A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals
- 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).
- Short title
- A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-31
- First posted
- 2025-04-17
- Registry last updated
- 2026-01-07
- Primary completion date
- 2026-06-30
- Start date
- 2025-04-04
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Institute Of Biological Products
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06932523
- ClinicalTrials.gov ID
- NCT06932523
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 40 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Hubei Provincial Center for Disease Control and PreventionWuhan, ChinaRecruiting
Related records
Drugs (3)
Lead sponsors (1)
Conditions (1)
- Herpes zoster Primary condition