Correlation of Protection Against Varicella in an Exploratory Study

Sinovac

Status

Begins enrollment in 2 months

Conditions

Varicella

Treatments

Biological: Varicella vaccine

Study type

Observational

Funder types

Industry

Identifiers

NCT06482216

PRO-VZV-4007

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

1 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.