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

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Completed
CT.gov ID
NCT04888793
Collaborator
(none)
260
Enrollment
1
Location
5.7
Actual Duration (Months)
45.7
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Serologic immune response evaluation

Study Design

Study Type:
Observational
Actual Enrollment :
260 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
Actual Study Start Date :
May 12, 2021
Actual Primary Completion Date :
Sep 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

ArmIntervention/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

  1. Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine [8 to12 weeks after Coronavac vaccine]

Secondary Outcome Measures

  1. Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine [8 to12 weeks after Coronavac vaccine]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Red de Salud UC ChristusSantiagoChile

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.
Responsible Party:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT04888793
Other Study ID Numbers:
  • 210405014
First Posted:
May 17, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021