A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Vaccine-Preventable Diseases, Herpes Zoster

In brief

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-blind, placebo-controlled in healthy people aged 40 years and older. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 26000 participators who will receive two-dose injection at the upper arm. LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide.

Key facts

Study ID: NCT06088745
Run by: Beijing Luzhu Biotechnology Co., Ltd.
People needed: 4
Starts: 2023-09-28
Expected to finish: 2026-12-31
Last updated by the study team: 2023-10-18

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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;

You may not qualify if…

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

Where it is running

Jiangsu Province Center for Disease Control and Prevention (China) — Zhenjiang, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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