Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study

Pontificia Universidad Catolica de Chile

Status

Completed

Conditions

COVID-19 Vaccines

Covid19

Treatments

Diagnostic Test: Serologic immune response evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT04888793

210405014

Details and patient eligibility

About

Despite COVID-19 pandemic having started more than one year ago, there are still limited treatment options for these patients, and over 145 million cases and 3 millions deaths have ensued worldwide. Fortunately, SARSCoV2 vaccines have been developed at an unprecedented pace. While the vaccination programs are still ongoing, early reports on efficacy are mainly centered on healthy population. In Chile most people have received the inactivated Coronavac vaccine. Data on the immune response after vaccination in immunocompromised patients is lacking. Therefore, this study aims to evaluate the immune response after Coronavac vaccine in 5 cohorts of immunocompromised patients and healthy controls. We will include patients with cancer, HIV, solid organ transplant and patients receiving immunomodulatory agents for rheumatic diseases.

Enrollment

260 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

Eastern Cooperative Oncology Group < 3
Vaccination with 2 doses of Coronavac vaccine

General Exclusion Criteria:

Previous SARS-CoV-2 infection
Vaccination with Coronavac more than 12 weeks before informed consent
Intravenous immunoglobulin therapy 60 days before informed consent
Any condition, that could interfere with the participant's participation during the study in the opinion of the treating investigator.

Cancer Cohort

Inclusion Criteria:

Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
Life expectancy more than 12 weeks

Exclusion Criteria:

Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for other condition.

Bone Marrow Transplant Cohort

Inclusion Criteria:

Bone marrow transplant between January 2019 and December 2020

Exclusion Criteria:

Other cancer diagnosis during the last 5 years, solid organ recipient, HIV, immunosuppressant treatment for other condition.

Solid Organ Recipient Cohort:

Inclusion Criteria:

Liver, kidney or heart transplant between January 2019 and December 2020
Active immunosuppressant treatment

Exclusion Criteria:

Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV

HIV Cohort:

Inclusion Criteria:

CD4 <= 500 cels/mm3 documented one year before study enrollment
Active antiretroviral therapy
Viral load < 200 copies/ml

Exclusion Criteria:

Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, immunosuppressant treatment.

Rheumatic Disease Cohort

Inclusion Criteria:

Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, relapsing polychondritis, Behcet disease or juvenile idiopathic arthritis
Chronic immunomodulatory treatment with anti-TNF, anti-IL6 or anti-IL17 agents

Exclusion Criteria:

Treatment with more than one biological agent.
Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, HIV diagnosis.