Correlation of Protection Against Varicella in an Exploratory Study
ConditionVaricella
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorSinovac (Dalian) Vaccine Technology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Varicella vaccine
Biological/Vaccinelyophilized powder,subcutaneous injection
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Vaccination group1 intervention
Group B: Non-vaccination group0 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
one year after enrollment2
Retrospective cohort: Varicella antibody titer
Varicella antibody titer on Day 30 after vaccination (historical serum)
Time frame
on Day 30 after vaccination3
Prospective cohort: Varicella confirmed case
Varicella confirmed case during the 14-day follow-up period
Time frame
Within 14 days after enrollment4
Prospective cohort: Varicella antibody titer
Varicella antibody titer on exposure
Time frame
EnrollmentSecondary outcomes
1
Prospective cohort: Varicella antibody titer
Varicella antibody titer in the acute period of varicella confirmed case
Time frame
Within 3 days after eruption2
Prospective cohort: Varicella antibody titer
Varicella antibody titer in the convalescent period of varicella confirmed case
Time frame
Within 14-21 days after eruptionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: