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

Sponsor

Xijing Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05341713

Collaborator

(none)

240

Enrollment

Location

Actual Duration (Months)

81.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Epileptic Seizures Related to Drugs SARS-CoV-2 Acute Respiratory Disease Vaccine Adverse Reaction	Biological: inactive SARS-Cov-2 vaccine

Study Design

Study Type:

Observational

Actual Enrollment :

240 participants

Observational Model:

Case-Crossover

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Apr 1, 2022

Actual Study Completion Date :

Apr 1, 2022

Outcome Measures

Primary Outcome Measures

Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients [from 90 days before until 21 days after the first dose of vaccine]
Overall relative incidence of epileptic seizures in risk periods compared to control period.
Risk of epileptic seizures in epilepsy patients of different subgroups [from 90 days before until 21 days after the first dose of vaccine]
The associations of sex, age or medication status with the relative incidence in risk periods

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital	Xi'an	Shaanxi	China	710000

Sponsors and Collaborators

Xijing Hospital

Investigators

Principal Investigator: Gengyao Hu, doctor, Air Force Military Medical University, China
Principal Investigator: Ze Chen, master, Air Force Military Medical University, China
Principal Investigator: Kejian Wu, doctor, Air Force Military Medical University, China
Principal Investigator: Yuanhang Pan, master, Air Force Military Medical University, China
Principal Investigator: Xia Li, master, Xian Children's Hospital
Study Director: Junxiang Bao, doctor, Air Force Military Medical University, China
Study Chair: Yonghong Liu, doctor, Air Force Military Medical University, China