Clinical Trials List
Protocol NumberZOSTER-039 (116428)
2013-04-16 - 2015-06-30
Phase III
Terminated3
Study ended1
A Phase III, randomised, observer-blind, placebocontrolled, multicentre study to assess the safety and immunogenicity of GSK Biologicals’ Herpes Zoster HZ/su candidate vaccine when administered intramuscularly on a two-dose schedule to adults aged 18 years and older with haematologic malignancies.
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Trial Applicant
GlaxoSmithKline
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Sponsor
GSK
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 余垣斌 Division of Hematology & Oncology
- Chun-Yu Liu Division of Hematology & Oncology
- Liang-Tsai Hsiao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tung-Liang Lin Division of Hematology & Oncology
- Ming-Chung Kao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林柏翰 Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
3 Study ended
Condition/Disease
Prevention of Herpes Zoster (HZ) and related complications in adults ≥50 years of age and immunocompromised adults ≥18 years of age. The current study will be performed in immunocompromised adults ≥18 years of age.
Objectives
To control the risk of an erroneous conclusion, a hierarchical procedure will be used for the multiple confirmatory study
objectives with the possibility to conclude independently between the four confirmatory objectives.
Test Drug
gE/AS01B Vaccine
Active Ingredient
VZV gE antigen + AS01B adjuvant
Dosage Form
Dosage
0.5ml
Endpoints
Primary
Occurrence of solicited local and general symptoms.
Occurrence, intensity and duration of each solicited
local symptom within 7 days (Days 0-6) after each
vaccination, in all subjects.
Occurrence, intensity, duration and relationship to
vaccination of each solicited general symptom within 7
days (Days 0-6) after each vaccination, in all subjects.
Occurrence of unsolicited adverse events (AEs)
Occurrence, intensity and relationship to vaccination of
unsolicited AEs during 30 days (Days 0-29) after each
vaccination, according to the Medical Dictionary for
Regulatory Activities (MedDRA) classification, in all
subjects.
Occurrence of serious adverse events (SAEs).
Occurrence and relationship to vaccination of all SAEs
up to 30 days post last vaccination in all subjects.
Occurrence of AEs of specific interest.
Occurrence and relationship to vaccination of any
potential Immune-Mediated Diseases (pIMDs) up to 30
days post last vaccination in all subjects.
Anti gE humoral immunogenicity in all vaccinated
subjects excluding subjects with Non-Hodgkin B-cell
Lymphoma and Chronic Lymphocytic Leukaemia.
Vaccine response for anti-gE humoral immunogenicity,
as determined by enzyme-linked immunosorbent assay
(ELISA), at Month 2.
Secondary
Occurrence of serious adverse events (SAEs).
Occurrence and relationship to vaccination of all SAEs
from the first vaccination up to 6 months post last
vaccination in at least 50% of the total vaccinated
cohort.
Occurrence and relationship to vaccination of all SAEs
from 30 days post last vaccination until study end in all
subjects.
Occurrence of AEs of specific interest.
Occurrence of any pIMDs from first vaccination up to 6
months post last vaccination in at least 50% of the total
vaccinated cohort.
Occurrence of any pIMDs from 30 days post last
vaccination until study end in all subjects.
Anti gE humoral immunogenicity in all vaccinated subjects
excluding subjects with Non-Hodgkin B-cell Lymphoma.
Vaccine response for anti-gE humoral immunogenicity,
as determined by ELISA, at Month 2.
Anti gE humoral immunogenicity in all vaccinated subjects
excluding subjects with Non-Hodgkin B-cell Lymphoma
and Chronic Lymphocytic Leukaemia.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 2.
Anti gE humoral immunogenicity in all vaccinated subjects
excluding subjects with Non-Hodgkin B-cell Lymphoma.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 2.
Occurrence of confirmed HZ cases.
Occurrence of confirmed HZ cases from Month 0 until
study end.
Anti-gE-humoral immunogenicity in all vaccinated
subjects.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 0, Month 1, Month 2 and Month 13.
Vaccine response for anti-gE humoral immunogenicity,
as determined by ELISA, at Month 1, Month 2 and
Month 13.
gE-specific CD4+ T-cell-mediated immunogenicity
response in the CMI sub-cohort.
Frequencies of gE-specific CD4+ T-cells, expressing at
least 2 activation markers (from among IFN-γ, IL-2,
TNF-α and CD40L), as determined by in vitro
intracellular cytokine staining (ICS), at Month 0, Month
1, Month 2 and Month 13.
