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

NCT05341713 | Completed

• 1 other identifier: KY20222046-C-1
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients

  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

  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

Interventions

inactive SARS-Cov-2 vaccine BIOLOGICAL

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

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710000, China

Location

Related Publications (5)

• Frontera JA, Sabadia S, Lalchan R, Fang T, Flusty B, Millar-Vernetti P, Snyder T, Berger S, Yang D, Granger A, Morgan N, Patel P, Gutman J, Melmed K, Agarwal S, Bokhari M, Andino A, Valdes E, Omari M, Kvernland A, Lillemoe K, Chou SH, McNett M, Helbok R, Mainali S, Fink EL, Robertson C, Schober M, Suarez JI, Ziai W, Menon D, Friedman D, Friedman D, Holmes M, Huang J, Thawani S, Howard J, Abou-Fayssal N, Krieger P, Lewis A, Lord AS, Zhou T, Kahn DE, Czeisler BM, Torres J, Yaghi S, Ishida K, Scher E, de Havenon A, Placantonakis D, Liu M, Wisniewski T, Troxel AB, Balcer L, Galetta S. A Prospective Study of Neurologic Disorders in Hospitalized Patients With COVID-19 in New York City. Neurology. 2021 Jan 26;96(4):e575-e586. doi: 10.1212/WNL.0000000000010979. Epub 2020 Oct 5.

  PMID: 33020166 BACKGROUND

• Cabezudo-Garcia P, Ciano-Petersen NL, Mena-Vazquez N, Pons-Pons G, Castro-Sanchez MV, Serrano-Castro PJ. Incidence and case fatality rate of COVID-19 in patients with active epilepsy. Neurology. 2020 Sep 8;95(10):e1417-e1425. doi: 10.1212/WNL.0000000000010033. Epub 2020 Jun 17.

  PMID: 32554773 BACKGROUND

• Frontera JA, Tamborska AA, Doheim MF, Garcia-Azorin D, Gezegen H, Guekht A, Yusof Khan AHK, Santacatterina M, Sejvar J, Thakur KT, Westenberg E, Winkler AS, Beghi E; contributors from the Global COVID-19 Neuro Research Coalition. Neurological Events Reported after COVID-19 Vaccines: An Analysis of VAERS. Ann Neurol. 2022 Mar 2;91(6):756-71. doi: 10.1002/ana.26339. Online ahead of print.

  PMID: 35233819 BACKGROUND

• Massoud F, Ahmad SF, Hassan AM, Alexander KJ, Al-Hashel J, Arabi M. Safety and tolerability of the novel 2019 coronavirus disease (COVID-19) vaccines among people with epilepsy (PwE): A cross-sectional study. Seizure. 2021 Nov;92:2-9. doi: 10.1016/j.seizure.2021.08.001. Epub 2021 Aug 6.

  PMID: 34391030 BACKGROUND

• Arnheim-Dahlstrom L, Hallgren J, Weibull CE, Sparen P. Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study. BMJ. 2012 Dec 18;345:e7594. doi: 10.1136/bmj.e7594.

  PMID: 23274350 BACKGROUND

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Junxiang Bao, doctor

  Air Force Military Medical University, China

  STUDY DIRECTOR

• Yonghong Liu, doctor

  Air Force Military Medical University, China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: January 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

CN (1)