Herpes ZosterPhase 1/2NCT06801509
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine
A Phase 1/2 study testing Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose, Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose and Shingrix® in people with Herpes Zoster, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects 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 Zoster
- What is being tested?
- Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose, Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose and Shingrix®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 10 Oct 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
- Male or female subjects ≥ 40 years of age;
- The subject can and fully understand the trial procedures and voluntarily sign the ICF;
- The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;
- The subject can comply with the requirements of the protocol;
- The axillary temperature of the subject is < 37.0℃ on the day of enrollment;
- Fertile men and women with childbearing potential voluntarily agree to take effective contraceptive measures from the first vaccination to at least 90 days after the last dose of study vaccines.
Who cannot join
- History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;
- Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);
- Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
- History or family history of convulsions, epilepsy, and psychiatric disorders;
- Suffering from serious chronic diseases or in the active stage of chronic diseases, which are evaluated by the investigator to affect the trial observation, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, hypertension that cannot be controlled after drug treatment (subjects 40-59 years of age have systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, and subjects ≥60 years of age have systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg), diabetes with severe complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart disease, respiratory diseases, liver and kidney diseases, and thyroid diseases;
- Primary or secondary immunosuppressive condition, or diagnosed with primary or acquired immunodeficiency disease, human immunodeficiency virus (HIV) infection, etc.
Show all 19Show fewer
- History of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection and venous blood collection;
- Fever (axillary temperature ≥37.3℃) within 3 days before enrollment or systemic antibiotic or antiviral treatment within 7 days;
- Use of antipyretic analgesics or other drugs with antipyretic and analgesic effects, such as acetaminophen and ibuprofen, within 72 h before vaccination.
- Abnormal laboratory test (blood routine, blood biochemistry, urine routine) results that are outside the reference range and clinically significant (only apply to Phase I);
- Those who are pregnant (positive urine pregnancy test) or breast-feeding, or those who plan to become pregnant during the study period;
- Long-term or high-dose corticosteroid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other corticosteroids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination. Short-term or topical use (such as ointments, eye drops, inhalants, intra-articular medications or nasal sprays) of glucocorticoids is permitted;
- Vaccination with non-attenuated vaccines within 14 days before the first dose of study vaccines, or with live-attenuated vaccines within 28 days before the first dose of study vaccines;
- Participation in other clinical trials (drug or vaccine) within 30 days preceding the first dose of study vaccines or planning to participate in other clinical trials before this clinical study is completed;
- Asplenia or functional asplenia;
- Those who are known to have been diagnosed or currently have an infectious disease, including hepatitis B, hepatitis C, syphilis or AIDS;
- Those who have any acute illness or acute onset of chronic illness within 72 hours before the first dose of vaccination;
- Those who have received blood or blood-related products, including immunoglobulins, within 3 months before the first dose of vaccination, or have planned to use them during the study period;
- Subjects deemed by the investigator to have other conditions that render them ineligible to participate in this study, which include but are not limited to those who are incapable of participating in follow-up visits based on the protocol.
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
Dazhu CDC
Dazhou, Sichuan, 635100
Yulin Jing, Doctor, +86-028-85596863, 21820422@qq.com
About this study
Official title: A Randomized, Double-blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Recombinant Herpes Zoster Vaccine in Healthy Adults
The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.
