Herpes Zoster (HZ)Phase 1/2NCT06932523
A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals
A Phase 1/2 study testing Recombinant herpes zoster vaccine with low-dose adjuvant, Recombinant herpes zoster vaccine with high-dose adjuvant and Low-dose adjuvant in people with Herpes Zoster (HZ), run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster (HZ)
- What is being tested?
- Recombinant herpes zoster vaccine with low-dose adjuvant, Recombinant herpes zoster vaccine with high-dose adjuvant and Low-dose adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 645 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2025to 31 Dec 2027
- Phase
- Phase 1/2
- 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 old on the day of enrollment, gender not limited.
- Can provide legal proof of identity.
- Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment.
- Be able to participate in all planned follow-up visits and comply with all trial procedures.
- On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature).
- Chronic disease patients need to be in a stable period of chronic disease.
- Female and male participants of childbearing age agreed to adopt strict and effective contraceptive measures from the start of the trial to 6 months after full exemption.
Who cannot join
- Individuals with a history of herpes zoster in the past.
- Individuals with a history of vaccination against chickenpox or shingles.
- Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years.
- Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period.
- Individuals who are allergic to any component of the vaccine or have a history of other severe allergies.
- Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period.
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- Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior to receiving the experimental vaccine.
- Any experimental or unregistered product (drug, vaccine, biological product or device) other than the experimental vaccine has been used within one month prior to vaccination, or is planned to be used during the trial period.
- Administer non live vaccines within 7 days prior to administering the experimental vaccine or live vaccines within 14 days prior to administering the experimental vaccine.
- Suffering from a serious illness that prevents the completion of the entire experiment.
- Received immunosuppressive therapy or other immunomodulatory drugs, monoclonal antibodies, thymosin, interferon, etc. within 6 months prior to vaccination with the experimental vaccine, or planned to receive such treatment within 1 month after the first dose to full immunization, but local medication is allowed.
- Chemotherapy, radiotherapy, and organ and bone marrow transplantation related treatments for cancer or other diseases.
- Diseases or medical measures that lead to immune dysfunction
- Individuals currently suffering from serious infectious diseases such as active tuberculosis and active viral hepatitis.
- Moderate or severe acute illness/infection, or febrile illness within 72 hours prior to vaccination.
- Known to have a history of thrombocytopenia, any coagulation dysfunction, or being treated with anticoagulants.
- Suffering from serious cardiovascular disease, pulmonary edema, serious liver and kidney disease, and diabetes that cannot be controlled by drugs.
- Previous history of mental and neurological disorders or family history of mental illness.
- Currently suffering from various severe infectious, suppurative, and allergic skin diseases.
- Plan to move before the end of the trial or leave the local area for a long time during the scheduled trial visit.
- (Phase I ) Abnormal blood routine, blood biochemistry, coagulation, and urine routine indicators before vaccination (excluding those judged by doctors to have no clinical significance).
- Any situation that the researcher believes may affect the evaluation of the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei
Yeqing Tong, 027-87652057, 63382251@qq.com
About this study
Official title: Randomized, Blinded, Controlled Phase I/Ⅱ Clinical Trial Evaluating the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) for Healthy Individuals Aged 40 Years and Above
The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).
Read the detailed description
There are two parts of the study.
Substudy A:
This substudy is the Phase I portion of the study. In this substudy, participants will receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or adjuvant controls or normal saline intramuscularly. Participants will be divided into 2 age groups: 40-49 years old and ≥ 50 years old. Participants will receive vaccinations on days 0 and 60. Participants will complete a 12-month safety follow-up after two doses of vaccination, and they will take part in this study for about 14 months.
Substudy B:
This substudy is the Phase Ⅱ portion of the study. In this part of the study, participants will also receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or normal saline intramuscularly. Participants will be divided into 3 age groups: 40-49 years old, 50-69 years old and ≥ 70 years old. Participants will receive vaccinations on days 0 and 60. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants will be involved in this study for up to 2 years.
- Conditions
- Herpes Zoster (HZ)
- Being tested
- Recombinant herpes zoster vaccine with low-dose adjuvant, Recombinant herpes zoster vaccine with high-dose adjuvant, Low-dose adjuvant, High-dose adjuvant, Shingrix (GSK)
- Keywords
- herpes zoster, recombinant herpes zoster vaccine, vaccine, safety, immunogenicity
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant herpes zoster vaccine with low-dose adjuvantBiological
Candidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
Recombinant herpes zoster vaccine with high-dose adjuvantBiological
Candidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Low-dose adjuvantBiological
Adjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule
High-dose adjuvantBiological
Adjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule
Shingrix (GSK)Biological
Positive control, Intramuscular injection, 0, 2 months schedule
Normal SalineBiological
Placebo control, Intramuscular injection, 0, 2 months schedule
| Study group | Role | What they receive |
|---|---|---|
| SubStudy A (SSA): Group 1 | Experimental | Recombinant herpes zoster vaccine with low-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with low-dose adjuvant |
| SSA: Group 2 | Experimental | Recombinant herpes zoster vaccine with high-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with high-dose adjuvant |
| SSA:Control group 1 | Placebo comparator | Low-dose adjuvant Receives: Biological: Low-dose adjuvant |
| SSA:Control group 2 | Placebo comparator | High-dose adjuvant Receives: Biological: High-dose adjuvant |
| SSA: Positive control | Active comparator | Shingrix (GSK) Receives: Biological: Shingrix (GSK) |
| SSA: Placebo group | Placebo comparator | Normal saline Receives: Biological: Normal Saline |
| SubStudy B (SSB): Group 3 | Experimental | Recombinant herpes zoster vaccine with low-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with low-dose adjuvant |
| SSB: Group 4 | Experimental | Recombinant herpes zoster vaccine with high-dose adjuvant Receives: Biological: Recombinant herpes zoster vaccine with high-dose adjuvant |
| SSB: Positive control | Active comparator | Shingrix (GSK) Receives: Biological: Shingrix (GSK) |
| SSB: Placebo group | Placebo comparator | Normal saline Receives: Biological: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of immediate Adverse Events (AEs)
The occurrence of any adverse events within 30 minutes after each dose of vaccination.
Measured: 30min after each dose of vaccination
Percentage of solicited Adverse Events
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Measured: 14 days after each dose of vaccination
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Measured: 12 months after the last dose
Percentage of unsolicited Adverse Events
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Measured: 28 or 30 days after each dose of vaccination
Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies
GMC levels o of Anti-gE Antibodies in participants after receiving 2 doses of vaccine.
Measured: 30 days after the last dose of vaccination
Geometric Mean Titer (GMT) of Anti-VZV Antibodies
GMT levels o of Anti-VZV Antibodies in participants after receiving 2 doses of vaccine.
Measured: 30 days after the last dose of vaccination
Positive rate of Anti-gE Antibodies
The proportion of individuals in the study population who have achieved Anti-gE antibody positive after immunization.
Measured: 30 days after the last dose of vaccination
Positive rate of Anti-VZV Antibodies
The proportion of individuals in the study population who have achieved Anti-VZV antibody positive after immunization.
Measured: 30 days after the last dose of vaccination
Seroconversion rate of Anti-gE Antibodies
The proportion of individuals in the study population who have achieved Anti-gE antibody seroconversion after immunization.
Measured: 30 days after the last dose of vaccination
Seroconversion rate of Anti-VZV Antibodies
The proportion of individuals in the study population who have achieved Anti-VZV antibody seroconversion after immunization.
Measured: 30 days after the last dose of vaccination
Secondary outcomes (2)
SSB： Cellular immune level
Levels of glycoprotein E (gE)-specific CD4+/CD8+ T cells expressing 2 or more markers of activation.
Measured: 30 days, 6 months, 12months and 24 months after the last dose of vaccination
SSB：Humoral immunogenicity level
Levels of GMC (Anti-gE antibody), GMT (Anti-VZV antibody), positive rate and seroconversion rate after receiving 2 doses of vaccine.
Measured: 6 months, 12months and 24 months after the last dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start4 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Zoster (HZ)Studies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 645 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeqing Tong, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932523
- Sponsor's protocol ID
- SIBP-V04-Ⅰ/Ⅱ
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2025
- Last updated
- 7 Jan 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Controlled Phase I/Ⅱ Clinical Trial Evaluating the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) for Healthy Individuals Aged 40 Years and Above
- ClinicalTrials.gov ID
- NCT06932523
- Acronym / sponsor ID
- SIBP-V04-Ⅰ/Ⅱ
- Conditions
- Herpes Zoster (HZ)
- Keywords
- herpes zoster, recombinant herpes zoster vaccine, vaccine, safety, immunogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 645 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Apr 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.
The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).
Detailed description
There are two parts of the study.
Substudy A:
This substudy is the Phase I portion of the study. In this substudy, participants will receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or adjuvant controls or normal saline intramuscularly. Participants will be divided into 2 age groups: 40-49 years old and ≥ 50 years old. Participants will receive vaccinations on days 0 and 60. Participants will complete a 12-month safety follow-up after two doses of vaccination, and they will take part in this study for about 14 months.
