Status:
RECRUITING
A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
Lead Sponsor:
Beijing Luzhu Biotechnology Co., Ltd.
Conditions:
Vaccine-Preventable Diseases
Herpes Zoster
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This clinical trial is to study protective efficacy and safety of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase Ⅲ, randomized, double...
Detailed Description
In this study: 1. The participation is voluntary. 2. Before the trial, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this trial. ...
Eligibility Criteria
Inclusion
- Males and females able to provide legal identity certificate, aged ≥ 40 years inclusive at the time of signing the ICF;
- Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF;
- Female subjects are not pregnant or lactating. Female subjects with childbearing potential should take reliable contraceptive measures, and have no pregnancy and fertility plan within 7 months;
- Axillary temperature ≤ 37.0℃ on the day of enrollment;
- Able to attend all scheduled follow-up visits and able to comply with protocol requirements;
Exclusion
- Subjects who have had herpes zoster within the previous 5 years;
- Previous vaccination against varicella or shingles (including use of a registered product or participation in a clinical trial of varicella or shingles vaccine);
- Hypersensitivity to any of the components of the test vaccine: or prior hypersensitivity to any recombinant vaccine of CHO cell origin \[e.g., recombinant hepatitis B vaccine (CHO cell)\], polysorbate, etc.; or prior history of severe allergy\* to any of the vaccinations;
- \*Severe allergies: anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction), severe urticaria.
- Developed immunodeficiency diseases (congenital or acquired immunodeficiency diseases, human immunodeficiency virus infection) or received immunosuppressive/cytotoxic treatments (cancer chemotherapy, organ transplantation, or treatment planned during a clinical trial in the 6 months prior to vaccination);
- Receiving immunosuppressive therapy (e.g., long-term systemic glucocorticoid application for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day of prednisone or prednisone-equivalent dose) within 3 months prior to vaccination or within 1 month after the planned full course of immunization；
- Received an inactivated or recombinant vaccine or mRNA vaccine within 14 days or any live attenuated vaccine within 28 days prior to vaccination;
- Subjects who are suffering from an acute illness or are in the acute exacerbation phase of a chronic disease within 3 days prior to vaccination;
- History of asplenia or functional asplenia, and asplenia or splenectomy due to any condition;
- Treatment with blood products or globulins within 3 months prior to enrollment, or planned use of such products within 2 months of vaccination;
- Participating in other clinical studies of investigational or un-registered products (drugs, vaccines or devices, etc.), or planning to participate in other clinical studies before the end of this clinical study;
- Significant underlying medical conditions that, in the opinion of the investigator, may prevent completion of the trial (e.g., life-threatening disease that may limit survival to less than 4 years) or any other condition
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06088745
Start Date
September 28 2023
End Date
December 31 2026
Last Update
October 18 2023
Active Locations (1)
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1
Jiangsu Province Center for Disease Control and Prevention (China)
Zhenjiang, Jiangsu, China, 210009