ClinicalTrials.gg
Not yet recruitingNCT07753265Updated Aug 7, 2026

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

An Early Phase 1 interventional study of live-attenuated zoster vaccine in Herpse Zoster, sponsored by Changchun BCHT Biotechnology Co.. Not yet recruiting. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Changchun BCHT Biotechnology Co. · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Herpse Zoster

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03

In context

Herpes Zoster

299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 247 interventional studies indexed under Herpes Zoster.

Browse Herpes Zoster studies →

Lead sponsor

Changchun BCHT Biotechnology Co. is the lead sponsor of 22 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 50 years old;
  • The participant can provide personal 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.

Exclusion criteria

Exclusion Criteria:

  • Subjects with immunodeficiency or caused by underlying diseases or treatments, including primary/acquired immunodeficiency (e.g., AIDS and other virus-induced immunodeficiency), hematologic (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 product.
  • Subjects with acute infection or acute exacerbation of chronic infection (vaccination should be deferred).
  • Women of non- 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 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 or precautions specified in the product's prescribing information.

  • Any condition that, in the Investigator's opinion, may interfere with study evaluations.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    live-attenuated zoster vaccine

    live-attenuated zoster vaccine

    Biological: live-attenuated zoster vaccine

Interventions

  • Biologicallive-attenuated zoster vaccine

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

06

What researchers measure

Primary outcomes

  1. immunogenicity

    IgG to gE/FAMA antibody/Cellular immune level

    Time frame: 30 days after administration

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07753265
Lead sponsor
Changchun BCHT Biotechnology Co.
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Aug 13, 2026 (estimated)
Primary completion
Sep 20, 2026 (estimated)
Completion
Sep 20, 2026 (estimated)
Last update
Aug 7, 2026

Study contacts

Chen Xin
Contact
chenxin@bchtpharm.com
0431-87078295
tian xiaoling
Contact
yan shaohong
principal investigator · Inner Mongolia Autonomous Region Center for Disease Control and Prevention

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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