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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04888793
Other study ID # 210405014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2021
Est. completion date November 1, 2021

Study information

Verified date May 2021
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date November 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2

Locations

Country Name City State
Chile Red de Salud UC Christus Santiago

Sponsors (1)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine 8 to12 weeks after Coronavac vaccine
Secondary Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine 8 to12 weeks after Coronavac vaccine
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