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

Vaccine Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341713
• Other study ID #: KY20222046-C-1
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Epilepsy
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease
• Seizures
• Vaccine Adverse Reaction

Intervention

Biological:
• inactive SARS-Cov-2 vaccine
We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Arnheim-Dahlström L, Hällgren J, Weibull CE, Sparén 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. — View Citation

Cabezudo-García P, Ciano-Petersen NL, Mena-Vázquez N, Pons-Pons G, Castro-Sánchez 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. — View Citation

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. — View Citation

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. doi: 10.1002/ana.26339. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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