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

NCT01357915 | Completed Results

• 2 other identifiers: 1154292011-002702-78
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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).

Conditions

Infections, Cytomegalovirus

Keywords

Cytomegalovirus; Vaccine

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At Month 48 and Month 60

Secondary Outcomes (5)

• Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies

  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

  At Month 48 and Month 60

• Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT)

  At Month 48 and Month 60

• Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies

  At Month 48 and Month 60

• Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Viral Load

  At Month 48 and Month 60

Study Arms (2)

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).

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).

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

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.

GSK149203A S+ Group; GSK149203A S- Group

GSK149203A BIOLOGICAL

GSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses

GSK149203A S- Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Administration of any additional CMV vaccine since end of primary study 108890 (NCT00435396).
• Administration of any CMV vaccine since the screening visit of primary study 108890 (NCT00435396).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

La Louvière, 7100, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 23, 2011
• Study Start: June 24, 2011
• Primary Completion: September 13, 2012
• Study Completion: September 13, 2012
• Last Updated: January 13, 2020
• Results First Posted: October 6, 2017

Record last verified: 2019-12

Locations

BE (2)