Cancer, Covid19, HIV Infections
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTLaboratory Samples
1. After full vaccination with a Covid 19 vaccine, the following laboratory samples will be taken one time only, two weeks after full dose vaccination: i. Serologic rapid test (IgG, IgM) ii. Serum quantitative immunoglobulin levels iii. CD4 level iv. CD8 level 2. Laboratory samples will be taken at Hospital Auxilio Mutuo Laboratorio Clínico. Likewise, the Immuno Reference Lab might be used as an alternative. 3. Since monoclonal antibody therapy can induce hypogammaglobulinemia, we will measure gammaglobulin levels to correlate with antibody response to vaccine. Similarly, we will evaluate the CD4 and CD8 counts.
Sponsors
Auxilio Mutuo Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients either diagnosed with cancer or with HIV positivity or treated with an antineoplastic regimen including anti CD-20 after Covid-19 vaccine will be registered on the study regardless of their type of cancer or type of antineoplastic regimen. * Patients 21 years or older diagnosed with cancer treated with antineoplastic regimen or anti CD-20, or with HIV infection vaccinated with 2 doses of anti Covid-19 vaccine. * Eligible patients will be registered on study after a Covid -19 vaccine has been scheduled. * In order to be screened for Covid 19 antibodies, they must be tested at least two weeks after the second dose of Covid-19 vaccination.
Exclusion criteria
* Anyone who has not been treated with anti-CD20 antibodies or with chemotherapy who doesn't have HIV infection or who has not received chemotherapy for cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | Two weeks after full dose vaccination. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary objective 1 | Two weeks after full dose vaccination. | Evaluate the Correlation of immunoglobulin levels and the development of Covid-19 antibodies. |
| Secondary objective 2 | Two weeks after full dose vaccination. | Evaluate the correlation of CD4/CD8 counts with the development of Covid-19 antibodies. |
Countries
Puerto Rico
Contacts
Primary ContactFernando Cabanillas, MD
Backup ContactCarmen Morales
Outcome results
None listed