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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer Patients on active treatment |
| ||
| Bone marrow transplant patients |
| ||
| Solid organ transplant recipients |
| ||
| HIV patients |
| ||
| Rheumatic disease patients |
| ||
| Healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serologic immune response evaluation | Diagnostic Test | Detection of total and neutralizing antibodies against SARS-CoV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine | 8 to12 weeks after Coronavac vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine | 8 to12 weeks after Coronavac vaccine |
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General Inclusion Criteria:
General Exclusion Criteria:
Cancer Cohort
Inclusion Criteria:
Exclusion Criteria:
Bone Marrow Transplant Cohort
Inclusion Criteria:
Exclusion Criteria:
Solid Organ Recipient Cohort:
Inclusion Criteria:
Exclusion Criteria:
- Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV
HIV Cohort:
Inclusion Criteria:
Exclusion Criteria:
Rheumatic Disease Cohort
Inclusion Criteria:
Exclusion Criteria:
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Patients receiving care at the Red de Salud UC Christus in Santiago, Chile will be invited.
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| Name | Affiliation | Role |
|---|---|---|
| Elvira Balcells, MD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red de Salud UC Christus | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35255140 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |