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

Shanghai Institute Of Biological Products

Status and phase: Completed; Phase 2; Phase 1

Conditions: Herpes Zoster

Treatments: Biological: One shot of the varicella vaccine; Biological: One shot of the zoster vaccine; Biological: one shot of placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04072497

2017L04524-Ⅰ/Ⅱ

Details and patient eligibility

About

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.

Enrollment: 522 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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522 participants in 3 patient groups, including a placebo group

Zoster vaccine, Live

Experimental group

Description:

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

Treatment:

Biological: One shot of the zoster vaccine

Varicella vaccine, Live

Active Comparator group

Description:

live attenuated varicella-zoster virus vaccine (with live virus \>=3.3 LgPFU per dose)

Treatment:

Biological: One shot of the varicella vaccine

Placebo

Placebo Comparator group

Description:

Placebo with no live virus

Treatment:

Biological: one shot of placebo