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

April 16, 2022 updated by: Liu Yonghong, Xijing Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We retrospectively enrolled epilepsy patients visiting outpatient clinics of the above two centers from July 2021 to December 2021, who took inactivated vaccines from Sinovac Life Sciences and Sinopharm Group (China). The study included both adults and children aged above 3 years. All the patients were diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) Commission 90 days before till 21 days after the first dose of vaccine. Demographics, clinical manifestations and vaccination records were collected.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients
Time Frame: 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.
from 90 days before until 21 days after the first dose of vaccine
Risk of epileptic seizures in epilepsy patients of different subgroups
Time Frame: 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
from 90 days before until 21 days after the first dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

April 16, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 16, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20222046-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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