Back to resultsEfficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
One shot of the varicella-zoster virus vaccine
one shot of placebo
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster
Eligibility Criteria
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.
Sites / Locations
- Hunan Provincial Center for Disease Control and Prevention
- Jiangsu Province Centers for Disease Control and Prevention
- Zhejiang Provincial Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vaccine
Placebo
Arm Description
live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
Placebo with no live virus
Outcomes
Primary Outcome Measures
The incidence of herpes zoster 30 days after vaccination.
The incidence of herpes zoster diagnosed in participants 30 days after vaccination.
Secondary Outcome Measures
The incidence of herpes zoster after vaccination.
The incidence of herpes zoster diagnosed in participants after vaccination.
The incidence of laboratory-confirmed herpes zoster 30 days after vaccination.
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days after vaccination.
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) 30 days after vaccination.
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) in participants 30 days after vaccination.
The incidence of herpes zoster with postherpetic neuralgia 30 days after vaccination.
The incidence of herpes zoster with postherpetic neuralgia in participants 30 days after 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
30 days-2 years after the vaccination
Geometric mean titre, geometric mean fold increase and four-fold increase rate of serum for antibody responses 30 days post-vaccination.
Geometric mean titre, geometric mean fold increase and four-fold increase rate of Serum for antibody responses at day 30 post-vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 6 months post-vaccination.
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 12 months post-vaccination.
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 12 months post-vaccination
Geometric mean titre, geometric mean fold increase of serum for antibody responses 24 months post-vaccination.
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 24 months post-vaccination
Occurrence of solicited adverse reactions after the vaccination.
Occurrence of solicited adverse reactions within 14 days after the vaccination.
Occurrence of adverse reactions after the vaccination.
Occurrence of adverse reactions within 30 days after the vaccination.
Occurrence of severe adverse reactions after the vaccination.
Occurrence of severe adverse reactions within 2 years after the vaccination.
Full Information
NCT ID
NCT03314103
First Posted
October 14, 2017
Last Updated
March 28, 2021
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT03314103
Brief Title
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
January 19, 2019 (Actual)
Study Completion Date
January 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Experimental
Arm Description
live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo with no live virus
Intervention Type
Biological
Intervention Name(s)
One shot of the varicella-zoster virus vaccine
Intervention Description
One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
Intervention Type
Biological
Intervention Name(s)
one shot of placebo
Intervention Description
one shot of placebo with no live virus
Primary Outcome Measure Information:
Title
The incidence of herpes zoster 30 days after vaccination.
Description
The incidence of herpes zoster diagnosed in participants 30 days after vaccination.
Time Frame
30 days-2 years after the vaccination
Secondary Outcome Measure Information:
Title
The incidence of herpes zoster after vaccination.
Description
The incidence of herpes zoster diagnosed in participants after vaccination.
Time Frame
within 0 day -2 years after the vaccination
Title
The incidence of laboratory-confirmed herpes zoster 30 days after vaccination.
Description
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days after vaccination.
Time Frame
30 days-2 years after the vaccination
Title
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) 30 days after vaccination.
Description
The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) in participants 30 days after vaccination.
Time Frame
30 days-2 years after the vaccination
Title
The incidence of herpes zoster with postherpetic neuralgia 30 days after vaccination.
Description
The incidence of herpes zoster with postherpetic neuralgia in participants 30 days after vaccination.
Time Frame
30 days-2 years after the vaccination
Title
The incidence of herpes zoster with severe pain (ZBPI scores≥3) 30 days after vaccination. Time Frame: 30 days-2 years after the vaccination
Description
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.
Title
Geometric mean titre, geometric mean fold increase and four-fold increase rate of serum for antibody responses 30 days post-vaccination.
Description
Geometric mean titre, geometric mean fold increase and four-fold increase rate of Serum for antibody responses at day 30 post-vaccination
Time Frame
30 days after the vaccination
Title
Geometric mean titre, geometric mean fold increase of serum for antibody responses 6 months post-vaccination.
Description
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination
Time Frame
6 months after the vaccination
Title
Geometric mean titre, geometric mean fold increase of serum for antibody responses 12 months post-vaccination.
Description
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 12 months post-vaccination
Time Frame
12 months after the vaccination
Title
Geometric mean titre, geometric mean fold increase of serum for antibody responses 24 months post-vaccination.
Description
geometric mean titre, geometric mean fold increase of Serum for antibody responses at 24 months post-vaccination
Time Frame
24 months after the vaccination
Title
Occurrence of solicited adverse reactions after the vaccination.
Description
Occurrence of solicited adverse reactions within 14 days after the vaccination.
Time Frame
within 14 days after the vaccination
Title
Occurrence of adverse reactions after the vaccination.
Description
Occurrence of adverse reactions within 30 days after the vaccination.
Time Frame
within 30 days after the vaccination
Title
Occurrence of severe adverse reactions after the vaccination.
Description
Occurrence of severe adverse reactions within 2 years after the vaccination.
Time Frame
within 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hunan Provincial Center for Disease Control and Prevention
City
Loudi
State/Province
Hunan
ZIP/Postal Code
417000
Country
China
Facility Name
Jiangsu Province Centers for Disease Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Zhejiang Provincial Center for Disease Control and Prevention
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310051
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
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