Clinical trial NCT01357915: Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine
Official title: A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Cytomegalovirus
Keywords: Cytomegalovirus
Vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility 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).

Primary outcomes:
measure: Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG)
timeFrame: At Month 48 and Month 60
measure: Number of Subjects With Neutralizing Response Against Anti-Cytomegalovirus (CMV) Antibodies
timeFrame: At Month 48 and Month 60
Secondary outcomes:
measure: Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies
timeFrame: At Month 48 and Month 60
measure: Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers
timeFrame: At Month 48 and Month 60
measure: Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT)
timeFrame: At Month 48 and Month 60
measure: Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies
timeFrame: At Month 48 and Month 60
measure: Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Viral Load
timeFrame: At Month 48 and Month 60
Other outcomes:
Locations:
city: La Louvière
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: