity Index percentage
Interval 65.0 to 71.0
|
76 Avidity Index percentage
Interval 71.5 to 82.5
|
SECONDARY outcome
Timeframe: At Month 48 and Month 60Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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).
Outcome measures
| Measure |
GSK149203A S- Group
n=26 Participants
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).
|
GSK149203A S+ Group
n=15 Participants
Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
|
|---|---|---|
|
Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers
CD4-All doubles, M48
|
2169.00 T cells/million cells
Interval 1391.0 to 4290.0
|
—
|
|
Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers
CD4-All doubles, M60
|
1893.50 T cells/million cells
Interval 1070.0 to 3267.0
|
380.00 T cells/million cells
Interval 91.0 to 1704.0
|
|
Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers
CD8-All doubles, M48
|
91.00 T cells/million cells
Interval 1.0 to 173.0
|
—
|
|
Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers
CD8-All doubles, M60
|
104.00 T cells/million cells
Interval 24.0 to 287.0
|
81.00 T cells/million cells
Interval 2.0 to 321.0
|
SECONDARY outcome
Timeframe: At Month 48 and Month 60Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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).
Outcome measures
| Measure |
GSK149203A S- Group
n=27 Participants
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).
|
GSK149203A S+ Group
n=16 Participants
Healthy male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
|
|---|---|---|
|
Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT)
Memory B-cells, M48
|
3158.00 B cells/million cells
Interval 1467.0 to 7419.0
|
—
|
|
Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT)
Memory B-cells, M60
|
5784.00 B cells/million cells
Interval 4374.0 to 7240.0
|
210.50 B cells/million cells
Interval 46.0 to 676.5
|
SECONDARY outcome
Timeframe: At Month 48 and Month 60Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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.
Outcome measures
| Measure |
GSK149203A S- Group
n=30 Participants
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).
|
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).
|
|---|---|---|
|
Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
Positive anti-CMV antibodies, M48
|
0 Participants
|
—
|
|
Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
Negative anti-CMV antibodies, M48
|
26 Participants
|
—
|
|
Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
Missing anti-CMV antibodies, M48
|
4 Participants
|
—
|
|
Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
Positive anti-CMV antibodies, M60
|
2 Participants
|
—
|
|
Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
Negative anti-CMV antibodies, M60
|
25 Participants
|
—
|
|
Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
Missing anti-CMV antibodies, M60
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 48 and Month 60Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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).
Outcome measures
| Measure |
GSK149203A S- Group
n=30 Participants
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).
|
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).
|
|---|---|---|
|
Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Viral Load
|
NA Participants
In the vaccine group, at Month 48 and Month 60 after the first vaccination, none of the subjects assessed had CMV DNA detected in blood (by qPCR), the values were under 200.
|
—
|
Adverse Events
GSK149203A S- Group
GSK149203A S+ Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER