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

Completed

• Conditions: COVID-19 Vaccines; Covid19
• Interventions: Diagnostic Test: Serologic immune response evaluation

• Registration Number: NCT04888793
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-09
• Study Start: 2021-05-12
• Study First Posted: 2021-05-17
• Primary Completion: 2021-09-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatic disease patients	Serologic immune response evaluation	-
Solid organ transplant recipients	Serologic immune response evaluation	-
HIV patients	Serologic immune response evaluation	-
Cancer Patients on active treatment	Serologic immune response evaluation	-
Bone marrow transplant patients	Serologic immune response evaluation	-
Healthy controls	Serologic immune response evaluation	-

Primary Outcome Measures

Name	Time	Method
Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine	8 to12 weeks after Coronavac vaccine

Secondary Outcome Measures

Name	Time	Method
Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine	8 to12 weeks after Coronavac vaccine

Trial Locations

Locations (1)

Red de Salud UC Christus; 🇨🇱 Santiago, Chile