Correlation of Protection Against Varicella in an Exploratory Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 400
- Primary Endpoint
- Retrospective cohort: Varicella antibody titer
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Vaccination group
The last dose of varicella vaccine given 30 days before enrollment was manufacture by Sinovac (Dalian) Vaccine Technology Co. LTD.,(Sinovac).
Intervention: Varicella vaccine (Biological)
Outcomes
Primary Outcomes
Retrospective cohort: Varicella antibody titer
Time Frame: on Day 30 after vaccination
Varicella antibody titer on Day 30 after vaccination (historical serum)
Retrospective cohort: Varicella confirmed case
Time Frame: one year after enrollment
Varicella confirmed case during an additional year follow-up period (pooled with varicella confirmed case from previous phase Ⅲ study)
Prospective cohort: Varicella antibody titer
Time Frame: Enrollment
Varicella antibody titer on exposure
Prospective cohort: Varicella confirmed case
Time Frame: Within 14 days after enrollment
Varicella confirmed case during the 14-day follow-up period
Secondary Outcomes
- Prospective cohort: Varicella antibody titer(Within 14-21 days after eruption)