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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01357915
First received: May 12, 2011
Last updated: September 27, 2012
Last verified: September 2012
  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 Phase
Cytomegalovirus
Procedure: Blood sampling
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-Glycoprotein B (anti-gB) antibody concentrations by enzyme-linked immunosorbent assay (ELISA) in all subjects [ Time Frame: Month 48 and Month 60 ] [ Designated as safety issue: No ]
    Month 48 for all subjects of vaccine group. Month 60 for all subjects.

  • Neutralizing anti-CMV antibody response (measured by neutralization assay) in all subjects [ Time Frame: Month 48 and Month 60 ] [ Designated as safety issue: No ]
    Month 48 for all subjects of vaccine group. Month 60 for all subjects.


Secondary Outcome Measures:
  • Anti-gB antibody avidity by ELISA in all subjects [ Time Frame: Month 48 and Month 60 ] [ Designated as safety issue: No ]
    Month 48 for all subjects of vaccine group. Month 60 for all subjects.

  • Frequencies of gB-specific CD4+/CD8+ T-cells expressing Interferon gamma and/or Interleukin-2 and/or Tumor Necrosis Factor alpha and/or Cluster of Differentiation 40L as determined by intracellular cytokine staining in all subjects [ Time Frame: Month 48 and Month 60 ] [ Designated as safety issue: No ]
    Month 48 for all subjects of vaccine group. Month 60 for all subjects.

  • To evaluate the gB-specific memory B cell response by Enzyme-linked immunosorbent spot (ELISPOT) in all subjects [ Time Frame: Month 48 and Month 60 ] [ Designated as safety issue: No ]
    Month 48 for all subjects of vaccine group. Month 60 for all subjects.

  • Anti-CMV tegument proteins antibody response in all subjects in the vaccine group [ Time Frame: Month 48 and Month 60 ] [ Designated as safety issue: No ]
    For all subjects of vaccine group.

  • CMV DNA in blood by using quantitative Polymerase Chain Reaction (PCR) in all subjects in the vaccine group [ Time Frame: Month 48 and Month 60 ] [ Designated as safety issue: No ]
    For all subjects of vaccine group.


Enrollment: 47
Study Start Date: June 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine group
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).
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.
Seropositive reference group
Healthy subjects who participated in the screening visit of the primary study 108890 (NCT00435396) and who were tested CMV-seropositive.
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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01357915     History of Changes
Other Study ID Numbers: 115429, 2011-002702-78
Study First Received: May 12, 2011
Last Updated: September 27, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:
Cytomegalovirus
Vaccine

ClinicalTrials.gov processed this record on September 18, 2014