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

NCT01086449 | Completed Phase 1

• 1 other identifier: 113819
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Solicited local and general symptoms

  Day 0-6 after each vaccination

• Unsolicited adverse events

  Day 0 -29

• Serious adverse events

  From dose 1 up to the end of the study

• Occurrence of pre-defined adverse events

  From dose 1 up to study end

• Haematological and biochemical parameters

  Months 0, 1 and 3

Secondary Outcomes (1)

• Antigen and virus-specific antibody concentrations at protocol-defined time points

  Months 0, 1 and 3

Study Arms (1)

Group A

EXPERIMENTAL

Biological: Herpes Zoster Vaccine GSK 1437173A

Interventions

Herpes Zoster Vaccine GSK 1437173A BIOLOGICAL

Investigational vaccine (GSK 1437173A) administered intramuscularly.

Group A

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Related Publications (1)

• 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.

  PMID: 23584252 DERIVED

Related Links

• Results for study 113819 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 15, 2010
• Study Start: March 4, 2010
• Primary Completion: June 25, 2010
• Study Completion: November 25, 2010
• Last Updated: March 9, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)