Last updated: 11/07/2018 02:55:14
Safety & immunogenicity of GlaxoSmithKline Biologicals’ herpes zoster vaccine 1437173A
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety and immunogenicity of GlaxoSmithKline Biologicals’ herpes zoster vaccine 1437173A
Trial description: The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Number of subjects with any and grade 3 unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0-29) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: Any time during the study up to Day 29 after the last vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Day 0 up to Month 15)
Number of subjects with any new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders
Timeframe: Within the 30-day (Days 0-29) post last vaccination period
Number of subjects with any new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders
Timeframe: During the entire study period (from Day 0 to Month 15)
Number of subjects with hematological and biochemical parameters with respect to normal laboratory ranges
Timeframe: At Month 0
Number of subjects with hematological and biochemical parameters with respect to normal laboratory ranges
Timeframe: At Month 1
Number of subjects with hematological and biochemical parameters with respect to normal laboratory ranges
Timeframe: At Month 2
Number of subjects with hematological and biochemical parameters with respect to normal laboratory ranges
Timeframe: At Month 3
Number of subjects with hematological and biochemical parameters with respect to normal laboratory ranges
Timeframe: At Month 4
Frequency of gE-specific cluster of differentiation 4 (CD4) T-cells expressing at least 2 cytokines
Timeframe: At Month 4
Anti-glycoprotein E (anti-gE) geometric mean antibody concentrations
Timeframe: At Month 4
Anti-gE mean antibody concentrations
Timeframe: At Month 4
Secondary outcomes:
Frequency of CD4 T-cells specific for Varicella Zoster Virus (VZV) antigens
Timeframe: At Months 0, 1, 2, 3, 4 and 15
Frequency of gE-specific cluster of differentiation 4 (CD4) T-cells expressing at least 2 cytokines
Timeframe: At Months 0, 1, 2, 3 and 15
Varicella Zoster Virus (VZV)-specific geometric mean antibody concentrations
Timeframe: At Months 0, 1, 2, 3, 4 and 15
VZV-specific mean antibody concentrations
Timeframe: At Months 0, 1, 2, 3, 4 and 15
Anti-gE geometric mean antibody concentrations
Timeframe: At Months 0, 1, 2, 3 and 15
Anti-gE mean antibody concentrations
Timeframe: At Months 0, 1, 2, 3 and 15
Number of subjects with confirmed Herpes Zoster (HZ) cases
Timeframe: During the entire study period (from Day 0 to Month 15)
Interventions:
Biological/vaccine: Herpes Zoster Vaccine 1437173A
Biological/vaccine: Placebo vaccine (saline)
Enrollment:
121
Observational study model:
Not applicable
Primary completion date:
2011-26-04
Time perspective:
Not applicable
Clinical publications:
Stadtmauer EA et al. (2014) A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 124(19):2921-2929.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
July 2009 to March 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
- Male and female subjects at least 18 years old at the time of vaccination;
- Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
Inclusion and exclusion criteria
Inclusion criteria:
- Male and female subjects at least 18 years old at the time of vaccination;
- Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;
- Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs
- Written informed consent obtained from the subject;
- 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.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
Exclusion criteria:
- Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
- Administration of immunoglobulins since transplantation;
- Previous vaccination against varicella or HZ;
- History of HZ within the previous 12 months;
- Known exposure to VZV since transplantation;
- Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Hypersensitivity or intolerance to acyclovir or valacyclovir;
- Pregnant or lactating female.
Use of any investigational non-registered product 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
Little Rock, Arkansas, United States, 72205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Study Complete
Location
GSK Investigational Site
Duarte, California, United States, 91010
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94143
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Location
GSK Investigational Site
Minnesota, Minnesota, United States, 55455
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10065
Status
Study Complete
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
Completed
Actual primary completion date
2011-26-04
Actual study completion date
2012-21-03
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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