HerpesPhase 1NCT07633197
A Phase I Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell)
A Phase 1 study testing Recombinant Herpes Zoster Vaccine in people with Herpes, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of different dosages of recombinant zoster vaccine (CHO cell) when administered to adults aged 40 years and older. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes
- What is being tested?
- Recombinant Herpes Zoster Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2026to 30 Nov 2027
- Phase
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are aged ≥40 years on the day of enrollment and can provide legal identity documents;
- The participant voluntarily agrees to take part in the trial and is capable of fully understanding and signing the informed consent form;
- The participant is able to comply with the requirements specified in the clinical trial protocol.
Who cannot join
- Axillary body temperature >37.3°C on the day of enrollment*;
- Subjects with a prior history of herpes zoster, or having had close contact with patients with chickenpox/herpes zoster within 30 days prior to enrollment;
- Subjects with previous vaccination history of chickenpox or herpes zoster vaccine;
- Subjects allergic to any component of the investigational vaccine (Varicella-Zoster Virus glycoprotein E, BK-02 adjuvant, dipotassium hydrogen phosphate trihydrate, sodium dihydrogen phosphate monohydrate, sucrose, Polysorbate 80), or with a history of severe hypersensitivity to any drugs or vaccines;
- Confirmed or suspected immunosuppression or immunodeficiency disorders induced by underlying diseases or immunosuppressive/cytotoxic therapies, including but not limited to subjects diagnosed with immunodeficiency diseases, malignant tumors, HIV infection, leukemia, lymphoma, Hodgkin's disease, or compromised immunity resulting from organ and bone marrow transplantation;
- Subjects with asplenia or functional asplenia, or autoimmune diseases such as Hashimoto's thyroiditis, vitiligo, rheumatoid arthritis, ankylosing spondylitis;
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- Subjects suffering from severe illnesses or potential severe underlying diseases that may interfere with or prevent trial completion (e.g., pulmonary heart disease, pulmonary edema, uncontrolled hypertension despite medication: for participants aged 40-59 years, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; for participants aged ≥60 years, systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg, severe hepatic and renal diseases, complicated diabetes mellitus, severe cardiovascular diseases, etc.);
- Subjects presenting with acute illnesses (e.g., acute upper respiratory tract infection accompanied by fever, dyspnea and other symptoms) within 3 days before vaccination, or in acute exacerbation phase of chronic diseases, or receiving antipyretic, analgesic or anti-allergy medications*;
- Subjects who received immunosuppressive therapy within 6 months prior to vaccination or plan to receive such therapy from enrollment through 1 month after completion of full-course immunization (e.g., systemic glucocorticoids administered for ≥14 consecutive days at a daily dose of ≥2 mg/kg or ≥20 mg prednisone or equivalent prednisone dosage; topical steroids including inhalants, nasal sprays, intra-articular injections, eye drops and ointments are excluded); subjects administered long-acting immunomodulatory agents (e.g., infliximab) within 6 months before the first vaccination or scheduled to receive such agents from enrollment to 1 month after full vaccination completion;
- Subjects receiving whole blood, plasma or immunoglobulin transfusion within 3 months prior to vaccination or planning to receive such treatments from enrollment through 1 month after completion of full-course immunization;
- Females of childbearing age planning pregnancy during the trial, or who are pregnant (positive pregnancy test result) or breastfeeding; Subjects with a medical history of thrombocytopenia or other coagulation disorders contraindicating intramuscular injection;
- Subjects with clinically significant abnormal findings in laboratory tests or electrocardiogram confirmed by a clinician before the first vaccine dose;
- Subjects with personal or family history of convulsion, epilepsy, encephalopathy (e.g., cerebral nerve tissue damage caused by congenital cerebral dysplasia, craniocerebral trauma, brain tumor, cerebral hemorrhage, cerebral infarction except lacunar infarction and cerebral infarction without sequelae, intracranial infection, chemical drug poisoning, etc.), psychiatric disorders or other severe neurological diseases;
- Subjects who received live attenuated vaccines within 14 days before vaccination, or recombinant protein vaccines/inactivated vaccines within 7 days before vaccination*;
- Subjects who have used any investigational or unapproved products (drugs, biological products or medical devices) within 3 months prior to vaccination or intend to use such products during the trial period;
- Any other conditions deemed likely to interfere with trial evaluation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Clinical Trial for Randomized, Blinded, Placebo-Controlled Evaluation of Safety, Tolerability and Preliminary Exploratory Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cell) With Different Doses in Adults Aged 40 Years and Above
To evaluate the safety and tolerability of different dosages of recombinant zoster vaccine (CHO cell) when administered to adults aged 40 years and older.
