Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Ethnic Japanese Adults

• ClinicalTrials.gov Identifier: NCT01086449
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: March 9, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in healthy ethnic Japanese adults.

Condition or disease	Intervention/treatment	Phase
Herpes Zoster	Biological: Herpes Zoster Vaccine GSK 1437173A	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Ethnic Japanese Adults
• Actual Study Start Date: March 4, 2010
• Actual Primary Completion Date: June 25, 2010
• Actual Study Completion Date: November 25, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A	Biological: Herpes Zoster Vaccine GSK 1437173A; Investigational vaccine (GSK 1437173A) administered intramuscularly.

Outcome Measures

Primary Outcome Measures :

1. Solicited local and general symptoms [ Time Frame: Day 0-6 after each vaccination ]
2. Unsolicited adverse events [ Time Frame: Day 0 -29 ]
3. Serious adverse events [ Time Frame: From dose 1 up to the end of the study ]
4. Occurrence of pre-defined adverse events [ Time Frame: From dose 1 up to study end ]
5. Haematological and biochemical parameters [ Time Frame: Months 0, 1 and 3 ]

Secondary Outcome Measures :

1. Antigen and virus-specific antibody concentrations at protocol-defined time points [ Time Frame: Months 0, 1 and 3 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
• A male or female between, and including, 18 and 30 years of age at the time of the first vaccination for inclusion in the young adults cohort or aged between, and including, 50 and 69 years of age at the time of the first vaccination for inclusion in the older adults cohort.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese).

• Female subjects of non-childbearing potential may be enrolled in the study.

  - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

• Male subjects may be enrolled in the study, if the subject:

  • has agreed to practice adequate contraception (until 2 months after completion of the vaccination series).

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Concurrent or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Immunosuppression resulting from haematopoietic stem cell transplantation, AIDS or symptomatic HIV infection.
• Previous vaccination against HZ (either a registered product or an investigational product through participation in a HZ vaccine study).
• History of HZ.
• History of any allergic disease or reaction likely to be exacerbated by any component of the vaccine.
• Receipt of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Receipt of any other immunisations within one month before the first study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunisation products [e.g., tetanus and reduced dose diphtheria toxoid (dT) vaccine, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 30 days after study vaccination.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature >= 37.5°C (99.5°F) on axillary setting;
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions (if of child bearing potential).
• Male planning to father a child or planning to discontinue contraceptive precautions.

Contacts and Locations

Locations

Australia, New South Wales

GSK Investigational Site

Randwick, New South Wales, Australia, 2031

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Study Data/Documents: Informed Consent Form 

Identifier: 113819
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 113819
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 113819
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 113819
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 113819
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 113819
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 113819
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lal H, Zahaf T, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella zoster virus subunit candidate vaccine (HZ/su): a phase-I, open-label study in Japanese adults. Hum Vaccin Immunother. 2013 Jul;9(7):1425-9. doi: 10.4161/hv.24269. Epub 2013 Apr 12.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01086449
• Other Study ID Numbers: 113819
• First Posted: March 15, 2010
• Last Update Posted: March 9, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

safety; Japanese; Herpes Zoster; immunogenicity; Herpes Zoster in healthy ethnic Japanese adults; Vaccine

Additional relevant MeSH terms:

Herpes Zoster; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Varicella Zoster Virus Infection