Substudy B:
This substudy is the Phase Ⅱ portion of the study. In this part of the study, participants will also receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or normal saline intramuscularly. Participants will be divided into 3 age groups: 40-49 years old, 50-69 years old and ≥ 70 years old. Participants will receive vaccinations on days 0 and 60. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants will be involved in this study for up to 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| SubStudy A (SSA): Group 1 | Experimental | Biological: Recombinant herpes zoster vaccine with low-dose adjuvantRecombinant herpes zoster vaccine with low-dose adjuvant |
| SSA: Group 2 | Experimental | Biological: Recombinant herpes zoster vaccine with high-dose adjuvantRecombinant herpes zoster vaccine with high-dose adjuvant |
| SSA:Control group 1 | Placebo comparator | Biological: Low-dose adjuvantLow-dose adjuvant |
| SSA:Control group 2 | Placebo comparator | Biological: High-dose adjuvantHigh-dose adjuvant |
| SSA: Positive control | Active comparator | Biological: Shingrix (GSK)Shingrix (GSK) |
| SSA: Placebo group | Placebo comparator | Biological: Normal SalineNormal saline |
| SubStudy B (SSB): Group 3 | Experimental | Biological: Recombinant herpes zoster vaccine with low-dose adjuvantRecombinant herpes zoster vaccine with low-dose adjuvant |
| SSB: Group 4 | Experimental | Biological: Recombinant herpes zoster vaccine with high-dose adjuvantRecombinant herpes zoster vaccine with high-dose adjuvant |
| SSB: Positive control | Active comparator | Biological: Shingrix (GSK)Shingrix (GSK) |
| SSB: Placebo group | Placebo comparator | Biological: Normal SalineNormal saline |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 40 years old on the day of enrollment, gender not limited.
- Can provide legal proof of identity.
- Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment.
- Be able to participate in all planned follow-up visits and comply with all trial procedures.
- On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature).
Key exclusion criteria (22 listed)
- Individuals with a history of herpes zoster in the past.
- Individuals with a history of vaccination against chickenpox or shingles.
- Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years.
- Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period.
- Individuals who are allergic to any component of the vaccine or have a history of other severe allergies.
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 vaccine with low-dose adjuvantCandidate 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule | Biological | SubStudy A (SSA): Group 1, SubStudy B (SSB): Group 3 |
| Recombinant herpes zoster vaccine with high-dose adjuvantCandidate 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule | Biological | SSA: Group 2, SSB: Group 4 |
| Low-dose adjuvantAdjuvant control 1, Dose Level 1, Intramuscular injection, 0, 2 months schedule | Biological | SSA:Control group 1 |
| High-dose adjuvantAdjuvant control 2, Dose Level 2, Intramuscular injection, 0, 2 months schedule | Biological | SSA:Control group 2 |
| Shingrix (GSK)Positive control, Intramuscular injection, 0, 2 months schedule | Biological | SSA: Positive control, SSB: Positive control |
| Normal SalinePlacebo control, Intramuscular injection, 0, 2 months schedule | Biological | SSA: Placebo group, SSB: Placebo group |
Primary outcome
Percentage of immediate Adverse Events (AEs)
Time frame: 30min after each dose of vaccination
The occurrence of any adverse events within 30 minutes after each dose of vaccination.
Percentage of solicited Adverse Events
Time frame: 14 days after each dose of vaccination
Adverse events defined by the protocol that occurred to the participant during 0-14 days after each dose of vaccination.
Serious Adverse Events (SAE)
Time frame: 12 months after the last dose
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Percentage of unsolicited Adverse Events
Time frame: 28 or 30 days after each dose of vaccination
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies
Time frame: 30 days after the last dose of vaccination
GMC levels o of Anti-gE Antibodies in participants after receiving 2 doses of vaccine.
Geometric Mean Titer (GMT) of Anti-VZV Antibodies
Time frame: 30 days after the last dose of vaccination
GMT levels o of Anti-VZV Antibodies in participants after receiving 2 doses of vaccine.
Positive rate of Anti-gE Antibodies
Time frame: 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-gE antibody positive after immunization.
Positive rate of Anti-VZV Antibodies
Time frame: 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-VZV antibody positive after immunization.
Seroconversion rate of Anti-gE Antibodies
Time frame: 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-gE antibody seroconversion after immunization.
Seroconversion rate of Anti-VZV Antibodies
Time frame: 30 days after the last dose of vaccination
The proportion of individuals in the study population who have achieved Anti-VZV antibody seroconversion after immunization.
2 secondary outcomes
SSB： Cellular immune level
Time frame: 30 days, 6 months, 12months and 24 months after the last dose of vaccination
SSB：Humoral immunogenicity level
Time frame: 6 months, 12months and 24 months after the last dose of vaccination
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 Jan 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.
Yeqing Tong principal investigator
Hubei Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant herpes zoster vaccine with low-dose adjuvant, Recombinant herpes zoster vaccine with high-dose adjuvant and Low-dose adjuvant in people with Herpes Zoster (HZ), run by Shanghai Institute Of Biological Products 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 7 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 7 Jan 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chaorong Xu (02162800991, xuchaorong@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of immediate Adverse Events (AEs) (time frame: 30min after each dose of vaccination). The study lists 10 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 7 Jan 2026.