Read the detailed description
30 days After each dose of vaccination
- Conditions
- Herpes
- Being tested
- Recombinant Herpes Zoster Vaccine, adjuvant placebo, Placebo
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Herpes Zoster VaccineBiological
This product is for intramuscular injection only, with the deltoid muscle of the upper arm as the preferred vaccination site. The immunization schedule consists of two doses at 0.5 ml per dose, and the second dose shall be administered two months apart from the first dose.
adjuvant placeboBiological
This product is for intramuscular injection only, with the deltoid muscle of the upper arm as the preferred vaccination site. The immunization schedule consists of two doses at 0.5 ml per dose, and the second dose shall be administered two months apart from the first dose.
PlaceboBiological
This product is for intramuscular injection only, with the deltoid muscle of the upper arm as the preferred vaccination site. The immunization schedule consists of two doses at 0.5 ml per dose, and the second dose shall be administered two months apart from the first dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: BCHT Recombinant Zoster Vaccine vaccine | Experimental | Not described Receives: Biological: Recombinant Herpes Zoster Vaccine |
| Adjuvant placebo | Placebo comparator | Not described Receives: Biological: adjuvant placebo |
| placebo：Sodium Chloride Injection | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events/Reactions
Measured: 14/30 days after injection
Incidence of adverse events/reactions after administration
Measured: 14days and 30 days after administration
Secondary outcomes (2)
IgG Antibody and VZV antibody
Measured: 15/30 days after full immunization
Cellular immune response
Measured: 15 days after full immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start28 May 2026
- Primary completion28 Dec 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerpesStudies 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633197
- Sponsor's protocol ID
- B2005-F20250120-1
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial for Randomized, Blinded, Placebo-Controlled Evaluation of Safety, Tolerability and Preliminary Exploratory Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cell) With Different Doses in Adults Aged 40 Years and Above
- ClinicalTrials.gov ID
- NCT07633197
- Acronym / sponsor ID
- B2005-F20250120-1
- Conditions
- Herpes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Jun 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.
To evaluate the safety and tolerability of different dosages of recombinant zoster vaccine (CHO cell) when administered to adults aged 40 years and older.
Detailed description
30 days After each dose of vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: BCHT Recombinant Zoster Vaccine vaccine | Experimental | Biological: Recombinant Herpes Zoster Vaccine |
| Adjuvant placebo | Placebo comparator | Biological: adjuvant placebo |
| placebo：Sodium Chloride Injection | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants are aged ≥40 years on the day of enrollment and can provide legal identity documents;
- The participant voluntarily agrees to take part in the trial and is capable of fully understanding and signing the informed consent form;
- The participant is able to comply with the requirements specified in the clinical trial protocol.
Key exclusion criteria (16 listed)
- Axillary body temperature >37.3°C on the day of enrollment*;
- Subjects with a prior history of herpes zoster, or having had close contact with patients with chickenpox/herpes zoster within 30 days prior to enrollment;
- Subjects with previous vaccination history of chickenpox or herpes zoster vaccine;
- Subjects allergic to any component of the investigational vaccine (Varicella-Zoster Virus glycoprotein E, BK-02 adjuvant, dipotassium hydrogen phosphate trihydrate, sodium dihydrogen phosphate monohydrate, sucrose, Polysorbate 80), or with a history of severe hypersensitivity to any drugs or vaccines;
- Confirmed or suspected immunosuppression or immunodeficiency disorders induced by underlying diseases or immunosuppressive/cytotoxic therapies, including but not limited to subjects diagnosed with immunodeficiency diseases, malignant tumors, HIV infection, leukemia, lymphoma, Hodgkin's disease, or compromised immunity resulting from organ and bone marrow transplantation;
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 |
|---|---|---|
| Recombinant Herpes Zoster VaccineThis product is for intramuscular injection only, with the deltoid muscle of the upper arm as the preferred vaccination site. The immunization schedule consists of two doses at 0.5 ml per dose, and the second dose shall be administered two months apart from the first dose. | Biological | Experimental: BCHT Recombinant Zoster Vaccine vaccine |
| adjuvant placeboThis product is for intramuscular injection only, with the deltoid muscle of the upper arm as the preferred vaccination site. The immunization schedule consists of two doses at 0.5 ml per dose, and the second dose shall be administered two months apart from the first dose. | Biological | Adjuvant placebo |
| PlaceboThis product is for intramuscular injection only, with the deltoid muscle of the upper arm as the preferred vaccination site. The immunization schedule consists of two doses at 0.5 ml per dose, and the second dose shall be administered two months apart from the first dose. | Biological | placebo：Sodium Chloride Injection |
Primary outcome
Adverse Events/Reactions
Time frame: 14/30 days after injection
Incidence of adverse events/reactions after administration
Time frame: 14days and 30 days after administration
2 secondary outcomes
IgG Antibody and VZV antibody
Time frame: 15/30 days after full immunization
Cellular immune response
Time frame: 15 days after full immunization
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 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Herpes Zoster Vaccine in people with Herpes, run by Changchun BCHT Biotechnology Co. at 1 site in China.
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 3 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events/Reactions (time frame: 14/30 days after injection). The study lists 2 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 Jun 2026.