> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-of-recombinant-herpes-zoster-fc877502-f051-4555-95c4-eddaa705efa7 > Record changed: 2026-10-13 # A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals NCT06932523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) Participants 645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) Lead sponsor Shanghai Institute Of Biological Products Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) Start date 2025-04-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Short title** A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Dates **Completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **First posted** 2025-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Registry last updated** 2026-01-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Primary completion date** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Start date** 2025-04-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Size and sites **Participants** 645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Planned participants** 645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Lead sponsor** Shanghai Institute Of Biological Products Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Identifiers **Registry ID** NCT06932523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **ClinicalTrials.gov ID** NCT06932523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Outcomes ### Primary outcomes 1. Percentage of immediate Adverse Events (AEs) Timeframe: 30min after each dose of vaccination The occurrence of any adverse events within 30 minutes after each dose of vaccination. 2. Percentage of solicited Adverse Events Timeframe: 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. 3. Serious Adverse Events (SAE) Timeframe: 12 months after the last dose That is serious adverse events, any serious adverse events that occurred to the participant during the study period. 4. Percentage of unsolicited Adverse Events Timeframe: 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. 5. Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies Timeframe: 30 days after the last dose of vaccination GMC levels o of Anti-gE Antibodies in participants after receiving 2 doses of vaccine. 6. Geometric Mean Titer (GMT) of Anti-VZV Antibodies Timeframe: 30 days after the last dose of vaccination GMT levels o of Anti-VZV Antibodies in participants after receiving 2 doses of vaccine. 7. Positive rate of Anti-gE Antibodies Timeframe: 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. 8. Positive rate of Anti-VZV Antibodies Timeframe: 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. 9. Seroconversion rate of Anti-gE Antibodies Timeframe: 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. 10. Seroconversion rate of Anti-VZV Antibodies Timeframe: 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. ### Secondary outcomes 1. SSB： Cellular immune level Timeframe: 30 days, 6 months, 12months and 24 months after the last dose of vaccination Levels of glycoprotein E (gE)-specific CD4+/CD8+ T cells expressing 2 or more markers of activation. 2. SSB：Humoral immunogenicity level Timeframe: 6 months, 12months and 24 months after the last dose of vaccination Levels of GMC (Anti-gE antibody), GMT (Anti-VZV antibody), positive rate and seroconversion rate after receiving 2 doses of vaccine. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** Yes ### Inclusion criteria - 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. ### Exclusion criteria - 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. - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Sites - Hubei Provincial Center for Disease Control and PreventionWuhan, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06932523) ## Related records ### Drugs (3) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) - [Varicella zoster virus envelope glycoprotein E](https://trialight.com/data/asset/varicella-zoster-virus-envelope-glycoprotein-e-ff6f0103-e6e7-4f17-9aed-0ca05c8633ef.md) ### Lead sponsors (1) - [Shanghai Institute Of Biological Products](https://trialight.com/data/company/shanghai-institute-of-biological-products-47ce571f-b25c-4e8a-a146-48b2b23c0b2a.md) ### Conditions (1) - [Herpes zoster](https://trialight.com/data/condition/herpes-zoster-b5c04cf4-ae28-5154-8254-f4f1fde4c3c9.md) Primary condition ### Targets (3) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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