Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2

• Conditions: COVID-19

• Registration Number: NCT05153850
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

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.

Detailed Description

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.

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-10
• Last Update Submitted: 2021-12-13
• Study Start: 2022-01-01
• Last Update Posted: 2022-01-03
• Primary Completion: 2022-06-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 243

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

• Last vaccination dose more than four months ago from the determination of antibodies against SARS-Cov2.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with peripheral blood antibodies against SARS-COV2.	Up to 16 weeks.	Seroconversion rate against SARS-COV2 defined as the presence of antibodies in peripheral blood four months after the complete vaccination schedule against SARS-COV2.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Andalucía, Spain