Infections, CytomegalovirusNCT01357915
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine
A study testing Blood sampling and GSK149203A in people with Infections, Cytomegalovirus, run by GlaxoSmithKline at 2 sites in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Cytomegalovirus
- What is being tested?
- Blood sampling and GSK149203A
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesBelgium
- Study dates
- 24 Jun 2011to 13 Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study.
- Written informed consent obtained from the subject.
- Healthy subjects as established by clinical evaluation (medical history and physical examination) before entering in the study.
- 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.
Who cannot join
- Use, or planned use, of any investigational or non-registered product (drug or vaccine) during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study visit(s). For corticosteroids, this will mean prednisone, 20mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within three months preceding study visit(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- 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).
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
GSK Investigational Site
La Louvière, 7100
GSK Investigational Site
Wilrijk, 2610
About this study
Official title: A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults
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).
Read the detailed description
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.
- Conditions
- Infections, Cytomegalovirus
- Being tested
- Blood sampling, GSK149203A
- Keywords
- Cytomegalovirus, Vaccine
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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.
GSK149203ABiological
GSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Blood sampling; Biological: GSK149203A |
| 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). Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Month 48 and Month 60
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: At Month 48 and Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study start24 Jun 2011
- Primary completion13 Sep 2012
- Study completion13 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infections, CytomegalovirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357915
- Sponsor's protocol ID
- 115429
- Other IDs
- 2011-002702-78
- Status last verified
- Dec 2019
- First submitted
- 12 May 2011
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults
- ClinicalTrials.gov ID
- NCT01357915
- Acronym / sponsor ID
- 115429
- Conditions
- Infections, Cytomegalovirus
- Keywords
- Cytomegalovirus, Vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2011 (actual)
- Primary completion
- 13 Sep 2012 (actual)
- Study completion
- 13 Sep 2012 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK149203A S- Group | Experimental | Procedure: Blood sampling, Biological: GSK149203AMale 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 | Procedure: Blood samplingMale subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study.
- Written informed consent obtained from the subject.
- Healthy subjects as established by clinical evaluation (medical history and physical examination) before entering in the study.
- 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:
Key exclusion criteria (8 listed)
- Use, or planned use, of any investigational or non-registered product (drug or vaccine) during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study visit(s). For corticosteroids, this will mean prednisone, 20mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within three months preceding study visit(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- For subjects in the vaccine group, the following exclusion criterion should be checked in addition:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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. | Procedure or surgery | GSK149203A S+ Group, GSK149203A S- Group |
| GSK149203AGSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses | Biological | GSK149203A S- Group |
Primary outcome
Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG)
Time frame: At Month 48 and Month 60
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.
Number of Subjects With Neutralizing Response Against Anti-Cytomegalovirus (CMV) Antibodies
Time frame: At Month 48 and Month 60
The neutralizing antibodies were to be measured using an in-house micro-neutralization assay.
5 secondary outcomes
Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies
Time frame: 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
Time frame: At Month 48 and Month 60
Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT)
Time frame: At Month 48 and Month 60
Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
Time frame: At Month 48 and Month 60
Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Viral Load
Time frame: At Month 48 and Month 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and GSK149203A in people with Infections, Cytomegalovirus, run by GlaxoSmithKline at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG) (time frame: At Month 48 and Month 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.