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

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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Key information

Conditions

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

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inactive SARS-Cov-2 vaccine

Biological

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

Primary outcomes

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.
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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 22, 2022
Registry last updated: Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed