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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Interventions

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inactive SARS-Cov-2 vaccine

We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female participants
* Have a diagnosis of epilepsy by the end of the study
* Have received at least one dose of inactive SARS-Cov-2 vaccine (Sinovac Life Sciences and Sinopharm Group)

Exclusion Criteria

* Non-epilepsy patients vaccinated with inactive SARS-Cov-2 vaccine
* Epilepsy patients administrated with non-inactive vaccine
* Unvaccinated epilepsy patients

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Liu Yonghong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR