Completed

NCT Number: NCT04888793

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

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.

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Key information

Conditions

Covid19 COVID-19 COVID-19 Vaccines Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Red de Salud UC Christus

Santiago, Chile

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serologic immune response evaluation

Diagnostic Test

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

Primary outcomes

Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine

Time frame: 8 to12 weeks after Coronavac vaccine

Secondary outcomes

Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine

Time frame: 8 to12 weeks after Coronavac vaccine

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: May 17, 2021
Registry last updated: Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed