- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314103
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
March 28, 2021 updated by: Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
A Multi-center, Randomized, Double-blinded, Phase 3 Trial to Evaluate the Efficacy Against Herpes Zoster of a Live Attenuated Varicella-Zoster Virus Vaccine in Adults Over 40 Years of Age
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.
More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection.
This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine.
The investigational vaccines are produced by Changchun Changsheng biotechnology co.
LTD.
The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination.
And the safety of the varicella-zoster virus vaccine is also evaluated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30000
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
-
-
Hunan
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Loudi, Hunan, China, 417000
- Hunan Provincial Center for Disease Control And Prevention
-
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Jiangsu Province Centers for Disease Control and Prevention
-
-
Zhejiang
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Hanzhou, Zhejiang, China, 310051
- Zhejiang Provincial Center for Disease Control and Prevention
-
-
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:
- 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.
- For females only (40-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
- 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 attenuated vaccine in last 28 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>37.0°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.
- 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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo with no live virus
|
one shot of placebo with no live virus
|
Experimental: Vaccine
live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
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One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of herpes zoster 30 days after vaccination.
Time Frame: 30 days-2 years after the vaccination
|
The incidence of herpes zoster diagnosed in participants 30 days after vaccination.
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30 days-2 years after the vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of herpes zoster after vaccination.
Time Frame: within 0 day -2 years after the vaccination
|
The incidence of herpes zoster diagnosed in participants after vaccination.
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within 0 day -2 years after the vaccination
|
The incidence of laboratory-confirmed herpes zoster 30 days after vaccination.
Time Frame: 30 days-2 years after the vaccination
|
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days after vaccination.
|
30 days-2 years after the vaccination
|
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) 30 days after vaccination.
Time Frame: 30 days-2 years after the vaccination
|
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) in participants 30 days after vaccination.
|
30 days-2 years after the vaccination
|
The incidence of herpes zoster with postherpetic neuralgia 30 days after vaccination.
Time Frame: 30 days-2 years after the vaccination
|
The incidence of herpes zoster with postherpetic neuralgia in participants 30 days after vaccination.
|
30 days-2 years after the vaccination
|
The incidence of herpes zoster with severe pain (ZBPI scores≥3) 30 days after vaccination. Time Frame: 30 days-2 years after the vaccination
Time Frame: The incidence of herpes zoster with severe pain (ZBPI scores≥3) in participants 30 days after vaccination.
|
30 days-2 years after the vaccination
|
The incidence of herpes zoster with severe pain (ZBPI scores≥3) in participants 30 days after vaccination.
|
Geometric mean titre, geometric mean fold increase and four-fold increase rate of serum for antibody responses 30 days post-vaccination.
Time Frame: 30 days after the vaccination
|
Geometric mean titre, geometric mean fold increase and four-fold increase rate of Serum for antibody responses at day 30 post-vaccination
|
30 days after the vaccination
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Geometric mean titre, geometric mean fold increase of serum for antibody responses 6 months post-vaccination.
Time Frame: 6 months after the vaccination
|
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination
|
6 months after the vaccination
|
Geometric mean titre, geometric mean fold increase of serum for antibody responses 12 months post-vaccination.
Time Frame: 12 months after the vaccination
|
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 12 months post-vaccination
|
12 months after the vaccination
|
Geometric mean titre, geometric mean fold increase of serum for antibody responses 24 months post-vaccination.
Time Frame: 24 months after the vaccination
|
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 24 months post-vaccination
|
24 months after the vaccination
|
Occurrence of solicited adverse reactions after the vaccination.
Time Frame: within 14 days after the vaccination
|
Occurrence of solicited adverse reactions within 14 days after the vaccination.
|
within 14 days after the vaccination
|
Occurrence of adverse reactions after the vaccination.
Time Frame: within 30 days after the vaccination
|
Occurrence of adverse reactions within 30 days after the vaccination.
|
within 30 days after the vaccination
|
Occurrence of severe adverse reactions after the vaccination.
Time Frame: within 2 years
|
Occurrence of severe adverse reactions within 2 years after the vaccination.
|
within 2 years
|
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)
October 6, 2017
Primary Completion (Actual)
January 19, 2019
Study Completion (Actual)
January 19, 2019
Study Registration Dates
First Submitted
October 14, 2017
First Submitted That Met QC Criteria
October 18, 2017
First Posted (Actual)
October 19, 2017
Study Record Updates
Last Update Posted (Actual)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 28, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS-HZ-2017
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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