A Study on the Live-Attenuated Herpes Zoster Vaccine for Sequential Booster Immunization Following Recombinant Herpes Zoster Vaccine

NCT07753265 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PFDP20260520
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the immunogenicity after boost vaccination with the live attenuated herpes zoster vaccine.

Conditions

Herpse Zoster

Outcome Measures

Primary Outcomes (1)

• immunogenicity

  IgG to gE/FAMA antibody/Cellular immune level

  30 days after administration

Study Arms (1)

live-attenuated zoster vaccine

EXPERIMENTAL

live-attenuated zoster vaccine

Biological: live-attenuated zoster vaccine

Interventions

live-attenuated zoster vaccine BIOLOGICAL

one dose of live-attenuated zoster vaccine to the particpent only administered one dose of recombinant zoster vaccine

live-attenuated zoster vaccine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years old;
• The participant can provide personal informed consent and sign the informed consent form;
• temperature ≤ 37.0℃ on the day of administration;
• capable of complying with the requirements of the clinical trial protocol to complete the trial.

You may not qualify if:

• Subjects with immunodeficiency or immunosuppression caused by underlying diseases or treatments, including primary/acquired immunodeficiency (e.g., AIDS and other virus-induced immunodeficiency), hematologic malignancies (leukemia, lymphoma or other bone marrow/lymphoid neoplasms), ongoing immunosuppressive therapy, or radiotherapy/chemotherapy for malignancies.
• Subjects with a history of allergic reaction to any component of the investigational product.
• Subjects with acute infection or acute exacerbation of chronic infection (vaccination should be deferred).
• Women of non-postmenopausal status with positive pregnancy test, pregnant or lactating women, or those planning pregnancy within 6 months.
• Subjects with prior history of herpes zoster.
• Subjects with prior receipt of varicella or herpes zoster vaccine.
• Receipt of live-attenuated vaccines within 14 days, or subunit/inactivated vaccines within 7 days prior to study vaccination.
• Receipt of whole-blood, plasma or immunoglobulin within 5 months before, or within 3 weeks after study vaccination.
• Receipt of investigational drugs from other clinical trials within 1 month before study vaccination, current participation in another clinical trial, or planned use of investigational agents during study period.
• Current or planned use of salicylates (including aspirin, diflunisal, etc.).
• Uncontrolled abnormal blood pressure at screening (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite medication).
• Subjects meeting contraindications or precautions specified in the product's prescribing information.
• Any condition that, in the Investigator's opinion, may interfere with study evaluations.

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead

Study Officials

• yan shaohong

  Inner Mongolia Autonomous Region Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Xin

CONTACT

0431-87078295; chenxin@bchtpharm.com

tian xiaoling

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): August 13, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share