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

NCT04888793 | Completed

• 1 other identifier: 210405014
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; COVID-19 Vaccines

Outcome Measures

Primary Outcomes (1)

• Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine

  8 to12 weeks after Coronavac vaccine

Secondary Outcomes (1)

• Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine

  8 to12 weeks after Coronavac vaccine

Study Arms (6)

Cancer Patients on active treatment

Diagnostic Test: Serologic immune response evaluation

Bone marrow transplant patients

Diagnostic Test: Serologic immune response evaluation

Solid organ transplant recipients

Diagnostic Test: Serologic immune response evaluation

HIV patients

Diagnostic Test: Serologic immune response evaluation

Rheumatic disease patients

Diagnostic Test: Serologic immune response evaluation

Healthy controls

Diagnostic Test: Serologic immune response evaluation

Interventions

Serologic immune response evaluation DIAGNOSTIC_TEST

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

Bone marrow transplant patients; Cancer Patients on active treatment; HIV patients; Healthy controls; Rheumatic disease patients; Solid organ transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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
• Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
• Life expectancy more than 12 weeks
• Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for other condition.
• Bone Marrow Transplant Cohort
• Bone marrow transplant between January 2019 and December 2020
• Other cancer diagnosis during the last 5 years, solid organ recipient, HIV, immunosuppressant treatment for other condition.
• Solid Organ Recipient Cohort:
• Liver, kidney or heart transplant between January 2019 and December 2020
• Active immunosuppressant treatment
• \- Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Red de Salud UC Christus

Santiago, Chile

Location

Related Publications (1)

• 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.

  PMID: 35255140 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elvira Balcells, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 17, 2021
• Study Start: May 12, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-05

Locations

CL (1)