Clinical trial NCT04888793: Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
Official title: Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
COVID-19 Vaccines
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving care at the Red de Salud UC Christus in Santiago, Chile will be invited.

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.


Eligibility 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

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.

Primary outcomes:
measure: Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine
timeFrame: 8 to12 weeks after Coronavac vaccine
Secondary outcomes:
measure: Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine
timeFrame: 8 to12 weeks after Coronavac vaccine
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Red de Salud UC Christus
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Elvira Balcells, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.