Prevention of Herpes ZosterPhase 4NCT06961721
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of a Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years and Older
A Phase 4 study testing Herpes Zoster Vaccine, Live in people with Prevention of Herpes Zoster, run by Changchun BCHT Biotechnology Co..
Trial summary
To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine. To evaluate the safety of the live attenuated herpes zoster vaccine. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of Herpes Zoster
- What is being tested?
- Herpes Zoster Vaccine, Live
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2025
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥40 years on enrollment day；
- The informed consent of the subject can be obtained and signed；
- The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol；
- Armpit body temperature ≤37.0℃ on the day of enrollment.
Who cannot join
- People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation/chemotherapy for a tumor；
- Do not use in persons with a history of allergic reaction to any of the components contained in this product；
- Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product；
- Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months；
- If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days；
- Treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination；
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- Received another investigational drug within 1 month prior to receiving the investigational vaccine/placebo, or is participating in another clinical trial, or plans to use it during the study；
- Taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid；
- Patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
- Previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine)；
- Any situation that the investigator considers likely to affect the evaluation of the trial。
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine.
To evaluate the safety of the live attenuated herpes zoster vaccine.
- Conditions
- Prevention of Herpes Zoster
- Being tested
- Herpes Zoster Vaccine, Live, Placebo
- Keywords
- IV Clinical Trial, Herpes Zoster Vaccine, Live, Herpes Zoster, Prevention of Herpes Zoster
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes Zoster Vaccine, LiveBiological
assigned to the vaccine group and placebo group in a 2:1 ratio.
PlaceboBiological
assigned to the vaccine group and placebo group in a 2:1 ratio.
| Study group | Role | What they receive |
|---|---|---|
| Experimental vaccine：Herpes Zoster Vaccine, Live | Experimental | After reconstitution, 0.5 ml per bottle. The dose per person is 0.5 ml. Receives: Biological: Herpes Zoster Vaccine, Live |
| Identical to the test vaccine but without the varicella-zoster virus. | Placebo comparator | After redissolving, 0.5 ml per bottle. The dose is 0.5 ml per dose for human and does not contain varicella-zoster live virus. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity:
Geometric mean titer (GMT)at Day 0 and Day 42.
Measured: Day 0 and Day 42
Immunogenicity:
geometric mean concentration (GMC) at Day 0 and Day 42.
Measured: Day 0 and Day 42
Immunogenicity:
geometric mean fold increase (GMFI)at Day 0 and Day 42
Measured: Day 0 and Day 42
Immunogenicity:
seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.
Measured: Day 0 and Day 42
Secondary outcomes (1)
Adverse Events
- Incidence, severity, and causality of solicited local，systemic adverse events within 14 days post-vaccination；
- The incidence and severity of unsolicited adverse events within 42 days after vaccination and their association with vaccination；
- Incidence of Serious Adverse events (SAE) within 42 days after vaccination。
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study startMay 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Herpes ZosterStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inner Mongolia Center for Disease Control and Prevention, Center for Disease Control and Prevention, Fujian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961721
- Sponsor's protocol ID
- PFDP20241008
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of a Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years and Older
- ClinicalTrials.gov ID
- NCT06961721
- Acronym / sponsor ID
- PFDP20241008
- Conditions
- Prevention of Herpes Zoster
- Keywords
- IV Clinical Trial, Herpes Zoster Vaccine, Live, Herpes Zoster, Prevention of Herpes Zoster
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Collaborators
- Inner Mongolia Center for Disease Control and Prevention, Center for Disease Control and Prevention, Fujian
- Study start
- May 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 May 2025 (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.
To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine.
To evaluate the safety of the live attenuated herpes zoster vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental vaccine：Herpes Zoster Vaccine, Live | Experimental | Biological: Herpes Zoster Vaccine, LiveAfter reconstitution, 0.5 ml per bottle. The dose per person is 0.5 ml. |
| Identical to the test vaccine but without the varicella-zoster virus. | Placebo comparator | Biological: PlaceboAfter redissolving, 0.5 ml per bottle. The dose is 0.5 ml per dose for human and does not contain varicella-zoster live virus. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥40 years on enrollment day；
- The informed consent of the subject can be obtained and signed；
- The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol；
- Armpit body temperature ≤37.0℃ on the day of enrollment.
Key exclusion criteria (11 listed)
- People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation/chemotherapy for a tumor；
- Do not use in persons with a history of allergic reaction to any of the components contained in this product；
- Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product；
- Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months；
- If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days；
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 |
|---|---|---|
| Herpes Zoster Vaccine, Liveassigned to the vaccine group and placebo group in a 2:1 ratio. | Biological | Experimental vaccine：Herpes Zoster Vaccine, Live |
| Placeboassigned to the vaccine group and placebo group in a 2:1 ratio. | Biological | Identical to the test vaccine but without the varicella-zoster virus. |
Primary outcome
Immunogenicity:
Time frame: Day 0 and Day 42
Geometric mean titer (GMT)at Day 0 and Day 42.
Immunogenicity:
Time frame: Day 0 and Day 42
geometric mean concentration (GMC) at Day 0 and Day 42.
Immunogenicity:
Time frame: Day 0 and Day 42
geometric mean fold increase (GMFI)at Day 0 and Day 42
Immunogenicity:
Time frame: Day 0 and Day 42
seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.
1 secondary outcome
Adverse Events
Time frame: 42 days
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 8 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Herpes Zoster Vaccine, Live in people with Prevention of Herpes 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 11 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 8 May 2025. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 shaohong yan, Undergraduate degree (13015018766, E-yshid2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity: (time frame: Day 0 and Day 42). The study lists 4 primary outcomes in all. 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 8 May 2025.