A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
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
1 other identifier
interventional
4
1 country
1
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2023
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2023
CompletedStudy Start
First participant enrolled
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedOctober 18, 2023
October 1, 2023
1.3 years
September 26, 2023
October 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The Vaccine Efficacy
To evaluate the Vaccine Efficacy in the prevention of HZ compared to placebo based on the number of confirmed cases of HZ
30 days after full immunization
Secondary Outcomes (8)
Solicited AE
from 0 to 7 days after each dose
Unsolicited AE
From 0 to 30 days after each dose
AE
Within 30 minutes after each dose
Adverse Events of Special Interest
From initial dose to 30 days after full immunization
Serious Adverse Event
From first dose to 12 months after full immunization
- +3 more secondary outcomes
Study Arms (4)
Treatment main group
EXPERIMENTAL11500 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 main group
PLACEBO COMPARATOR11500 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.
Treatment immunization group
EXPERIMENTAL1500 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 immunization group
PLACEBO COMPARATOR1500 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.
Interventions
The active ingredient of the recombinant herpes zoster vaccine is varicella-zoster virus glycoprotein E fusion protein expressed in CHO cells by gene recombination technology. The LZ901 cell line carrying this gene is cultured in chemically defined medium. The harvest cell culture is purified by multi-step liquid chromatography. After Low pH incubation and virus removal filter package Nanofiltration inactivation/virus removal process, the bulk containing high-purity recombinant herpes zoster virus glycoprotein E is obtained. Finally, an alumina adjuvant is added to the formulated final product.
Alumina adjuvant
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Province Center for Disease Control and Prevention (China)
Zhenjiang, Jiangsu, 210009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, MM
Jiangsu Province Center for Disease Control and Prevention (China)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 18, 2023
Study Start
September 28, 2023
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2026
Last Updated
October 18, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share