- Conditions
- Herpes Zoster
- Being tested
- Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose, Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose, Placebo control: Saline, Shingrix®, Ganwei®
- 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 (SCTV04C) Low-DoseBiological
Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;
Recombinant Herpes Zoster Vaccine (SCTV04C) High-DoseBiological
Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;
Placebo control: SalineBiological
The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart;
Shingrix®Biological
Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart
Ganwei®Biological
Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60；
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Vaccine Group | Experimental | Not described Receives: Biological: Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose |
| High-Dose Vaccine Group | Experimental | Not described Receives: Biological: Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose |
| Placebo Group | Placebo comparator | Not described Receives: Biological: Placebo control: Saline |
| Shingrix® Group | Active comparator | Not described Receives: Biological: Shingrix® |
| Ganwei® Group | Active comparator | Herpes zoster vaccine, live; Changchun BCHT Receives: Biological: Ganwei® |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase 1: Incidence and intensity of solicited adverse events (AEs)
Measured: within 14 days after each vaccination
phase 1: Incidence and intensity of unsolicited AEs
Measured: within 30 days after each vaccination
phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody
Measured: at 30 days after full vaccination
Secondary outcomes (11)
phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody
Measured: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
phase 1:Frequency and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by intracellular cytokine staining (ICS)
Measured: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs)
Measured: during the study (from the first vaccination to 12 months after full vaccination)
phase 1: Incidence and intensity of abnormal laboratory tests indicators
Measured: 3 days after each vaccination
phase 2: GMI of antigen-specific antibody
Measured: at 30 days after full vaccination
phase 2: GMC, GMI, and seroconversion rate of antigen-specific antibody
Measured: before the second vaccination, and at 6 months, 12 months and 24 months after full vaccination
phase 2: GMT/GMC, GMI, and seroconversion rate of VZV-specific antibody
Measured: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination
phase 2: Frequencies and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by ICS
Measured: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination
phase 2: Incidence and intensity of solicited AEs
Measured: within 14 days after each vaccination
phase 2: Incidence and intensity of unsolicited AEs
Measured: within 30 days after each vaccination
phase 2: Incidence of SAEs and AESIs
Measured: from the first vaccination to 12 months after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801509
- Sponsor's protocol ID
- SCTV04C-X201
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Recombinant Herpes Zoster Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT06801509
- Acronym / sponsor ID
- SCTV04C-X201
- Conditions
- Herpes Zoster
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 30 Jan 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 purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Vaccine Group | Experimental | Biological: Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose |
| High-Dose Vaccine Group | Experimental | Biological: Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose |
| Placebo Group | Placebo comparator | Biological: Placebo control: Saline |
| Shingrix® Group | Active comparator | Biological: Shingrix® |
| Ganwei® Group | Active comparator | Biological: Ganwei®Herpes zoster vaccine, live; Changchun BCHT |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects ≥ 40 years of age;
- The subject can and fully understand the trial procedures and voluntarily sign the ICF;
- The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;
- The subject can comply with the requirements of the protocol;
- The axillary temperature of the subject is < 37.0℃ on the day of enrollment;
Key exclusion criteria (19 listed)
- History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;
- Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);
- Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
- History or family history of convulsions, epilepsy, and psychiatric disorders;
- Suffering from serious chronic diseases or in the active stage of chronic diseases, which are evaluated by the investigator to affect the trial observation, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, hypertension that cannot be controlled after drug treatment (subjects 40-59 years of age have systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, and subjects ≥60 years of age have systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg), diabetes with severe complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart disease, respiratory diseases, liver and kidney diseases, and thyroid diseases;
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 (SCTV04C) Low-DoseRoute of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart; | Biological | Low-Dose Vaccine Group |
| Recombinant Herpes Zoster Vaccine (SCTV04C) High-DoseRoute of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart; | Biological | High-Dose Vaccine Group |
| Placebo control: SalineThe placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart; | Biological | Placebo Group |
| Shingrix®Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart | Biological | Shingrix® Group |
| Ganwei®Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60； | Biological | Ganwei® Group |
Primary outcome
phase 1: Incidence and intensity of solicited adverse events (AEs)
Time frame: within 14 days after each vaccination
phase 1: Incidence and intensity of unsolicited AEs
Time frame: within 30 days after each vaccination
phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody
Time frame: at 30 days after full vaccination
11 secondary outcomes
phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody
Time frame: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
phase 1:Frequency and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by intracellular cytokine staining (ICS)
Time frame: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs)
Time frame: during the study (from the first vaccination to 12 months after full vaccination)
phase 1: Incidence and intensity of abnormal laboratory tests indicators
Time frame: 3 days after each vaccination
phase 2: GMI of antigen-specific antibody
Time frame: at 30 days after full vaccination
phase 2: GMC, GMI, and seroconversion rate of antigen-specific antibody
Time frame: before the second vaccination, and at 6 months, 12 months and 24 months after full vaccination
phase 2: GMT/GMC, GMI, and seroconversion rate of VZV-specific antibody
Time frame: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination
phase 2: Frequencies and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by ICS
Time frame: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination
phase 2: Incidence and intensity of solicited AEs
Time frame: within 14 days after each vaccination
phase 2: Incidence and intensity of unsolicited AEs
Time frame: within 30 days after each vaccination
phase 2: Incidence of SAEs and AESIs
Time frame: from the first vaccination to 12 months after full 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 30 Jan 2025.
Related trials for Herpes Zoster
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
Active, not recruitingPhase 2
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Not yet recruitingPhase 1/2
Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above
Herpes Zoster
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.
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 (SCTV04C) Low-Dose, Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose and Shingrix® in people with Herpes Zoster, run by Sinocelltech Ltd. 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 6 inclusion and 19 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 30 Jan 2025. 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 Dongyang Gao, Doctor (+86-010-58628288-9137, dongyang_gao@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase 1: Incidence and intensity of solicited adverse events (AEs) (time frame: within 14 days after each vaccination). The study lists 3 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 30 Jan 2025.