A Phase 3b, Open-label, Multi-country, Multi-centre, Long-term Follow-up Study of ZOSTER-049 (Follow-up of ZOSTER-006/022 Studies) to Assess the Prophylactic Efficacy, Safety and Persistence of Immune Response of a Herpes Zoster Subunit Vaccine and Assessment of Persistence of Immune Response and Safety of 1 or 2 Additional Doses Administered in ZOSTER-049 in 2 Subgroups of Older Adults
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,038
- 试验地点
- 107
- 主要终点
- Number of participants in LTFU and Control groups with confirmed HZ cases
研究概览
简要总结
The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol.
- •Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
- •Medically stable participants as established by medical history and clinical examination before entering into the study.
- •Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies).
排除标准
- •Medical conditions
- •Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period.
- •Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049).
- •Prior/Concurrent clinical study experience
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.
研究组 & 干预措施
LTFU Group
Participants who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and are followed for long-term vaccine efficacy and safety in the current ZOSTER-101 study.
干预措施: HZ/su vaccine (Biological)
1-Additional Dose Group
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and one additional dose of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
干预措施: HZ/su vaccine (Biological)
Revaccination Group
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and two additional doses of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
干预措施: HZ/su vaccine (Biological)
Control Group
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the ZOSTER-049 study, but who served as a control for the two groups that received 1 or 2 additional doses of HZ/su (1-Additional Dose and Revaccination groups). In the current ZOSTER-101 study, this Control group is used in the evaluation of the long-term vaccine efficacy, safety and as a control for persistence of immunogenicity to additional doses administered in ZOSTER-049 study.
干预措施: HZ/su vaccine (Biological)
结局指标
主要结局
Number of participants in LTFU and Control groups with confirmed HZ cases
时间窗: During the total duration of ZOSTER-101 study (Day 1 through Month 48)
A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed in two ways: * By PCR; * By the HZ Ascertainment Committee (HZAC).
次要结局
- Number of participants in LTFU and Control groups with confirmed HZ cases(From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48)
- Anti-glycoprotein E (gE) antibody concentrations(At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study)
- Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention(During the total duration of the ZOSTER-101 study (Day 1 through Month 48))
- Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L(At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study)
- Percentage of participants with serious adverse events (SAEs) causally related to the study intervention(During the total duration of the ZOSTER-101 study (Day 1 through Month 48))
- Percentage of participants with HZ-related complications of confirmed HZ(During the total duration of the ZOSTER-101 study (Day 1 through Month 48))