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

NCT03314103 | Completed Phase 3

• 1 other identifier: CS-HZ-2017
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• The incidence of herpes zoster 30 days after vaccination.

  The incidence of herpes zoster diagnosed in participants 30 days after vaccination.

  30 days-2 years after the vaccination

Secondary Outcomes (12)

• The incidence of herpes zoster after vaccination.

  within 0 day -2 years after the vaccination

• The incidence of laboratory-confirmed herpes zoster 30 days after vaccination.

  30 days-2 years after the vaccination

• The incidence of herpes zoster with severe postherpetic neuralgia (ZBPI scores≥3) 30 days after vaccination.

  30 days-2 years after the vaccination

• The incidence of herpes zoster with postherpetic neuralgia 30 days after vaccination.

  30 days-2 years after the 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

  The incidence of herpes zoster with severe pain (ZBPI scores≥3) in participants 30 days after vaccination.

Study Arms (2)

Vaccine

EXPERIMENTAL

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

Biological: One shot of the varicella-zoster virus vaccine

Placebo

PLACEBO COMPARATOR

Placebo with no live virus

Biological: one shot of placebo

Interventions

One shot of the varicella-zoster virus vaccine BIOLOGICAL

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

Vaccine

one shot of placebo BIOLOGICAL

one shot of placebo with no live virus

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (3)

Hunan Provincial Center for Disease Control and Prevention

Loudi, Hunan, 417000, China

Location

Jiangsu Province Centers for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Zhejiang Provincial Center for Disease Control and Prevention

Hanzhou, Zhejiang, 310051, China

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: October 14, 2017
• First Posted: October 19, 2017
• Study Start: October 6, 2017
• Primary Completion: January 19, 2019
• Study Completion: January 19, 2019
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)