> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-recombinant-herpes-zoster-ff3ef996-cf17-4285-80e7-19a0cc0d06e5 > Record changed: 2026-11-04 # Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above NCT05636436 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) Participants 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) Lead sponsor MAXVAX Biotechnology Limited Liability Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) Start date 2022-12-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Title and summary **Summary** The purposes of the study are to evaluate the safety and tolerability of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 18 years and older, and to preliminarily explore immunogenicity. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Short title** Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Official title** A Phase I, Single Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Dates **Completion date** 2025-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **First posted** 2022-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Registry last updated** 2026-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Primary completion date** 2025-05-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Start date** 2022-12-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Size and sites **Actual participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Randomisation ratio** 2:2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Lead sponsor** MAXVAX Biotechnology Limited Liability Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Identifiers **Registry ID** NCT05636436 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **ClinicalTrials.gov ID** NCT05636436 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## 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/NCT05636436) ## Outcomes ### Primary outcomes 1. The incidence and severity of adverse events Timeframe: Within 30 minutes after each vaccination. Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 2. The incidence and severity of adverse events Timeframe: Within 7 days after each vaccination. Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 3. The incidence and severity of adverse events Timeframe: Day 8 to 30 after each vaccination. Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 4. The incidence and severity of adverse events Timeframe: Within 30 days after each vaccination. Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5. 5. Incidence of abnormal and clinically significant laboratory test results Timeframe: Day 4 after each vaccination . Laboratory test includes hematology, blood biochemistry and urine analysis. ### Secondary outcomes 1. Incidence of Serious Adverse Event Timeframe: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420). Incidence of Serious Adverse Event (SAE) from the first vaccination to 12 months after full vaccination. 2. Potential Immune Mediated Disorder Timeframe: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420). Incidence of Potential Immune Mediated Disorder (pIMD) from the first vaccination to 12 months after full vaccination. 3. Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody Timeframe: Prior to each vaccination (Day 0, Day 60). Measured by ELISA. 4. Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody Timeframe: Day 14 after each vaccination (Day 14, Day 74). Measured by ELISA. 5. Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody Timeframe: Month 1 after each vaccination (Day 30, Day 90). Measured by ELISA. 6. Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody Timeframe: Month 6 and 12 after the second vaccination (Day 240, Day 420). Measured by ELISA. 7. Seroconversion rate of anti-gE antibody and anti-VZV antibody Timeframe: Prior to the second vaccination (Day 60). Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was \\37.0℃; 2. History of herpes zoster within 5 years before vaccination; 3. Prior vaccination with chickenpox vaccine or herpes zoster vaccine; 4. Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination; 5. Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination; 6. Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination; 7. Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination; 8. A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination; 9. History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history; 10. Asplenia or functional asplenia, or splenectomy caused by any condition; 11. Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases; 12. Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable; 13. Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication; 14. History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications; 15. Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg); 16. Abnormal and clinically significant laboratory test results as determined by the investigator before vaccination; 17. Current or history of alcohol and/or drug abuse; 18. Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Sites - Yanjin District Center for Disease Control and PreventionXinxiang, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636436) ## Related records ### Drugs (1) - [Varicella zoster virus envelope glycoprotein E](https://trialight.com/data/asset/varicella-zoster-virus-envelope-glycoprotein-e-ff6f0103-e6e7-4f17-9aed-0ca05c8633ef.md) ### Collaborators (1) - Henan Center for Disease Control and Prevention ### Lead sponsors (1) - [MAXVAX Biotechnology Limited Liability Company](https://trialight.com/data/company/maxvax-biotechnology-limited-liability-company-e57374a8-4393-4abe-9d15-ea4174498f1b.md) ### Conditions (1) - [Herpes zoster](https://trialight.com/data/condition/herpes-zoster-b5c04cf4-ae28-5154-8254-f4f1fde4c3c9.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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