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

Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 in Patients With Inflammatory Bowel Disease Under Inmunosuppressor Treatment

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05153850

Acronym

COVID-19

Enrollment

243

Registered

2021-12-10

Start date

2022-01-01

Completion date

2022-09-01

Last updated

2022-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Contacts

Primary ContactFederico Argüelles Arias

farguelles@telefonica.net955 00 80 00

Backup ContactCarlos García Pérez

administracion.eecc.hvm.sspa@juntadeandalucia.es955 04 31 27

Outcome results