Back to resultsA Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years
Primary Purpose
Herpes Zoster
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
One shot of the zoster vaccine
One shot of the varicella vaccine
one shot of placebo
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster focused on measuring VZV
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.
- 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.
Sites / Locations
- Henan Provincial Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Zoster vaccine, Live
Varicella vaccine, Live
Placebo
Arm Description
live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
live attenuated varicella-zoster virus vaccine (with live virus >=3.3 LgPFU per dose)
Placebo with no live virus
Outcomes
Primary Outcome Measures
Reactogenicity in the group of live attenuated zoster vaccine
The incidence rate of subjects with solicited AE(s) with 95% confidence interval
The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
VZV specific serum conversion rate
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.
VZV specific serum geometric mean titre
For each group serum titre with FAMA test
VZV specific serum geometric mean fold increase
For each group serum titre with FAMA test
Secondary Outcome Measures
Reactogenicity in the group of live attenuated varicella vaccine
The incidence rate of subjects with solicited AE(s) with 95% confidence interval
The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Reactogenicity in the group of placebo
The incidence rate of subjects with solicited AE(s) with 95% confidence interval
The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
The immunogenicity persistence of antibody titer
The antibody titer measured by FAMA postvaccination in day 90,180,360
Full Information
NCT ID
NCT04072497
First Posted
August 19, 2019
Last Updated
August 27, 2019
Sponsor
Shanghai Institute Of Biological Products
1. Study Identification
Unique Protocol Identification Number
NCT04072497
Brief Title
A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years
Official Title
A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute Of Biological Products
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
VZV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
522 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zoster vaccine, Live
Arm Type
Experimental
Arm Description
live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
Arm Title
Varicella vaccine, Live
Arm Type
Active Comparator
Arm Description
live attenuated varicella-zoster virus vaccine (with live virus >=3.3 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 zoster vaccine
Intervention Description
One shot of the zoster vaccine (with live virus >=4.3 LgPFU per dose)
Intervention Type
Biological
Intervention Name(s)
One shot of the varicella vaccine
Intervention Description
One shot of the varicella vaccine (with live virus >=3.3 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
Reactogenicity in the group of live attenuated zoster vaccine
Description
The incidence rate of subjects with solicited AE(s) with 95% confidence interval
The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Time Frame
0 days-6 months after the vaccination
Title
VZV specific serum conversion rate
Description
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.
Time Frame
30 days after the vaccination
Title
VZV specific serum geometric mean titre
Description
For each group serum titre with FAMA test
Time Frame
30 days after the vaccination
Title
VZV specific serum geometric mean fold increase
Description
For each group serum titre with FAMA test
Time Frame
30 days after the vaccination
Secondary Outcome Measure Information:
Title
Reactogenicity in the group of live attenuated varicella vaccine
Description
The incidence rate of subjects with solicited AE(s) with 95% confidence interval
The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Time Frame
0 days-6 months after the vaccination
Title
Reactogenicity in the group of placebo
Description
The incidence rate of subjects with solicited AE(s) with 95% confidence interval
The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Time Frame
0 days-6 months after the vaccination
Title
The immunogenicity persistence of antibody titer
Description
The antibody titer measured by FAMA postvaccination in day 90,180,360
Time Frame
90 days-360 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Facility Information:
Facility Name
Henan Provincial Center for Disease Control and Prevention
City
Qixian
State/Province
Henan
ZIP/Postal Code
450016
Country
China
12. IPD Sharing Statement
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A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years
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