Phase
Condition
Shingles
Chickenpox (Varicella Zoster Infection)
Rash
Treatment
Recombinant herpes zoster vaccine with high-dose adjuvant
Recombinant herpes zoster vaccine with low-dose adjuvant
High-dose adjuvant
Clinical Study ID
Ages > 40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 consentform, expressing agreement to participate in the experiment.
Be able to participate in all planned follow-up visits and comply with all trialprocedures.
On the day of enrollment, the body temperature was less than 37.3 ℃ (axillarytemperature).
Chronic disease patients need to be in a stable period of chronic disease.
Female and male participants of childbearing age agreed to adopt strict andeffective contraceptive measures from the start of the trial to 6 months after fullexemption.
Exclusion
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 inthe past 2 years.
Women of childbearing age who have a positive urine pregnancy test, arebreastfeeding, pregnant, or plan to become pregnant within 6 months after the startof the test and the full exemption period.
Individuals who are allergic to any component of the vaccine or have a history ofother severe allergies.
Use immunoglobulin and/or any blood products within 3 months prior to administeringthe trial vaccine, or plan to use them during the trial period.
Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior toreceiving the experimental vaccine.
Any experimental or unregistered product (drug, vaccine, biological product ordevice) other than the experimental vaccine has been used within one month prior tovaccination, or is planned to be used during the trial period.
Administer non live vaccines within 7 days prior to administering the experimentalvaccine or live vaccines within 14 days prior to administering the experimentalvaccine.
Suffering from a serious illness that prevents the completion of the entireexperiment.
Received immunosuppressive therapy or other immunomodulatory drugs, monoclonalantibodies, thymosin, interferon, etc. within 6 months prior to vaccination with theexperimental vaccine, or planned to receive such treatment within 1 month after thefirst dose to full immunization, but local medication is allowed.
Chemotherapy, radiotherapy, and organ and bone marrow transplantation relatedtreatments for cancer or other diseases.
Diseases or medical measures that lead to immune dysfunction
Individuals currently suffering from serious infectious diseases such as activetuberculosis and active viral hepatitis.
Moderate or severe acute illness/infection, or febrile illness within 72 hours priorto vaccination.
Known to have a history of thrombocytopenia, any coagulation dysfunction, or beingtreated with anticoagulants.
Suffering from serious cardiovascular disease, pulmonary edema, serious liver andkidney disease, and diabetes that cannot be controlled by drugs.
Previous history of mental and neurological disorders or family history of mentalillness.
Currently suffering from various severe infectious, suppurative, and allergic skindiseases.
Plan to move before the end of the trial or leave the local area for a long timeduring the scheduled trial visit.
(Phase I ) Abnormal blood routine, blood biochemistry, coagulation, and urineroutine indicators before vaccination (excluding those judged by doctors to have noclinical significance).
Any situation that the researcher believes may affect the evaluation of theexperiment.
Study Design
Study Description
Connect with a study center
Hubei Provincial Center for Disease Control and Prevention
Wuhan 1791247, Hubei 1806949
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.