A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People

The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.

Study Overview

• Status: Active, not recruiting
• Conditions: Varicella
• Intervention / Treatment: Biological: Investigational live attenuated varicella vaccine; Biological: Placebo of live attenuated varicella vaccine

Detailed Description

This trial is aim to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children aged 1-12 years old.

This study will be conducted in two stage. the stage 1 adopts an open design, and 20 subjects aged 18~59 and 13~17 years old (18~59 years old→ 13~17 years old, sequentially enrolled) are enrolled, and 1 dose of the trial vaccine is administered to explore safety.

The stage 2 adopts a randomized, blinded, placebo-controlled design, 12400 healthy participants aged 1-12 years old will be randomly assigned into experimental group or control group with the ratio 1:1.

• Study Type: Interventional
• Enrollment (Actual): 12440
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yunkai Yang; Phone Number: +8613601126881; Email: yangyunkai@sinopharm.com

Study Locations

• China
  • Guizhou
    • Tongren, Guizhou, China
      • Songtao Miao Autonomous County Center for Disease Control and Prevention
    • Tongren, Guizhou, China
      • Sinan County Center for Disease Control and Prevention
    • Tongren, Guizhou, China
      • Yuping Dong Autonomous County Center for Disease Control and Prevention
  • Henan
    • Hebi, Henan, China
      • Qi County Center for Disease Control and Prevention
    • Jiaozuo, Henan, China
      • Wuzhi County Center for Disease Control and Prevention
    • Luohe, Henan, China
      • Wuyang County Center for Disease Control and Prevention
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221600
      • Pei County Center for Disease Control and Prevention
      • Contact: Xianzhang Huang; Phone Number: +8615262119606
    • Xuzhou, Jiangsu, China, 223300
      • Huaiyin District Center for Disease Control and Prevention
  • Sichuan
    • Mianyang, Sichuan, China
      • Mianyang Anzhou District Center for Disease Control and Prevention
    • Nanchong, Sichuan, China
      • Southern County Center for Disease Control and Prevention
    • Neijiang, Sichuan, China
      • Neijiang City Center for Disease Control and Prevention
  • Yunnan
    • Pu'er, Yunnan, China
      • Lancang Lahu Autonomous County Center for Disease Control and Prevention
    • Wenshan, Yunnan, China
      • Yanshan County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 59 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteer between 13 - 59 years old for Stage 1, 1-12 years old for Stage 2, and be able to provide legal identification ;
• Subject and/or guardian has the ability to understand study requirements and processes, consent to participate in clinical trials, and sign informed consent forms;
• Consent to use effective contraception during study participation, no pregnancy and no family planning (for women of childbearing potential or their spouses);
• Axillary temperature ≤ 37.0 °C on the day of enrollment;

Exclusion Criteria:

• Has received any varicella vaccine before ( Not applicable to Stage 1）;
• Has history of varicella or herpes zoster infection, or contact with varicella/shingles patients or suspected varicella/shingles patients within 30 days before enrollment ( Not applicable to Stage 1）;
• Currently using salicylates (including salicylic acid, aspirin, diflunisalin, p-aminosalicylate (sodium), dicalicylate, benoxate, etc.), or plan to use it for a long time during the study；
• Have had febrile illness (axillary temperature ≥ 38.5 °C) or used antipyretic, analgesic, anti-allergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination；
• Have a history of allergy to vaccine components and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, local allergic necrosis (Arthus) reaction, severe urticaria, etc；
• Have a history of epilepsy, convulsions or convulsions, and have a family history of severe neurological disease or psychosis
• Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases；
• With severe congenital malformations, hereditary diseases, serious cardiovascular diseases, serious liver/kidney diseases, complicated diabetes, malignant tumors, and severe malnutrition
• Immunosuppressant therapy, such as long-term oral or injectable glucocorticoid therapy (≥ 14 days, dose ≥2 mg/kg/day or ≥20 mg/day or equivalent to prednisone), within 3 months prior to enrollment or planned within 30 days of vaccination, but topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are not restricted
• Have received blood/blood-related products or immunoglobulins 3 months prior to vaccination, or plan to use such products 30 days after vaccination；
• Have received a live attenuated vaccine within 30 days prior to the trial vaccine, or any vaccine within 14 days prior to vaccination;
• Asplenectomy or splenectomy due to any condition (e.g. splenectomy);
• Those with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection;
• Suffering from various infectious, purulent or allergic skin diseases;
• Are participating in other investigational or unregistered clinical trials of products (drugs, vaccines or devices, etc.), or have plans to participate in other clinical trials before the end of this clinical trial;
• Has any other factors that are not suitable for participation in the clinical trial in the judgment of the investigator

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Single subcutaneous injection of the investigational vaccine (0.5 ml)	Biological: Investigational live attenuated varicella vaccine; 0.5 ml/vial
Placebo Comparator: Placebo Group; Single subcutaneous injection of the investigational placebo (0.5 ml)	Biological: Placebo of live attenuated varicella vaccine; 0.5 ml/vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidences of varicella in each group	The first 24 cases of varicella occurred 30 days after injection will be collected	number of cases reported 30 days after vaccination
The efficacy of the live attenuated varicella vaccine	The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination	number of cases reported 30 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidences of adverse events (AEs)	AEs occurred within 30 days after injection will be collected	within 30 days after vaccination
The incidences of serious adverse events (SAEs)	SAEs occurred within 6 months after vaccination will be collected	at least 6 months after vaccination
The geometric mean titer (GMT) in the immunogenicity subgroup	Geometric mean titer (GMT) will be measured before and 30 days after vaccination	30 days after vaccination
The seroconversion rate of the immunogenicity subgroup	The seroconversion rate will be calculated before and 30 days after vaccination	30 days after vaccination
The geometric mean fold increase (GMI) of the immunogenicity subgroup	Geometric mean fold increase (GMI) of the immunogenicity group will be calculated based on the geometric mean titer	30 days after vaccination
The immune persistence of the immunogenicity subgroup	Geometric mean titer (GMT) will be measured	1 year, 2 years, and 3 years after vaccination
The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella	The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination	number of cases reported 30 days after vaccination
The vaccine efficacy against clinical-confirmed cases	calculated based on the reported cases occurred 30 days after vaccination	number of cases reported 30 days after vaccination

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.; Jiangsu Province Center for Disease Control and Prevention
• Investigators: Principal Investigator: Hongxing Pan, Jiangsu Province Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2022
• Primary Completion (Estimated): April 14, 2024
• Study Completion (Estimated): September 14, 2026

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: safety; immunogenicity; vaccine efficacy; varicella vaccine
• 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: CNBG-BIBP-VZV-07

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