Clinical Trials List
Protocol Number115523 (ZOSTER-002)
Completed
2012-12-01 - 2017-10-01
Phase III
Terminated5
ICD-10B02.1
Zoster meningitis
ICD-9053.0
Herpes zoster with meningitis
A phase III, randomised, observer-blind, placebo- controlled, multicentre, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of GSK Biologicals’ herpes zoster gE/AS01B candidate vaccine when administered intramuscularly on a two- dose schedule to adult autologous haematopoietic stem cell transplant (HCT) recipients.
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Trial Applicant
GlaxoSmithKline
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Sponsor
GlaxoSmithKline
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chieh-Lin Teng Division of Hematology & Oncology
- 楊陽生 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tung-Liang Lin Division of Hematology & Oncology
- 張 鴻 Division of Hematology & Oncology
- Ming-Chung Kao Division of Hematology & Oncology
- 洪玉馨 Division of Hematology & Oncology
- 湯崇志 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Li-Yuan Bai Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Che-Hung Lin 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
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
herpes zoster
Objectives
Vaccination against herpes zoster (HZ) in adult autologous HCT recipients
Test Drug
gE/AS01B vaccine
Active Ingredient
gE/AS01B vaccine
Dosage Form
Monodose Vial
Dosage
1 dose/ carton
Endpoints
Primary Endpoint:
To evaluate VE in the prevention of HZ in autologous HCT recipients 18 years of age and older.
To evaluate VE in the prevention of HZ in autologous HCT recipients 18 years of age and older.
Inclution Criteria
All subjects must satisfy ALL the following criteria at study entry:
Study entry (enrolment) occurs at the Pre-vaccination visit.
● 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, have regular contact to allow evaluation during the study);
● Written informed consent obtained from the subject;
● A male or female aged 18 years or older at the time of study entry. Refer to Section
12.1 for country-specific age of legal consent; (Amended 16 May 2012)
● Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs (tandem autologous HCT recipients may participate following their final HCT);
● Female subjects of non-childbearing potential may be enrolled in the study; For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Please refer to the GLOSSARY OF TERMS for the definition of menopause.
OR
Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, 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 12 months after completion of the vaccination series (i.e., until Month 13).
Please refer to the GLOSSARY OF TERMS for the definition of adequate contraception.
Study entry (enrolment) occurs at the Pre-vaccination visit.
● 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, have regular contact to allow evaluation during the study);
● Written informed consent obtained from the subject;
● A male or female aged 18 years or older at the time of study entry. Refer to Section
12.1 for country-specific age of legal consent; (Amended 16 May 2012)
● Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs (tandem autologous HCT recipients may participate following their final HCT);
● Female subjects of non-childbearing potential may be enrolled in the study; For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Please refer to the GLOSSARY OF TERMS for the definition of menopause.
OR
Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, 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 12 months after completion of the vaccination series (i.e., until Month 13).
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:
● 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 or non-registered product to treat the subject’s underlying disease for which the HCT was undertaken, or a complication of the 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 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment;
● Prophylactic antiviral therapy (1) with activity against VZV expected to last more than 6 months after transplantation; (Amended 16 May 2012)
(1) Prophylactic antiviral therapy with activity against VZV (e.g. Acyclovir, Valacyclovir, Famciclovir, Penciclovir, Brivudin, Ganciclovir, Valganciclovir) following HCT to be administered according to local standard of care based on the Investigator’s judgment (duration, choice of antiviral agent and dose of antiviral agent). Subjects for whom prophylactic antiviral therapy is expected to be given for 6 months or less following HCT may be enrolled. (Amended 16 May 2012)
● Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines (e.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines) may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo;
● HIV infection by clinical history;
● Pregnant or lactating female;
● Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
● 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 or non-registered product to treat the subject’s underlying disease for which the HCT was undertaken, or a complication of the 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 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment;
● Prophylactic antiviral therapy (1) with activity against VZV expected to last more than 6 months after transplantation; (Amended 16 May 2012)
(1) Prophylactic antiviral therapy with activity against VZV (e.g. Acyclovir, Valacyclovir, Famciclovir, Penciclovir, Brivudin, Ganciclovir, Valganciclovir) following HCT to be administered according to local standard of care based on the Investigator’s judgment (duration, choice of antiviral agent and dose of antiviral agent). Subjects for whom prophylactic antiviral therapy is expected to be given for 6 months or less following HCT may be enrolled. (Amended 16 May 2012)
● Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines (e.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines) may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo;
● HIV infection by clinical history;
● Pregnant or lactating female;
● Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
The Estimated Number of Participants
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Taiwan
20 participants
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Global
1747 participants
