- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04072497
A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years
December 24, 2023 updated by: Shanghai Institute Of Biological Products
A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years
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.
Most people 40 years of age or older had evidence of previous VZV infection.
This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine.
The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd.
The safety and immunogenicity of the zoster vaccine is evaluated.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
522
Phase
- Phase 2
- Phase 1
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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Henan
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Qixian, Henan, China, 450016
- Henan 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
38 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy volunteers aged over 40 years (male or female).
- Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
- Able to understand the content of informed consent and willing to sign the informed consent.
- Able to complete the diary card independently.
- Patients with chronic diseases need to be in a stable period.
- Axillary temperature ≤37.0°C.
Exclusion Criteria:
- Prior history of herpes zoster.
- Prior history of vaccination with herpes zoster vaccine or chickenpox vaccine.
- History of allergic disease likely to be exacerbated by any component of the vaccine.
- Taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period.
- Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period.
- Participation in another research study involving receipt of an investigational product in the last 30 days.
- Prior administration of live vaccine in last 30 days.
- Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
- History of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
- Taking immunosuppressive therapy in last 6 months.
- Any autoimmune disease or immunodeficient state, autoimmune disease or immunodeficient disease.
- Active tuberculosis patient.
- Acute or chronic infections at the vaccination day (axillary temperature≥ 38.0°C).
- Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
- Woman who is breast-feeding.
- Previous history of mental and neurological diseases (e.g. depression, epilepsy or convulsion)
- Planned to move before the end of the study or leave the country for a long time during the scheduled study visit.
- Abnormal Blood Routine and Biochemical Indexes before Inoculation (except for minor abnormalities that are not clinically significant as judged by doctors)
- Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zoster vaccine, Live
live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
|
One shot of the zoster vaccine (with live virus >=4.3 LgPFU per dose)
|
Active Comparator: Varicella vaccine, Live
live attenuated varicella-zoster virus vaccine (with live virus >=3.3 LgPFU per dose)
|
One shot of the varicella vaccine (with live virus >=3.3 LgPFU per dose)
|
Placebo Comparator: Placebo
Placebo with no live virus
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one shot of placebo with no live virus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reactogenicity in the group of live attenuated zoster vaccine
Time Frame: 0 days-6 months after the vaccination
|
|
0 days-6 months after the vaccination
|
VZV specific serum conversion rate
Time Frame: 30 days after the vaccination
|
VZV specific serum conversion is defined as: if serum antibody titer before immunization was less than 1: 8, and antibody titer after immunization was ≥ 1: 8. Or the antibody titer before immunization was≥1:8, and the antibody titer after immunization≥4-fold increase.
|
30 days after the vaccination
|
VZV specific serum geometric mean titre
Time Frame: 30 days after the vaccination
|
For each group serum titre with FAMA test
|
30 days after the vaccination
|
VZV specific serum geometric mean fold increase
Time Frame: 30 days after the vaccination
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For each group serum titre with FAMA test
|
30 days after the vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reactogenicity in the group of live attenuated varicella vaccine
Time Frame: 0 days-6 months after the vaccination
|
|
0 days-6 months after the vaccination
|
Reactogenicity in the group of placebo
Time Frame: 0 days-6 months after the vaccination
|
|
0 days-6 months after the vaccination
|
The immunogenicity persistence of antibody titer
Time Frame: 90 days-360 days after vaccination
|
The antibody titer measured by FAMA postvaccination in day 90,180,360
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90 days-360 days after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
November 20, 2018
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 27, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Estimated)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 24, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017L04524-Ⅰ/Ⅱ
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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