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

NCT ID: NCT04888793

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-12

Study Completion Date

2021-11-01

Brief Summary

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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

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Conditions

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Covid19 COVID-19 Vaccines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer Patients on active treatment

Serologic immune response evaluation

Intervention Type DIAGNOSTIC_TEST

Detection of total and neutralizing antibodies against SARS-CoV-2

Bone marrow transplant patients

Serologic immune response evaluation

Intervention Type DIAGNOSTIC_TEST

Detection of total and neutralizing antibodies against SARS-CoV-2

Solid organ transplant recipients

Serologic immune response evaluation

Intervention Type DIAGNOSTIC_TEST

Detection of total and neutralizing antibodies against SARS-CoV-2

HIV patients

Serologic immune response evaluation

Intervention Type DIAGNOSTIC_TEST

Detection of total and neutralizing antibodies against SARS-CoV-2

Rheumatic disease patients

Serologic immune response evaluation

Intervention Type DIAGNOSTIC_TEST

Detection of total and neutralizing antibodies against SARS-CoV-2

Healthy controls

Serologic immune response evaluation

Intervention Type DIAGNOSTIC_TEST

Detection of total and neutralizing antibodies against SARS-CoV-2

Interventions

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Serologic immune response evaluation

Detection of total and neutralizing antibodies against SARS-CoV-2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group \< 3
* Vaccination with 2 doses of Coronavac vaccine


* Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
* Life expectancy more than 12 weeks


* Bone marrow transplant between January 2019 and December 2020


* Liver, kidney or heart transplant between January 2019 and December 2020
* Active immunosuppressant treatment


* CD4 \<= 500 cels/mm3 documented one year before study enrollment
* Active antiretroviral therapy
* Viral load \< 200 copies/ml


* 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

* 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


* Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for other condition.

Bone Marrow Transplant Cohort


* Other cancer diagnosis during the last 5 years, solid organ recipient, HIV, immunosuppressant treatment for other condition.

Solid Organ Recipient Cohort:


\- Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV

HIV Cohort:


* Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, immunosuppressant treatment.

Rheumatic Disease Cohort


* Treatment with more than one biological agent.
* Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, HIV diagnosis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elvira Balcells, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

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Red de Salud UC Christus

Santiago, , Chile

Site Status

Countries

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Chile

References

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Balcells ME, Le Corre N, Duran J, Ceballos ME, Vizcaya C, Mondaca S, Dib M, Rabagliati R, Sarmiento M, Burgos PI, Espinoza M, Ferres M, Martinez-Valdebenito C, Ruiz-Tagle C, Ortiz C, Ross P, Budnik S, Solari S, Vizcaya MLA, Lembach H, Berrios-Rojas R, Melo-Gonzalez F, Rios M, Kalergis AM, Bueno SM, Nervi B. Reduced Immune Response to Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Cohort of Immunocompromised Patients in Chile. Clin Infect Dis. 2022 Aug 24;75(1):e594-e602. doi: 10.1093/cid/ciac167.

Reference Type DERIVED
PMID: 35255140 (View on PubMed)

Other Identifiers

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210405014

Identifier Type: -

Identifier Source: org_study_id