Vaccine response for gE-specific CD4+ T-cells
expressing at least 2 activation markers (from among
IFN-γ, IL-2, TNF-α and CD40L), as determined by in
vitro ICS, at Month 1, Month 2 and Month 13.
Anti-gE humoral immunogenicity at Month 0 and at Month
2 in subjects with confirmed HZ and matched controls.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 0 and at Month 2.
Occurrence of solicited local and general symptoms.
Occurrence, intensity and duration of each solicited
local symptom within 7 days (Days 0-6) after each
vaccination, in all subjects.
Occurrence, intensity, duration and relationship to
vaccination of each solicited general symptom within 7
days (Days 0-6) after each vaccination, in all subjects.
Occurrence of unsolicited adverse events (AEs)
Occurrence, intensity and relationship to vaccination of
unsolicited AEs during 30 days (Days 0-29) after each
vaccination, according to the Medical Dictionary for
Regulatory Activities (MedDRA) classification, in all
subjects.
Occurrence of serious adverse events (SAEs).
Occurrence and relationship to vaccination of all SAEs
up to 30 days post last vaccination in all subjects.
Occurrence of AEs of specific interest.
Occurrence and relationship to vaccination of any
potential Immune-Mediated Diseases (pIMDs) up to 30
days post last vaccination in all subjects.
Anti gE humoral immunogenicity in all vaccinated
subjects excluding subjects with Non-Hodgkin B-cell
Lymphoma and Chronic Lymphocytic Leukaemia.
Vaccine response for anti-gE humoral immunogenicity,
as determined by enzyme-linked immunosorbent assay
(ELISA), at Month 2.
Secondary
Occurrence of serious adverse events (SAEs).
Occurrence and relationship to vaccination of all SAEs
from the first vaccination up to 6 months post last
vaccination in at least 50% of the total vaccinated
cohort.
Occurrence and relationship to vaccination of all SAEs
from 30 days post last vaccination until study end in all
subjects.
Occurrence of AEs of specific interest.
Occurrence of any pIMDs from first vaccination up to 6
months post last vaccination in at least 50% of the total
vaccinated cohort.
Occurrence of any pIMDs from 30 days post last
vaccination until study end in all subjects.
Anti gE humoral immunogenicity in all vaccinated subjects
excluding subjects with Non-Hodgkin B-cell Lymphoma.
Vaccine response for anti-gE humoral immunogenicity,
as determined by ELISA, at Month 2.
Anti gE humoral immunogenicity in all vaccinated subjects
excluding subjects with Non-Hodgkin B-cell Lymphoma
and Chronic Lymphocytic Leukaemia.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 2.
Anti gE humoral immunogenicity in all vaccinated subjects
excluding subjects with Non-Hodgkin B-cell Lymphoma.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 2.
Occurrence of confirmed HZ cases.
Occurrence of confirmed HZ cases from Month 0 until
study end.
Anti-gE-humoral immunogenicity in all vaccinated
subjects.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 0, Month 1, Month 2 and Month 13.
Vaccine response for anti-gE humoral immunogenicity,
as determined by ELISA, at Month 1, Month 2 and
Month 13.
gE-specific CD4+ T-cell-mediated immunogenicity
response in the CMI sub-cohort.
Frequencies of gE-specific CD4+ T-cells, expressing at
least 2 activation markers (from among IFN-γ, IL-2,
TNF-α and CD40L), as determined by in vitro
intracellular cytokine staining (ICS), at Month 0, Month
1, Month 2 and Month 13.
Vaccine response for gE-specific CD4+ T-cells
expressing at least 2 activation markers (from among
IFN-γ, IL-2, TNF-α and CD40L), as determined by in
vitro ICS, at Month 1, Month 2 and Month 13.
Anti-gE humoral immunogenicity at Month 0 and at Month
2 in subjects with confirmed HZ and matched controls.
Anti-gE antibody concentrations, as determined by
ELISA, at Month 0 and at Month 2.
Inclution Criteria
All subjects must satisfy ALL the following criteria at study entry:
Subjects who the investigator believes can and will comply with the requirements of
the protocol (e.g. completion of the diary cards, return for follow-up visits, ability to
have scheduled contacts to allow evaluation during the study);
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) . Refer to Section
12 for country-specific age of legal consent;
Subject who has been diagnosed with one or more haematologic malignancies prior
to the first vaccination and who is receiving, is scheduled to receive or has just
finished immunosuppressive cancer therapy to treat this condition.
