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

Primary Purpose

Vaccine-Preventable Diseases, Herpes Zoster

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant Herpes Zoster Vaccine
Recombinant Herpes Zoster Vaccine Placebo
Sponsored by
Beijing Luzhu Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccine-Preventable Diseases

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jiangsu Province Center for Disease Control and Prevention (China)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Treatment main group

Placebo main group

Treatment immunization group

Placebo immunization group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Solicited AE
Incidence of Solicited AE include site of vaccination (local) and non-site of vaccination (systemic)
Unsolicited AE
Incidence of unsolicited AEs, include all AEs, except solicited AEs reported Days 0~6 after the study intervention.
AE
Incidence of AE refers to any untoward medical occurrence in a subject administered the investigational vaccine.
Adverse Events of Special Interest
Confirmed cases of HZ within 30 days after the first dose and full immunization
Serious Adverse Event
The incidence of all serious adverse events (SAEs)
Anti-GE antibody
Seroconversion rate of anti-GE antibody in three different batches of immunization groups
Geometric Mean Fold Increase
Geometric Mean Fold Increase (GMFI) of anti-GE antibody in three different batches of immunization groups compared with pre-vaccination (day 0)
GMC ratios
GMC ratios of anti-GE antibodies in three different batches of immunization groups

Full Information

First Posted
September 26, 2023
Last Updated
October 12, 2023
Sponsor
Beijing Luzhu Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06088745
Brief Title
A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Luzhu Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
In this study: The participation is voluntary. Before the trial, participants will receive some tests for screening. If qualified, investigators will officially invite them to join this trial. The trial vaccine is LZ901 (100μg/0.5 mL). The placebo, which is aluminum hydroxide adjuvant, has no active drug. Participants will receive one of two as above mentioned. This trial included a protective efficacy test and a batch-to-batch consistency test (immunization subgroup). Approximately 26000 subjects aged 40 years and older will be enrolled. Subjects will be randomized to receive either LZ901 or placebo in which about 3000 subjects will be enrolled into immunization subgroup and randomly receive three different batches LZ901 and one batch placebo at a ratio of 1:1:1:3. The immunization subgroup was 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 12, 24, and 36 months after full immunization. All subjects will receive the LZ901 or Placebo on day 0 and day 29. Subject will have 16 visits, including 5 on-site visits and 11 in-person visits except for subjects in the immunization subgroup who have 24 visits, including 8 on-site visits and 16 in-line visits. The primary objective was to evaluate the Vaccine Efficacy (VE) of LZ901 against herpes zoster, as compared with placebo, after 30 days of full immunization in people 40 years of age and older. The secondary objective was to evaluate the protective efficacy of LZ901, as compared with placebo, against laboratory-confirmed cases of HZ after 30 days of full vaccination in people 40 years of age and older. To evaluate the safety of LZ901. The immunogenicity of LZ901was evaluated (immunization subgroup). To evaluate the batch-to-batch consistency of immunogenicity of three batches of LZ901 in subject aged ≥40 years (immunization subgroup). An exploratory objective was to evaluate the effect of LZ901 on reducing the severity of PHN in HZ subjects ≥40 years old." To evaluate the efficacy of LZ901 compared with placebo in preventing PHN in subjects ≥40 years old with HZ efficacy endpoint. The immunogenicity of LZ901 was evaluated at 12, 24 and 36 months after full immunization in subject ≥40 years old (immunization subgroup).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine-Preventable Diseases, Herpes Zoster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment main group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo main group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Treatment immunization group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo immunization group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Recombinant Herpes Zoster Vaccine
Other Intervention Name(s)
LZ901
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Recombinant Herpes Zoster Vaccine Placebo
Intervention Description
Alumina adjuvant
Primary Outcome Measure Information:
Title
The Vaccine Efficacy
Description
To evaluate the Vaccine Efficacy in the prevention of HZ compared to placebo based on the number of confirmed cases of HZ
Time Frame
30 days after full immunization
Secondary Outcome Measure Information:
Title
Solicited AE
Description
Incidence of Solicited AE include site of vaccination (local) and non-site of vaccination (systemic)
Time Frame
from 0 to 7 days after each dose
Title
Unsolicited AE
Description
Incidence of unsolicited AEs, include all AEs, except solicited AEs reported Days 0~6 after the study intervention.
Time Frame
From 0 to 30 days after each dose
Title
AE
Description
Incidence of AE refers to any untoward medical occurrence in a subject administered the investigational vaccine.
Time Frame
Within 30 minutes after each dose
Title
Adverse Events of Special Interest
Description
Confirmed cases of HZ within 30 days after the first dose and full immunization
Time Frame
From initial dose to 30 days after full immunization
Title
Serious Adverse Event
Description
The incidence of all serious adverse events (SAEs)
Time Frame
From first dose to 12 months after full immunization
Title
Anti-GE antibody
Description
Seroconversion rate of anti-GE antibody in three different batches of immunization groups
Time Frame
30 days after full immunization
Title
Geometric Mean Fold Increase
Description
Geometric Mean Fold Increase (GMFI) of anti-GE antibody in three different batches of immunization groups compared with pre-vaccination (day 0)
Time Frame
30 days after full immunization
Title
GMC ratios
Description
GMC ratios of anti-GE antibodies in three different batches of immunization groups
Time Frame
30 days after full immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengcai Zhu, MM
Phone
13951994867
Email
jscdczfc@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengfei Jin
Phone
18852048896
Email
kingpfph@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu, MM
Organizational Affiliation
Jiangsu Province Center for Disease Control and Prevention (China)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Center for Disease Control and Prevention (China)
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu, MM
Phone
13951994867
Email
jscdczfc@126.com
First Name & Middle Initial & Last Name & Degree
Pengfei Jin
Phone
18852048896
Email
kingpfph@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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