Correlation of Protection Against Varicella in an Exploratory Study

NCT06482216 | Not Yet Recruiting

• 1 other identifier: PRO-VZV-4007
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.

Conditions

Varicella

Outcome Measures

Primary Outcomes (4)

• Retrospective cohort: Varicella confirmed case

  Varicella confirmed case during an additional year follow-up period (pooled with varicella confirmed case from previous phase Ⅲ study)

  one year after enrollment

• Retrospective cohort: Varicella antibody titer

  Varicella antibody titer on Day 30 after vaccination (historical serum)

  on Day 30 after vaccination

• Prospective cohort: Varicella confirmed case

  Varicella confirmed case during the 14-day follow-up period

  Within 14 days after enrollment

• Prospective cohort: Varicella antibody titer

  Varicella antibody titer on exposure

  Enrollment

Secondary Outcomes (2)

• Prospective cohort: Varicella antibody titer

  Within 3 days after eruption

• Prospective cohort: Varicella antibody titer

  Within 14-21 days after eruption

Study Arms (2)

Vaccination group

The last dose of varicella vaccine given 30 days before enrollment was manufacture by Sinovac (Dalian) Vaccine Technology Co. LTD.,(Sinovac).

Biological: Varicella vaccine

Non-vaccination group

Without varicella vaccine history

Interventions

Varicella vaccine BIOLOGICAL

lyophilized powder,subcutaneous injection

Vaccination group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

There was no inclusion/exclusion criteria in the retrospective cohort study. The inclusion/exclusion criteria were only applicable in the prospective cohort. Subjects in the retrospective cohort study aged 8-20 years were from a previous phase Ⅲ study. There is no limit to the sample size of the retrospective cohort, which is based on the number of final follow-up.

You may qualify if:

• years children who were the siblings or children of the indicator varicella cases, or the deskmates/roommates of the indicator varicella cases;
• Having close contacts with the indicator varicella cases at least 2 days during the period from 5 days before the onset and 2 days after the onset;
• Without varicella vaccination history or having varicella vaccination history (the last dose of varicella was manufacured by Sinovac, with an interval of \>30 days before enrollment)
• Subjects/legal guardian can understand and sign the informed consent;
• Being able to provide legal proof of identity.

You may not qualify if:

• Without varicella history;
• Body temperature ≥37.0℃ on the day of enrollment, or skin rash on the head, torso, and limbs;
• Having any confirmed or suspected immunodeficiency disorder, including tumor patients undergoing chemotherapy, human immunodeficiency virus (HIV) infection, continuous use of steroid hormones for more than 30 days (prednisone equivalent ≥2mg/kg days in children), or having other immunosuppressive disorder as determined by the clinician;
• The investigators considered that participation in this study was not appropriate for various other reasons.

Sponsors & Collaborators

• Sinovac (Dalian) Vaccine Technology Co., Ltd.: lead

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Xiaoqiang Liu

  Yunnan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Zhiqiang Xie

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqiang Liu

CONTACT

15911568282; lxq7611@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: October 10, 2025
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): October 10, 2028
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share