Cancer therapy may be chemotherapy and/or immunotherapy. If radiotherapy, it
must be in combination with either chemotherapy or immunotherapy.
No restrictions on date of diagnosis with respect to date of first study vaccination
or on any cancer therapies subjects may have had prior to the first study
vaccination.
See Section 6.6.4.7 for required timing of vaccination in relation to cancer
therapy cycles.
Life expectancy greater than or equal to 12 months, as assessed by the investigator.
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;
Please refer to the glossary of terms for the definition of menarche and 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.
Please refer to the glossary of terms for the definition of adequate contraception.
Subjects who the investigator believes can and will comply with the requirements of
the protocol (e.g. completion of the diary cards, return for follow-up visits, ability to
have scheduled contacts to allow evaluation during the study);
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) . Refer to Section
12 for country-specific age of legal consent;
Subject who has been diagnosed with one or more haematologic malignancies prior
to the first vaccination and who is receiving, is scheduled to receive or has just
finished immunosuppressive cancer therapy to treat this condition.
Cancer therapy may be chemotherapy and/or immunotherapy. If radiotherapy, it
must be in combination with either chemotherapy or immunotherapy.
No restrictions on date of diagnosis with respect to date of first study vaccination
or on any cancer therapies subjects may have had prior to the first study
vaccination.
See Section 6.6.4.7 for required timing of vaccination in relation to cancer
therapy cycles.
Life expectancy greater than or equal to 12 months, as assessed by the investigator.
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;
Please refer to the glossary of terms for the definition of menarche and 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.
Please refer to the glossary of terms for the definition of adequate contraception.
Exclusion Criteria
The following criteria should be checked at the time of study entry. If ANY exclusion
criterion applies, the subject must not be included in the study:
Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only
oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intravenous cancer therapy in combination with oral therapy may be enrolled).
Subject receiving radiotherapy alone as treatment for his/her haematologic
malignancy.
Planned haematopoietic stem cell transplant (HCT) during the study period. (If a
HCT occurred prior to enrolment in the study, the subject may not receive study
vaccine until at least 50 days after the transplant procedure.)
HIV infection by clinical history.
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/placebo, or
planned use during the study period. However, the investigational use of a registered
product to treat the subject’s underlying disease, is allowed;
Previous vaccination against HZ or varicella within the 12 months preceding the first
dose of study vaccine/placebo;
Planned administration during the study of a HZ or varicella vaccine (including an
investigational or non-registered vaccine) other than the study vaccine;
Occurrence of a varicella or HZ episode by clinical history within the 12 months
preceding the first dose of study vaccine/placebo;
History of any reaction or hypersensitivity likely to be exacerbated by any
component of the vaccine;
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.
Administration or planned administration of a non-replicating vaccine* within 8 days
prior to or within 14 days after either dose of study vaccine.
* inactivated and subunit vaccines, including inactivated and subunit influenza
vaccines and pneumococcal conjugate vaccines.
Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue contraceptive
precautions before Month 3 (i.e., 2 months after the last dose of study
criterion applies, the subject must not be included in the study:
Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only
oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intravenous cancer therapy in combination with oral therapy may be enrolled).
Subject receiving radiotherapy alone as treatment for his/her haematologic
malignancy.
Planned haematopoietic stem cell transplant (HCT) during the study period. (If a
HCT occurred prior to enrolment in the study, the subject may not receive study
vaccine until at least 50 days after the transplant procedure.)
HIV infection by clinical history.
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/placebo, or
planned use during the study period. However, the investigational use of a registered
product to treat the subject’s underlying disease, is allowed;
Previous vaccination against HZ or varicella within the 12 months preceding the first
dose of study vaccine/placebo;
Planned administration during the study of a HZ or varicella vaccine (including an
investigational or non-registered vaccine) other than the study vaccine;
Occurrence of a varicella or HZ episode by clinical history within the 12 months
preceding the first dose of study vaccine/placebo;
History of any reaction or hypersensitivity likely to be exacerbated by any
component of the vaccine;
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.
Administration or planned administration of a non-replicating vaccine* within 8 days
prior to or within 14 days after either dose of study vaccine.
* inactivated and subunit vaccines, including inactivated and subunit influenza
vaccines and pneumococcal conjugate vaccines.
Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue contraceptive
precautions before Month 3 (i.e., 2 months after the last dose of study
The Estimated Number of Participants
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Taiwan
20 participants
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Global
502 participants
