Trials Sponsors Conditions Drugs Pricing

Conditions

Herpes Zoster Vaccine-Preventable Diseases

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

EXPERIMENTAL

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.

Biological: Recombinant Herpes Zoster Vaccine

Placebo main group

PLACEBO COMPARATOR

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.

Biological: Recombinant Herpes Zoster Vaccine Placebo

Treatment immunization group

EXPERIMENTAL

Interventions

Recombinant Herpes Zoster VaccineBiological

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.

Also known as: LZ901

Treatment immunization groupTreatment main group

Recombinant Herpes Zoster Vaccine Placebo

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

Beijing Luzhu Biotechnology Co., Ltd.
Otherlead

Study Sites (1)

Jiangsu Province Center for Disease Control and Prevention (China)

Zhenjiang, Jiangsu, 210009, China

RECRUITING

Fengcai Zhu, MMCONTACT13951994867 jscdczfc@126.com

Pengfei JinCONTACT18852048896 kingpfph@sina.com

MeSH Terms

Conditions

Vaccine-Preventable DiseasesHerpes Zoster

Condition Hierarchy (Ancestors)

InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus Diseases

Study Officials

Fengcai Zhu, MM
Jiangsu Province Center for Disease Control and Prevention (China)
PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengcai Zhu, MM

CONTACT

13951994867 jscdczfc@126.com

Pengfei Jin

CONTACT

18852048896

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

Actual (reported)

Primary Completion

December 31, 2024

Estimated (date passed)

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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (4)

Treatment main group

Placebo main group

Treatment immunization group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Placebo immunization group

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (4)

Treatment main group

Placebo main group

Treatment immunization group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Placebo immunization group

You may not qualify if:

Data Sharing

Source record

Locations