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This is a Phase II study designed to investigate if the Covid 19 vaccines are capable of eliciting production of antibodies against S protein of Sar-S-Cov-2 virus among patients with medical history of cancer previously treated with monoclonal anti CD-20 antibodies. The antibody production is defined based on the detection of antibodies in the serologic Covid-19 rapid test against S protein or with semiquantitative assay when it becomes available.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Samples | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | To determine if patients with cancer history or HIV positivity previously treated with monoclonal anti CD-20 are able to produce antibodies after Covid-19 vaccination. a. Antibody Production defined as: 1. Positive serologic Covid-19 antibodies rapid test against S protein. | Two weeks after full dose vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objective 1 | Evaluate the Correlation of immunoglobulin levels and the development of Covid-19 antibodies. | Two weeks after full dose vaccination. |
| Secondary objective 2 | Evaluate the correlation of CD4/CD8 counts with the development of Covid-19 antibodies. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients either diagnosed with cancer or with HIV positivity or treated with an antineoplastic regimen including anti CD-20 after Covid-19 vaccine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Cabanillas, MD | Contact | 787-758-2000 | 3503 | cabanillasmd@gmail.com |
| Carmen Morales | Contact | 787-758-2000 | 3503 | camorales@auxiliomutuo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auxilio Mutuo Cancer Center | Recruiting | San Juan | 00918 | Puerto Rico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32671831 | Background | Baker D, Roberts CAK, Pryce G, Kang AS, Marta M, Reyes S, Schmierer K, Giovannoni G, Amor S. COVID-19 vaccine-readiness for anti-CD20-depleting therapy in autoimmune diseases. Clin Exp Immunol. 2020 Nov;202(2):149-161. doi: 10.1111/cei.13495. Epub 2020 Aug 1. | |
| 32619884 | Background | Houot R, Levy R, Cartron G, Armand P. Could anti-CD20 therapy jeopardise the efficacy of a SARS-CoV-2 vaccine? Eur J Cancer. 2020 Sep;136:4-6. doi: 10.1016/j.ejca.2020.06.017. Epub 2020 Jun 25. |
| Label | URL |
|---|---|
| OpenSAFELY: factors associated with COVID-19-related hospital death in the linked electronic health records of 17 million adult NHS patients. | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009369 | Neoplasms |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Two weeks after full dose vaccination. |
| 9704735 | Background | McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |