A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety, and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Subjects Aged 40 Years and Older
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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-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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:
• 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;
Locations
Other Locations
China
Jiangsu Province Center for Disease Control and Prevention (China)
RECRUITING
Zhenjiang
Contact Information
Primary
Fengcai Zhu, MM
jscdczfc@126.com
13951994867
Backup
Pengfei Jin
kingpfph@sina.com
18852048896
Time Frame
Start Date:2023-09-28
Estimated Completion Date:2026-12-31
Participants
Target number of participants:4
Treatments
Experimental: Treatment main group
11500 subjects in treatment main group will receive 2 doses of LZ901 at D0 and D29. This group will be required to complete a 12 month safety follow-up after full immunization.
Placebo_comparator: Placebo main group
11500 subjects in placebo main group will receive 2 doses of placebo at D0 and D29. This group will be required to complete a 12 month safety follow-up after full immunization.
Experimental: Treatment immunization group
1500 subjects in treatment immunization group will receive 2 doses of LZ901 at D0 and D29. This group is designed to evaluate the batch-batch immunogenicity consistency among three different batches of LZ901, as well as the immunogenicity and immunogenicity persistence of the LZ901 at 36 months after full immunization.
Placebo_comparator: Placebo immunization group
1500 subjects in placebo immunization group will receive 2 doses of placebo at D0 and D29. This group is designed to evaluate the batch-batch immunogenicity consistency among three different batches of LZ901, as well as the immunogenicity and immunogenicity persistence of the LZ901 at 36 months after full immunization.