Correlation of Protection Against Varicella in an Exploratory Study

PRO-VZV-4007

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.

2024-10-10

2025-10-10

2027-10-10

Not yet recruiting

400

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2024-07-01