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The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after a mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such several countries including United States, Israel and Chile have recommended a third vaccine dose for this vulnerable population.
In this observational study we will explore the humoral response to the BNT162b2 vaccine in patients who received two previous doses of the inactivated vaccine Coronavac or two doses of BNT162b2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three doses of BNT162b2. | Cancer patients on active cytotoxic treatment who received three doses of BNT162b2. |
| |
| Two doses of Coronavac and one of BNT162b2. | Cancer patients on active cytotoxic treatment who received two doses of Coronavac and one dose of BNT162b2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three doses of BNT162b2 (observational) | Biological | BNT162b2 (COVID 19 mRNA vaccine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine). | 8 to12 weeks after third dose BNT162b2. |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine) | 8 to12 weeks after third dose BNT162b2. |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients receiving their care at the Red de Salud UC Christus in Santiago Chile will be invited
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Nervi | Contact | 9978073559 | bnervi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red de Salud UC Christus | Recruiting | Santiago | Chile |
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| Two doses of Coronavac and one dose BNT162b2 (observational) | Biological | BNT162b2 (COVID 19 mRNA vaccine) Coronavac (COVID 19 inactive vaccine) |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| C000722216 | sinovac COVID-19 vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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