Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 (COVID-19)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown

Conditions

COVID-19

Study type

Observational

Funder types

Other

Identifiers

NCT05153850

FIS-COV-2021-01

Details and patient eligibility

About

Prospective observational single-center study in which the impact of anti-TNF biological treatment on the humoral response after complete vaccination against SARS-COV2 in patients with inflammatory bowel disease is analyzed.

Full description

The first objective is to compare the seroconversion rate after full vaccination against SARS-COV2 in patients with IBD treated with anti-TNF drugs versus patients treated with Ustekinumab / Vedolizumab and patients without immunosuppressive treatment.

The Patients included in the study belong to the health area of the Virgen Macarena University Hospital who meet the following inclusion criteria and none for exclusion.

Enrollment

243 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be of legal age (> 18 years).
Diagnosis of inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis).
Complete vaccination schedule (one or two doses depending on previous SARS-Cov2 infection) between one and four months prior to the determination of anti-SARS-Cov2 antibodies.
Treatment with biological therapy for at least 6 weeks prior to the time of vaccination for the group of patients treated with biological drugs.

Exclusion criteria