A study on the long-term efficacy, safety and persistence of immune response of a vaccine against Herpes Zoster in older adults

JRCT ID: jRCT2071220038

Registered date:05/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Herpes zoster (Shingles) disease.
• Date of first enrollment: 23/08/2022
• Target sample size: 129
• Countries of recruitment: Australia,Japan,Canada,Japan,Estonia,Japan,Finland,Japan,Sweden,Japan,United States,Japan,Brazil,Japan,France,Japan,Germany,Japan,Korea,Republic of,Japan,Mexico,Japan,Spain,Japan,Taiwan,Japan,Czechia,Japan,Hong Kong,Japan,Italy,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

-Participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment.
-In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR).

Outcome(s)

• Primary Outcome: Number of participants in LTFU and Control groups with confirmed HZ cases

Secondary Outcome

-Number of participants in LTFU and Control groups with confirmed HZ cases.
-Anti-glycoprotein E (gE) antibody concentrations
-Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-gamma, IL-2, TNF-alpha, CD40L
-Percentage of participants with serious adverse events (SAEs) causally related to the study intervention

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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 of 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).

Exclude criteria

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.

Related Information

• Primary Sponsor: Ogawa Masayuki