Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age

NCT ID: NCT03314103

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-06
• Study Completion Date: 2019-01-19

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Vaccine

live attenuated varicella-zoster virus vaccine (with live virus \>=4.3 LgPFU per dose)

Group Type: EXPERIMENTAL

One shot of the varicella-zoster virus vaccine

Intervention Type: BIOLOGICAL

One shot of the live attenuated varicella-zoster virus vaccine (with live virus \>=4.3 LgPFU per dose)

Placebo

Placebo with no live virus

Group Type: PLACEBO_COMPARATOR

one shot of placebo

Intervention Type: BIOLOGICAL

one shot of placebo with no live virus

Interventions

One shot of the varicella-zoster virus vaccine

One shot of the live attenuated varicella-zoster virus vaccine (with live virus \>=4.3 LgPFU per dose)

Intervention Type: BIOLOGICAL

one shot of placebo

one shot of placebo with no live virus

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Fengcai Zhu

Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hunan Provincial Center for Disease Control and Prevention

Loudi, Hunan, China

Jiangsu Province Centers for Disease Control and Prevention

Nanjing, Jiangsu, China

Zhejiang Provincial Center for Disease Control and Prevention

Hanzhou, Zhejiang, China

Countries

China

Other Identifiers

CS-HZ-2017

Identifier Type: -

Identifier Source: org_study_id