- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334577
Study on Efficacy of Attenuated Zoster Vaccine, Live
December 6, 2021 updated by: Changchun BCHT Biotechnology Co.
Evaluation of the Efficacy of Attenuated Zoster Vaccine, Live From Herpes Zoster in Adults Aged 40 Years or older---a Multicenter, Randomized, Double-blinded,Placebo-controlled Trial Phase III
Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.
Primary infection is manifested as varicella (chickenpox) , whereas reactivation of latent VZV results in a localized eruption known as herpes zoster.
The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co.
It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial .
The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.
Primary infection is manifested as varicella (chickenpox) , whereas reactivation of latent VZV results in a localized eruption known as herpes zoster.
The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co.
It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial .
The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.
Study Type
Interventional
Enrollment (Actual)
25000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Jiangsu Province Center for Disease Control and Prevention
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Zhejiang
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Hanzhou, Zhejiang, China, 310051
- Zhejiang Provincial Center for Disease Control and Prevention
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 01 Healthy volunteers aged 40 years or older;
- 02 Able to understand and give informed consent;.
- 03 Able to comply with requirements of all clinical trial protocol for completing the study;
- 04 Axillary temperature ≤37.0 at the time of enrollment;
Exclusion Criteria:
- 05 History of herpes zoster;
- 06 History of vaccination against herpes zoster or varicella ;
- 07 Allergic sensitivity to any of the components (including neomycin) in the study vaccine and a history of severe allergies to other vaccine;
- 08 Premenopausal with positive pregnancy test, pregnant or lactating female, or female planning to become pregnant within 6 months;
- 09 Subjects with congenital history of immunity deficiency (e.g., primary immunoglobulin deficiency, isolated IgA deficiency, etc.) or family history;
- 10 Receipt of immunoglobulins and/or any blood products within the 5 months preceding of study vaccine or planning to receive these products during the study period;
- 11 Immunosuppression resulting from disease,such as immunodeficiency, malignant tumor, HIV infection, organ and bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease caused by low immunity; Receipt of immunosuppressive therapy with corticosteroids (except intermittent topical or inhaled corticosteroids [< 800 g/ d Beclomethasone or equivalent]); Other immunosuppressive/cytotoxic treatments (cancer chemotherapy or organ transplantation);
- 12 Subjects with acute infections (such as mumps, etc.), chronic infections in the acute phase (such as active untreated tuberculosis, etc.) or any advanced immune disease;
- 13 Use of any investigational or non-registered product (drug, biological product or device) other than the study vaccine within 1 month before study vaccination , or planed use during the study period;
- 14 Administration or planned administration of any other immunizations within 1 month before study vaccination or scheduled within the study period after study vaccination.
- 15 Any non-local antiviral active treatment within 1 month prior to vaccination, including but not limited to acyclovir, famciclovir, valacyclovir and ganciclovir;
- 16 Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and diflunisal, or going to take these medicine during the study period.
- 17 history of thrombocytopenia or coagulation disorders that may cause subcutaneous injection contraindications;
- 18 significant diseases or significant underlying diseases (such as pulmonary heart disease, pulmonary edema, hypertension that cannot be effectively controlled with drugs [systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg] that may interfere with or hinder the completion of the study, serious liver and kidney diseases, diabetes with concurrent symptoms, etc.);
- 19 Various infectious, suppurative and allergic skin diseases;
- 20 History of psychiatric and neurological disorders (e.g., depression, epilepsy or convulsion);
- 21 Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.(e.g., malleable psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss, and other conditions that may interfere with study evaluation).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Attenuated Zoster Vaccine, Live
One shot of the vaccine (with live viruses titer >=4.3 LgPFU per dose)
|
subcutaneous injection
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Placebo Comparator: Placebo
one shot of placebo with no live virus
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subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of herpes zoster 30 days to 13 months after vaccination
Time Frame: 30 days - 13 months after the vaccination
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The incidence of herpes zoster diagnosed in participants 30 days to 13 months after vaccination
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30 days - 13 months after the vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of herpes zoster after vaccination
Time Frame: 0 day-13 months after the vaccination
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The incidence of herpes zoster diagnosed in participants after vaccination.
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0 day-13 months after the vaccination
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The incidence of laboratory-confirmed herpes zoster 30 days to 13 months after vaccination
Time Frame: 30 days- 13 months after the vaccination
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The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days to 13 months after vaccination.
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30 days- 13 months after the vaccination
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Occurrence of solicited adverse reactions after the vaccination
Time Frame: within 14 days after the vaccination
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Occurrence of solicited adverse reactions within 14 days after the vaccination.
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within 14 days after the vaccination
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Occurrence of adverse reactions after the vaccination.
Time Frame: within 42 days after the vaccination
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Occurrence of adverse reactions within 42 days after the vaccination.
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within 42 days after the vaccination
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Occurrence of severe adverse reactions after the vaccination
Time Frame: within 13 months after the vaccination
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Occurrence of severe adverse reactions within 13 months after the vaccination
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within 13 months after the vaccination
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Geometric mean titre of serum for antibody responses 42 days post-vaccination
Time Frame: 42 days after the vaccination
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Geometric mean titre of Serum for antibody responses at day 42 post-vaccination
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42 days after the vaccination
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Geometric mean fold increase of serum for antibody responses 42 days post-vaccination
Time Frame: 42 days after the vaccination
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Geometric mean fold increase of Serum for antibody responses at day 42 post-vaccination
|
42 days after the vaccination
|
Four-fold increase rate of serum for antibody responses 42 days post-vaccination
Time Frame: 42 days after the vaccination
|
Four-fold increase rate of Serum for antibody responses at 42 day post-vaccination
|
42 days after the vaccination
|
Geometric mean titre of serum for antibody responses 6 months post-vaccination
Time Frame: 6 months after the vaccination
|
Geometric mean titre of Serum for antibody responses at 6 months post-vaccination
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6 months after the vaccination
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Geometric mean fold increase of serum for antibody responses 6 months post-vaccination
Time Frame: 6 months after the vaccination
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Geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination
|
6 months after the vaccination
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Four-fold increase rate of serum for antibody responses 6 months post-vaccination
Time Frame: 6 months after the vaccination
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Four-fold increase rate of Serum for antibody responses at 6 months post-vaccination
|
6 months after the vaccination
|
Geometric mean titre of serum for antibody responses 13 months post-vaccination.
Time Frame: 13 months after the vaccination
|
Geometric mean titre of Serum for antibody responses at 13 months post-vaccination
|
13 months after the vaccination
|
Geometric mean fold increase of serum for antibody responses 13 months post-vaccination.
Time Frame: 13 months after the vaccination
|
Geometric mean fold increase of Serum for antibody responses at 13 months post-vaccination
|
13 months after the vaccination
|
Four-fold increase rate of serum for antibody responses 13 months post-vaccination.
Time Frame: 13 months after the vaccination
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Four-fold increase rate of Serum for antibody responses at 13 months post-vaccination
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13 months after the vaccination
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of postherpetic neuralgia (PHN)30 days to 13 months after vaccination
Time Frame: 30 days -13 months after the vaccination
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The incidence of postherpetic neuralgia (PHN)diagnosed 30 days to 13 months after vaccination
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30 days -13 months after the vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fengcai Zhu, Master, LocationJiangsu Province Center for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2020
Primary Completion (Actual)
July 18, 2021
Study Completion (Actual)
July 18, 2021
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
April 2, 2020
First Posted (Actual)
April 6, 2020
Study Record Updates
Last Update Posted (Actual)
December 8, 2021
Last Update Submitted That Met QC Criteria
December 6, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F20190717
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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