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Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357915
First Posted: May 23, 2011
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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).


Condition Intervention
Infections, Cytomegalovirus Procedure: Blood sampling Biological: GSK149203A

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Concentrations of Antibodies Against Anti-gB 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-CMV Antibodies [ Time Frame: At Month 48 and Month 60 ]

Secondary Outcome Measures:
  • Avidity Towards Anti-gB IgG Antibodies [ Time Frame: At Month 48 and Month 60 ]
    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).

  • 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 ]
    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).

  • Specific B Cell Memory Immune Response for gB [ Time Frame: At Month 48 and Month 60 ]
    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).

  • Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies [ Time Frame: At Month 48 and Month 60 ]
    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.

  • Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Blood [ Time Frame: At Month 48 and Month 60 ]

Enrollment: 47
Actual Study Start Date: June 24, 2011
Study Completion Date: September 13, 2012
Primary Completion Date: September 13, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK149203A S- Group
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).
Procedure: Blood sampling

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.

Biological: GSK149203A
GSK Biologicals' Recombinant CMV glicoprotein B Vaccine, Intramuscular injection, 3 doses
GSK149203A S+ Group
Male subjects who were assessed as being naturally infected with Cytomegalovirus (CMV) at the screening visit of the primary study 108890 (NCT00435396).
Procedure: Blood sampling

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.


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357915


Locations
Belgium
GSK Investigational Site
La Louvière, Belgium, 7100
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01357915     History of Changes
Other Study ID Numbers: 115429
2011-002702-78 ( EudraCT Number )
First Submitted: May 12, 2011
First Posted: May 23, 2011
Results First Submitted: May 12, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
Cytomegalovirus
Vaccine

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs