Herpse ZosterEarly Phase 1NCT07753265
A Study on the Live-Attenuated Herpes Zoster Vaccine for Sequential Booster Immunization Following Recombinant Herpes Zoster Vaccine
A Early Phase 1 study testing live-attenuated zoster vaccine in people with Herpse Zoster, run by Changchun BCHT Biotechnology Co..
Trial summary
Evaluate the immunogenicity after boost vaccination with the live attenuated herpes zoster vaccine. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpse Zoster
- What is being tested?
- live-attenuated zoster vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2026to 20 Sep 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
tian xiaoling contact
About this study
Evaluate the immunogenicity after boost vaccination with the live attenuated herpes zoster vaccine.
- Conditions
- Herpse Zoster
- Being tested
- live-attenuated zoster vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
live-attenuated zoster vaccineBiological
one dose of live-attenuated zoster vaccine to the particpent only administered one dose of recombinant zoster vaccine
| Study group | Role | What they receive |
|---|---|---|
| live-attenuated zoster vaccine | Experimental | live-attenuated zoster vaccine Receives: Biological: live-attenuated zoster vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity
IgG to gE/FAMA antibody/Cellular immune level
Measured: 30 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start13 Aug 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpse ZosterStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yan shaohong, Principal investigator, Inner Mongolia Autonomous Region Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753265
- Sponsor's protocol ID
- PFDP20260520
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Live-Attenuated Herpes Zoster Vaccine for Sequential Booster Immunization Following Recombinant Herpes Zoster Vaccine
- ClinicalTrials.gov ID
- NCT07753265
- Acronym / sponsor ID
- PFDP20260520
- Conditions
- Herpse Zoster
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the immunogenicity after boost vaccination with the live attenuated herpes zoster vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| live-attenuated zoster vaccine | Experimental | Biological: live-attenuated zoster vaccinelive-attenuated zoster vaccine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| live-attenuated zoster vaccineone dose of live-attenuated zoster vaccine to the particpent only administered one dose of recombinant zoster vaccine | Biological | live-attenuated zoster vaccine |
Primary outcome
immunogenicity
Time frame: 30 days after administration
IgG to gE/FAMA antibody/Cellular immune level
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
tian xiaoling contact
yan shaohong principal investigator
Inner Mongolia Autonomous Region Center for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing live-attenuated zoster vaccine in people with Herpse Zoster, run by Changchun BCHT Biotechnology Co..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Xin (0431-87078295, chenxin@bchtpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunogenicity (time frame: 30 days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.