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

Launched by BEIJING LUZHU BIOTECHNOLOGY CO., LTD. · Oct 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called LZ901, which aims to protect adults aged 40 and older from shingles, a painful skin rash caused by the varicella zoster virus. The trial is in its final phase and involves about 26,000 healthy participants who will receive two injections in their upper arm. The vaccine uses a special ingredient to help boost the body’s immune response, which is how vaccines help prevent diseases.

To participate, individuals must be at least 40 years old, able to understand the study and agree to take part. However, certain people cannot join, such as those who have had shingles recently or received similar vaccines before. Participants will have follow-up visits to monitor their health after receiving the vaccine. This trial is crucial for understanding how well the vaccine works and ensuring its safety for future use in preventing shingles.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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