A Phase III Clinical Trial Assessing the Immunogenicity and Safety of Lyophilized Live-Attenuated Varicella Vaccine in Healthy Subjects Aged 13 to 55 Years

NCT ID: NCT06592456

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-21
• Study Completion Date: 2021-11-08

Brief Summary

Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and adults Aged 13-55 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study

Conditions

Chickenpox Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Live Attenuated Varicella vaccine candidates

freezedried live attenuated VarV developed by Beijing Minhai Biotechnology Co., LTD., which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cells inoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers.

Group Type: EXPERIMENTAL

Chickenpox Vaccines

Intervention Type: BIOLOGICAL

The vaccines require reconstitution with the provided sterile water for injection nd should be shaken well before use. Each human dose (0.5 ml) contains at least 3.3 log PFU of VZV.

Marketed Live Attenuated Varicella vaccine

the active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers

Group Type: ACTIVE_COMPARATOR

Chickenpox Vaccines

Intervention Type: BIOLOGICAL

The vaccines require reconstitution with the provided sterile water for injection nd should be shaken well before use. Each human dose (0.5 ml) contains at least 3.3 log PFU of VZV.

Interventions

Chickenpox Vaccines

The vaccines require reconstitution with the provided sterile water for injection nd should be shaken well before use. Each human dose (0.5 ml) contains at least 3.3 log PFU of VZV.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy individuals aged between 13 to 55 years who are permanent residents; Have obtained informed consent from the volunteer and/or their legal guardian, and signed the informed consent form; The volunteer and/or their legal guardian can comply with the requirements of the clinical trial protocol; Axillary temperature ≤37.0°C.

Exclusion Criteria

• Females aged 18 to 55 years with a positive urine pregnancy test, pregnant women, women who are breastfeeding, or women planning to become pregnant within the next 3 months; Have a history of varicella vaccination, a history of chickenpox, or a history of herpes zoster infection; Allergic to known components of the study vaccine, or a history of severe allergic reactions to any vaccination; A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders; Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or having HIV-related immunocompromised status, or having close family members with congenital immune diseases; Have congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome); Known or suspected concurrent diseases including: respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors; Diagnosed with coagulation dysfunction (such as coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders; Have received blood products in the past 3 months; Have received live attenuated vaccines in the past 14 days or subunit or inactivated vaccines in the past 7 days; Have had various acute diseases or acute exacerbations of chronic diseases in the past 7 days; Have had a fever (axillary temperature ≥38.0°C) in the past 3 days; Any other factors deemed by the investigator as unsuitable for participation in the clinical trial.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Shiyuan Wang

Department of epidemiology and biostatistics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huaiyin District Center for Disease Control and prevention

Huaian, Jiangsu, China

Countries

China

References

Zhang Y, Wang S, Li G, Shi J, Chang X, Zhang H, Zhu F, Li J, Pan H, Sun J. Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase III clinical trial in China. Expert Rev Vaccines. 2025 Dec;24(1):157-164. doi: 10.1080/14760584.2025.2457463. Epub 2025 Feb 7.

Reference Type: DERIVED

PMID: 39916494 (View on PubMed)

Other Identifiers

JSVCT058

Identifier Type: -

Identifier Source: org_study_id