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

November 15, 2021 updated by: Pontificia Universidad Catolica de Chile
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Red de Salud UC Christus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving care at the Red de Salud UC Christus in Santiago, Chile will be invited.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Diagnostic test: Serologic immune response evaluation
Detection of total and neutralizing antibodies against SARS-CoV-2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine
Time Frame: 8 to12 weeks after Coronavac vaccine
8 to12 weeks after Coronavac vaccine

Secondary Outcome Measures

Outcome Measure
Time Frame
Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine
Time Frame: 8 to12 weeks after Coronavac vaccine
8 to12 weeks after Coronavac vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Elvira Balcells, MD, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 9, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210405014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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