Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Pontificia Universidad Catolica de Chile
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eastern Cooperative Oncology Group \< 3
- •Vaccination with 2 doses of Coronavac vaccine
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.
Outcomes
Primary Outcomes
Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine
Time Frame: 8 to12 weeks after Coronavac vaccine
Secondary Outcomes
- Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine(8 to12 weeks after Coronavac vaccine)