Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01798056
First received: February 14, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.


Condition Intervention Phase
Herpes Zoster
Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥18 Years of Age With Solid Tumours Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-gE humoral immunogenicity with respect to components of the study/investigational vaccine in terms of antibody (Ab) concentrations. [ Time Frame: At Month 2. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: Within 7 days (Days 0-6) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Unsolicited adverse events (AEs). [ Time Frame: During 30 days (Days 0-29) after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs). [ Time Frame: Up to 30 days post last vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of AEs of specific interest. [ Time Frame: Up to 30 days post last vaccination. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • For immunogenicity with respect to components of the study/investigational vaccine in terms of antibody concentrations. [ Time Frame: At Month 0, Month 1, Month 6 (Visit 4, at the start of the last cycle of chemotherapy between months 4 and 13) and Month 13. ] [ Designated as safety issue: No ]
  • Occurrence of SAEs. [ Time Frame: During the period starting after 30 days post last vaccination until study end (Month 13). ] [ Designated as safety issue: No ]
  • Occurrence of AEs of specific interest. [ Time Frame: During the period starting after 30 days post last vaccination until study end (Month 13). ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: March 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HZ/su-PreChemo
Subjects will receive the first dose of HZ/su at least 10 days (up to 1 month) before start of chemotherapy cycle. The second dose of HZ/su vaccine will be administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy.
Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
Experimental: HZ/su-OnChemo
Subjects will receive the first dose of HZ/su vaccine at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of HZ/su vaccine will be administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy.
Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
Placebo Comparator: Placeb-PreChemo
Subjects will receive the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle. The second dose of placebo will be administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy.
Drug: Placebo
2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.
Placebo Comparator: Placeb-OnChemo
Subjects will receive the first dose of placebo at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo will be administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy.
Drug: Placebo
2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.

Detailed Description:

The study will be randomised into two groups based on the vaccination schedule in relation to the start of chemotherapy:

  • The OnChemo group receives their first HZ/su vaccination at start of chemotherapy.
  • The PreChemo group receives their first HZ/su vaccination at least 10 days before start of chemotherapy.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • A male or female aged 18 years or older (and has reached the age of legal consent) at the time of study entry (i.e., when informed consent is signed).
  • Subject who has been diagnosed with one or more solid tumours (defined as a solid malignancy, i.e., not a blood element malignancy).
  • Subject who is receiving or will receive a cytotoxic or immunosuppressive chemotherapy (such that the study vaccine can be administered at the latest at the start of the second cycle of chemotherapy).
  • Life expectancy of greater than one year.
  • 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.

Exclusion Criteria:

  • Subjects receiving only newer, more targeted therapies if not taken together with a classical chemotherapy.
  • Chronic administration and/or planned administration of systemic glucocorticoids within one month prior to the first vaccine dose and up to Visit 3 (Month 2). Inhaled, intra-articularly injected, and topical steroids are allowed.
  • Previous vaccination against HZ or varicella within 12 months preceding the first dose of study vaccine/ placebo.
  • Planned administration during the study of a HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
  • Previous chemotherapy course less than one month before first study vaccination.
  • Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/ placebo.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
  • Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
  • HIV infection by clinical history.
  • Acute disease and/or fever at the time of vaccination. Acute disease is defined as the presence of a moderate or severe illness with or without fever, but excludes the underlying malignancy, as well as the expected symptoms/signs associated with that disease or its treatment:

    • Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C /100.4°F on rectal setting. 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 receive the first dose of study vaccine/ placebo at the discretion of the investigator.
  • Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e., 2 months after the last dose of study vaccine/ placebo).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798056

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Canada, British Columbia
GSK Investigational Site Terminated
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Nova Scotia
GSK Investigational Site Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Canada, Ontario
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M4C 3E7
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Canada, Quebec
GSK Investigational Site Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Czech Republic
GSK Investigational Site Recruiting
Praha 8, Czech Republic, 180 00
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
France
GSK Investigational Site Recruiting
Besançon cedex, France, 25030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Ferolles-Attilly, France, 77150
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Lyon Cedex 08, France, 69373
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Montpellier, France, 34070
GSK Investigational Site Recruiting
Nimes, France, 30907
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 136-705
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 138-736
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 110-744
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Spain
GSK Investigational Site Recruiting
Badajoz, Spain, 6080
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Barcelona, Spain, 08035
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Madrid, Spain, 28034
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Madrid, Spain, 28041
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Madrid, Spain, 28040
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Madrid, Spain, 28050
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Madrid, Spain, 28007
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Majadahonda (Madrid), Spain, 28222
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Móstoles, Spain, 28935
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Pozuelo de Alarcón/Madrid, Spain, 28223
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
San Sebastian de los Reyes, Spain, 28702
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United Kingdom
GSK Investigational Site Recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Woolwich, London, United Kingdom, SE18 4QH
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Swindon, Wiltshire, United Kingdom, SN3 6BB
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Sheffield, United Kingdom, S10 2SJ
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01798056     History of Changes
Other Study ID Numbers: 116427, 2012-002966-11
Study First Received: February 14, 2013
Last Updated: September 25, 2014
Health Authority: Canada: Health Products and Food Branch of Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Korea: Korea Food and Drug Administration (KFDA)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: Statni ustav pro kontrolu leciv

Keywords provided by GlaxoSmithKline:
≥18 years of age
Chemotherapy
Solid tumours
Immunogenicity
Herpes Zoster
Safety
Shingles

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014