Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old

A Randomized, Blind, Controlled Clinical Trial to Evaluate Safety and Immunogenicity of Live Attenuated Varicella Vaccine After a Two-dose Vaccination Course in Healthy Population Aged ≥13 Years Old

This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.

Study Overview

• Status: Completed
• Conditions: Varicella
• Intervention / Treatment: Biological: Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.; Biological: Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd

Detailed Description

This study is a randomized, blind, controlled phase III clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Shanghai Institute of Biological Products Co.,Ltd.. A total of 2480 subjects aged 13 years and older will be enrolled with 1240 subjects in 13~17 years old group and1240 subjects in 18 years and older group. 1240 subjects in each age group would be randomly divided into experimental group and control group according to 1:1 ratio, and subjects will receive two doses of vaccine with the immunization course of 0,28 days or 0,56 days. In addition, 400 subjects from experimental group (100 subjects per subgroup) would be selected to collect blood at 3 and 5 years after immunization to evaluate immune persistence of live attenuated varicella vaccines.

• Study Type: Interventional
• Enrollment (Actual): 2480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dandan Chen; Phone Number: 86-021-62750096; Email: chendandan3@sinopharm.com
• Study Contact Backup: Name: Cheng Fu; Phone Number: 86-021-62800991; Email: fucheng@sinopharm.com

Study Locations

• China
  • Henan
    • Zhenzhou, Henan, China
      • Henan Provincial Center for Disease Prevention and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy population aged 13 years and above;
• Proven legal identity;
• The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form).

Exclusion Criteria:

• Disease history or vaccine history of chickenpox or shingles;
• Have fever before vaccination, axillary temperature >37.0°C;
• Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
• History of severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
• Autoimmune disease or immunodeficiency / immunosuppression;
• Severe chronic diseases, severe cardiovascular diseases, hypertension (adult field measurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg) that could not be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
• Family history of psychosis,severe neurological disease (epilepsy, convulsions or twitching) or mental illness;
• Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
• History of alcohol or drug abuse;
• Receipt of blood products within in the past 6 months;
• Participating in other drug/vaccine clinical trial;
• Receipt of attenuated live vaccines in the past 28 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;
• Onset of various acute or chronic diseases within 7 days prior to the study;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group with the immunization course of 0,28 days or 0,56 days; 1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days.	Biological: Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.; live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection
Active Comparator: Control Group; 1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days.	Biological: Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd; live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate of HI antibody	The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.	Day 42 after the whole schedule
GMT of HI antibody	The GMT of the antibody 42 days among all subjects after the second vaccination.	Day 42 after the whole schedule

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection rate of HI antibody	The seroprotection rate of the antibody 42 days among all subjects after the second vaccination.	Day 42 after the whole schedule
Incidence of adverse reactions within 30 minutes after each dose	Incidence of adverse reactions within 30 minutes after each dose vaccination with immunization course of 0,28 days and 0,56 days.	Within 30 minutes after each dose
Incidence of adverse reactions within 0~28 days after each dose	Incidence of adverse reactions within 0~28 days after each dose vaccination with immunization course of 0,28 days and 0,56 days.	Within 0~28 days after each dose
Incidence of serious adverse events	Incidence of serious adverse events from vaccination to 6 months after the second vaccination with immunization course of 0,28 days and 0,56 days	From vaccination to 6 months after the second vaccination

Collaborators and Investigators

• Sponsor: Shanghai Institute Of Biological Products
• Investigators: Principal Investigator: Yanxia Wang, Henan Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2022
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 24, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2020LP00094-III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No