Last updated: 07/17/2024 15:20:04
Immunogenicity and safety study of GSK Biologicals’ herpes zoster vaccine with various formulations in adults >= 50 years
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity and safety study of different formulations of GSK Biologicals’ herpes zoster vaccine 1437173A when administered twice in adults aged 50 years and older
Trial description: The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Frequency of gE-specific cluster of differentiation 4 (CD4+) T-cells expressing at least 2 different immunological activation markers
Timeframe: One month after the second vaccination (Month 3)
Frequency of Varicella-Zoster Virus (VZV)-specific CD4+ T-cells expressing at least 2 different immunological activation markers
Timeframe: One month after the second vaccination (Month 3)
Anti-glycoprotein E (gE) antibody concentrations
Timeframe: One month after the second vaccination (Month 3)
Anti-VZV antibody concentrations
Timeframe: One month after the second vaccination (Month 3)
Secondary outcomes:
Frequencies of gE-specific CD4+ T-cells expressing at least 2 different immunological activation markers
Timeframe: At Month 0 and at Month 2
Frequency of VZV-specific CD4+ T-cells expressing at least 2 different immunological activation markers
Timeframe: At Month 0 and at Month 2
Anti-gE antibody concentrations
Timeframe: At Month 0 and at Month 2
Anti-VZV antibody concentrations
Timeframe: At Month 0 and at Month 2
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms.
Timeframe: During the 7-day (Days 0-6)post-vaccination period after each dose and across doses
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within the 30-day (Days 0-29) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 0 up to Month 8
Number of subjects with serious adverse events (SAEs)
Timeframe: During the period after Month 8 up to the end of the study at Month 14
Number of subjects with any new onset of autoimmune diseases (NOADs)
Timeframe: From Month 0 until Month 8
Number of subjects with any new onset of autoimmune diseases (NOADs)
Timeframe: During the period after Month 8 up to the end of the study at Month 14
Number of subjects with suspected cases of Herpes Zoster (HZ)
Timeframe: From Month 0 until Month 8
Number of subjects with suspected cases of Herpes Zoster (HZ)
Timeframe: During the period after Month 8 up to the end of the study at Month 14
Number of subjects with haematological and biochemical parameters unknown, below, within or above the normal ranges
Timeframe: At Month 0
Number of subjects with haematological and biochemical parameters unknown, below, within or above the normal ranges
Timeframe: At Month 2
Number of subjects with haematological and biochemical parameters unknown, below, within or above the normal ranges
Timeframe: At Month 3
Interventions:
Biological/vaccine: Herpes zoster vaccine GSK1437173A
Biological/vaccine: Placebo
Enrollment:
410
Observational study model:
Not applicable
Primary completion date:
2010-02-07
Time perspective:
Not applicable
Clinical publications:
Chlibek R et al. (2013) Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 208(12):1953-1961.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
January 2009 to July 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
- A male or female 50 years of age or above at the time of the first vaccination;
- Written informed consent obtained from the subject;
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from the subject;
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
A male or female 50 years of age or above at the time of the first vaccination;
Exclusion criteria:
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
- Previous vaccination against HZ;
- Previous vaccination against varicella;
- History of HZ;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
- Acute disease at the time of enrolment.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
- History of or current drug and/or alcohol abuse;
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
Trial location(s)
Location
GSK Investigational Site
Edison, New Jersey, United States, 08817
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89130
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85020
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
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
Completed
Actual primary completion date
2010-02-07
Actual study completion date
2010-02-07
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
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