NCT05341713

Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination

Epileptic Seizure in Epilepsy Patients After First-dose Inactivated SARS-CoV-2 Vaccination: a Self-controlled Case Series Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study. Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.

Conditions

• Epileptic Seizures Related to Drugs
• SARS-CoV-2 Acute Respiratory Disease
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	inactive SARS-Cov-2 vaccine	We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2022-04-22
• Last updated: 2022-04-22

Locations

1 site across 1 country: China