A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years

Study Overview
=================
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.

Official Title
-----------------
A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years

Conditions
-----------------
Herpes Zoster

Intervention / Treatment
-----------------
* Biological: One shot of the zoster vaccine
* Biological: One shot of the varicella vaccine
* Biological: one shot of placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoster vaccine, Live<br>live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) | Biological: One shot of the zoster vaccine<br>* One shot of the zoster vaccine (with live virus >=4.3 LgPFU per dose)<br>|
| Active Comparator: Varicella vaccine, Live<br>live attenuated varicella-zoster virus vaccine (with live virus >=3.3 LgPFU per dose) | Biological: One shot of the varicella vaccine<br>* One shot of the varicella vaccine (with live virus >=3.3 LgPFU per dose)<br>|
| Placebo Comparator: Placebo<br>Placebo with no live virus | Biological: one shot of placebo<br>* one shot of placebo with no live virus<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0 days-6 months after the vaccination | 
| 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. | 30 days after the vaccination | 
| VZV specific serum geometric mean titre | For each group serum titre with FAMA test | 30 days after the vaccination | 
| VZV specific serum geometric mean fold increase | 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 | 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 | 0 days-6 months after the vaccination | 
| 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 | 0 days-6 months after the vaccination | 
| The immunogenicity persistence of antibody titer | The antibody titer measured by FAMA postvaccination in day 90,180,360 | 90 days-360 days after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VZV