Last updated: 12/19/2019 12:10:15
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals’ Candidate Cytomegalovirus (CMV) Vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A follow-up study to evaluate the long-term persistence of GSK Biologicals’ candidate CMV vaccine administered to male adults
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Concentrations of antibodies against anti-Glycoprotein B (gB) Immunoglobulin G (IgG)
Timeframe: At Month 48 and Month 60
Number of subjects with neutralizing response against anti-Cytomegalovirus (CMV) antibodies
Timeframe: At Month 48 and Month 60
Secondary outcomes:
Descriptive statistics on avidity index (%) of anti-gB IgG antibodies
Timeframe: 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
Timeframe: At Month 48 and Month 60
Desciptive statistics on the frequency of gB-specific memory B-cells (by ELISPOT)
Timeframe: At Month 48 and Month 60
Number of subjects with response for anti-CMV tegument IgG antibodies
Timeframe: At Month 48 and Month 60
Assessment of CMV infection by CMV specific desoxyribonucleic acid (DNA) in viral load
Timeframe: At Month 48 and Month 60
Interventions:
Enrollment:
47
Primary completion date:
2012-13-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Cytomegalovirus
Product
GSK1492903A
Collaborators
Not applicable
Study date(s)
June 2011 to September 2012
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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).
Use, or planned use, of any investigational or non-registered product (drug or vaccine) during the study period.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2012-13-09
Actual study completion date
2012-13-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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