Correlation of Protection Against Varicella in an Exploratory Study

Launched by SINOVAC (DALIAN) VACCINE TECHNOLOGY CO., LTD. · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into how well the varicella (chickenpox) vaccine protects against the disease by measuring specific antibodies in the blood after vaccination. The study has two parts: the first part looks back at past data to see if higher levels of these antibodies can help predict whether someone might get chickenpox later on. The second part will confirm these findings with new participants. The goal is to find out what level of antibodies offers the best protection against chickenpox.

To be eligible for the study, children aged 1 to 12 who have been in close contact with someone who had chickenpox may be included. This means they could be siblings, roommates, or classmates of the person with chickenpox. It's important that these children either have not been vaccinated against chickenpox or received a specific vaccine at least 30 days before joining the study. Participants will need to provide consent and proof of identity. The study has not started recruiting participants yet, so there's no participation at this time, but it aims to gather important information about how effective the chickenpox vaccine can be.

Gender

ALL

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.