Clinical trial NCT05341713: Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination
Official title: Epileptic Seizure in Epilepsy Patients After First-dose Inactivated SARS-CoV-2 Vaccination: a Self-controlled Case Series Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epileptic Seizures Related to Drugs
SARS-CoV-2 Acute Respiratory Disease
Vaccine Adverse Reaction
Keywords: epilepsy patient
risk of seizure
SARS-Cov-2 vaccine
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients
timeFrame: from 90 days before until 21 days after the first dose of vaccine
measure: Risk of epileptic seizures in epilepsy patients of different subgroups
timeFrame: from 90 days before until 21 days after the first dose of vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Gengyao Hu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Ze Chen, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Kejian Wu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Yuanhang Pan, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Xian Children's Hospital
name: Xia Li, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Junxiang Bao, doctor
role: STUDY_DIRECTOR
affiliation: Air Force Military Medical University, China
name: Yonghong Liu, doctor
role: STUDY_CHAIR
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