Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years

Study Description

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Brief Summary:

The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.

Condition or disease	Intervention/treatment	Phase
Herpes Zoster	Biological: Herpes zoster vaccine GSK1437173A	Phase 3

Detailed Description:

There are 2 treatment groups in this study based upon the mode of vaccine administration.

The humoral immunogenicity (HI) will be measured in all subjects.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Versus Intramuscularly in Adults Aged 50 Years or Older
Study Start Date :	June 17, 2013
Actual Primary Completion Date :	October 10, 2013
Actual Study Completion Date :	November 11, 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: SC HZ/su Group; Subjects will receive HZ/su vaccine administered SC on a 0,2-month schedule.	Biological: Herpes zoster vaccine GSK1437173A; HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.
Active Comparator: IM HZ/su Group; Subjects will receive HZ/su vaccine administered IM on a 0,2-month schedule.	Biological: Herpes zoster vaccine GSK1437173A; HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.

Outcome Measures

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Primary Outcome Measures :

1. Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations ≥ 18 mIU/mL [ Time Frame: Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3) ]
2. Anti-gE Antibody Concentrations [ Time Frame: Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3) ]
3. Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations [ Time Frame: At two months after Dose 1 (M2) and three months after Dose 2 (M3) ]
   Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
4. Anti-gE Antibody Concentrations [ Time Frame: Before vaccination (PRE), at two months after dose 1 (M2) and three months after Dose 2 (M3) ]
5. Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses ]
   The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.
6. Number of Subjects With Solicited General Symptoms [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses ]
   Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature >39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.
7. Number of Days With Local Symptoms [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) ]
8. Number of Days With General Symptoms [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) ]
9. Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) [ Time Frame: Up to 30 days post vaccination period ]
10. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within 30 days (Days 0-29) post vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
11. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days post vaccination period ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Secondary Outcome Measures :

1. Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL [ Time Frame: At Month 14 ]
2. Anti-gE Antibody Concentrations [ Time Frame: At Month 14 ]
3. Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations [ Time Frame: Twelve Months after Dose 2 (M14) ]
   Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
4. Number of Subjects With pIMDs [ Time Frame: Up to Month 14 post vaccination period ]
5. Number of Subjects With SAEs [ Time Frame: Up to Month 14 post vaccination period ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Subject, residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese.
• Subject has provided written informed consent.
• Subject, male or female, who is 50 YOA or older at the time of the first vaccination.
• Subject, if female, of non-childbearing potential may be enrolled in the study.

• Subject, if female, 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 (i.e., for 2 months after Month 2).
• 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, or planned use during the study period.
• Concurrently participating 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.
• Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
• Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
• Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
• Administration of immunoglobulins and/or any blood products within the three (3) months preceding the first dose of study vaccine or planned administration during the study period.

• Chronic administration (defined as >14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

  • For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed.
  • Inhaled, topical, and intra-articular corticosteroids are allowed.
• Administration or planned administration of long-acting immune-modifying drugs (e.g., infliximab) within six months prior to the first vaccine dose through the duration of the study period.
• History of HZ.
• Previous vaccination against HZ or varicella (registered or investigational product).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
• Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.

• Acute disease and/or fever at the time of vaccination:

  • Fever is defined as temperature ≥37.5°C (99.5°F) for oral, axillary, or tympanic route, or ≥38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be oral.
  • 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 childbearing potential) through Month 4 (i.e., 2 months after the second dose of study vaccine).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
GSK Investigational Site
Fukuoka, Japan, 812-0025

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Statistical Analysis Plan 

Identifier: 116760
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 116760
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 116760
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 116760
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 116760
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 116760
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 116760
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):

Vink P, Shiramoto M, Ogawa M, Eda M, Douha M, Heineman T, Lal H. Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged ≥50 years when administered subcutaneously vs. intramuscularly. Hum Vaccin Immunother. 2017 Mar 4;13(3):574-578. doi: 10.1080/21645515.2016.1232787. Epub 2016 Dec 9.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01777321 History of Changes
Other Study ID Numbers:	116760; 2012-005671-14 ( EudraCT Number )
First Posted:	January 28, 2013
Results First Posted:	January 6, 2017
Last Update Posted:	December 21, 2017
Last Verified:	November 2017
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.
URL:	http://

Keywords provided by GlaxoSmithKline:

Herpes Zoster; Intramuscular; Subcutaneous; Safety	≥50 years of age; Adults; Immunogenicity; Elderly

Additional relevant MeSH terms:

Herpes Zoster; Herpesviridae Infections; DNA Virus Infections; Virus Diseases	Vaccines; Immunologic Factors; Physiological Effects of Drugs