Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Cancer Patients on active treatment
|
Diagnostic Test: Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2
|
Bone marrow transplant patients
|
Diagnostic Test: Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2
|
Solid organ transplant recipients
|
Diagnostic Test: Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2
|
HIV patients
|
Diagnostic Test: Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2
|
Rheumatic disease patients
|
Diagnostic Test: Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2
|
Healthy controls
|
Diagnostic Test: Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2
|
Outcome Measures
Primary Outcome Measures
- Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine [8 to12 weeks after Coronavac vaccine]
Secondary Outcome Measures
- Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine [8 to12 weeks after Coronavac vaccine]
Eligibility Criteria
Criteria
General Inclusion Criteria:
-
Eastern Cooperative Oncology Group < 3
-
Vaccination with 2 doses of Coronavac vaccine
General Exclusion Criteria:
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Previous SARS-CoV-2 infection
-
Vaccination with Coronavac more than 12 weeks before informed consent
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Intravenous immunoglobulin therapy 60 days before informed consent
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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
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Red de Salud UC Christus | Santiago | Chile |
Sponsors and Collaborators
- Pontificia Universidad Catolica de Chile
Investigators
- Principal Investigator: Elvira Balcells, MD, Pontificia Universidad Catolica de Chile
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 210405014