Clinical trial NCT06482216: Correlation of Protection Against Varicella in an Exploratory Study
Official title: Correlation of Protection Against Varicella in an Exploratory Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Varicella
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Part 1 was based on a previous Phase Ⅲ, randomized, placebo-controlled clinical trial (NCT02981836) conducted from 2016 to 2017. The analysis data of part 1 was from historical serum, historical varicella cases and additional one year case monitoring conducted as an extension of the Phase III study.

Part 2 was conducted based on close contacts of varicella cases. All close contacts without varicella symptoms will be recruited and followed up for 14 days to monitor the occurrence of the varicella cases. Part 2 aimed to compare the differences of FAMA antibody titers in varicella breakthrough cases, non-breakthrough cases, and non-cases at the time of exposure to validate/calibrate the model established in part 1.

Eligibility criteria: Inclusion Criteria:

* 1-12 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Retrospective cohort: Varicella confirmed case
timeFrame: one year after enrollment
measure: Retrospective cohort: Varicella antibody titer
timeFrame: on Day 30 after vaccination
measure: Prospective cohort: Varicella confirmed case
timeFrame: Within 14 days after enrollment
measure: Prospective cohort: Varicella antibody titer
timeFrame: Enrollment
Secondary outcomes:
measure: Prospective cohort: Varicella antibody titer
timeFrame: Within 3 days after eruption
measure: Prospective cohort: Varicella antibody titer
timeFrame: Within 14-21 days after eruption
Other outcomes:
Locations:
Study officials:
affiliation: Yunnan Provincial Center for Disease Control and Prevention
name: Xiaoqiang Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial Center for Disease Control and Prevention
name: Zhiqiang Xie
role: PRINCIPAL_INVESTIGATOR
References: