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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04888793

Enrollment

260

Registered

2021-05-17

Start date

2021-05-12

Completion date

2021-11-01

Last updated

2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, COVID-19 Vaccines

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.

Interventions

DIAGNOSTIC_TESTSerologic immune response evaluation

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine	8 to12 weeks after Coronavac vaccine

Secondary

Measure	Time frame
Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine	8 to12 weeks after Coronavac vaccine

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026