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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19, COVID-19 Vaccines

Intervention / Treatment
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* Diagnostic Test: Serologic immune response evaluation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Patients on active treatment<br> | Diagnostic Test: Serologic immune response evaluation<br>* Detection of total and neutralizing antibodies against SARS-CoV-2<br>|
| Bone marrow transplant patients<br> | Diagnostic Test: Serologic immune response evaluation<br>* Detection of total and neutralizing antibodies against SARS-CoV-2<br>|
| Solid organ transplant recipients<br> | Diagnostic Test: Serologic immune response evaluation<br>* Detection of total and neutralizing antibodies against SARS-CoV-2<br>|
| HIV patients<br> | Diagnostic Test: Serologic immune response evaluation<br>* Detection of total and neutralizing antibodies against SARS-CoV-2<br>|
| Rheumatic disease patients<br> | Diagnostic Test: Serologic immune response evaluation<br>* Detection of total and neutralizing antibodies against SARS-CoV-2<br>|
| Healthy controls<br> | Diagnostic Test: Serologic immune response evaluation<br>* Detection of total and neutralizing antibodies against SARS-CoV-2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine |  | 8 to12 weeks after Coronavac vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine |  | 8 to12 weeks after Coronavac vaccine |