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

NCT04072497 | Completed Phase 1

• 1 other identifier: 2017L04524-Ⅰ/Ⅱ
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

VZV

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Reactogenicity in the group of live attenuated varicella vaccine

  0 days-6 months after the vaccination

• Reactogenicity in the group of placebo

  0 days-6 months after the vaccination

• The immunogenicity persistence of antibody titer

  90 days-360 days after vaccination

Study Arms (3)

Zoster vaccine, Live

EXPERIMENTAL

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

Biological: One shot of the zoster vaccine

Varicella vaccine, Live

ACTIVE COMPARATOR

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

Biological: One shot of the varicella vaccine

Placebo

PLACEBO COMPARATOR

Placebo with no live virus

Biological: one shot of placebo

Interventions

One shot of the zoster vaccine BIOLOGICAL

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

Zoster vaccine, Live

One shot of the varicella vaccine BIOLOGICAL

One shot of the varicella vaccine (with live virus \>=3.3 LgPFU per dose)

Varicella vaccine, Live

one shot of placebo BIOLOGICAL

one shot of placebo with no live virus

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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.
• Patients with chronic diseases need to be in a stable period.
• 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 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Zhaoge, Henan, 450016, 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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: November 20, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)