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NCT04779996 Clinical Trial

Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment

HIV Infections Clinical Trial

Official title:
Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04779996
Other study ID # CCAM 21-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 16, 2021
Est. completion date February 28, 2022

Study information
Verified date March 2021
Source Auxilio Mutuo Cancer Center
Contact Fernando Cabanillas, MD
Phone 787-758-2000
Email cabanillasmd@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date February 28, 2022
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Laboratory Samples
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 Laboratory samples will be taken at Hospital Auxilio Mutuo Laboratorio Clínico. Likewise, the Immuno Reference Lab might be used as an alternative. 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.

Locations
Country Name City State
Puerto Rico Auxilio Mutuo Cancer Center San Juan

Sponsors (1)
Lead Sponsor Collaborator
Auxilio Mutuo Cancer Center

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

McLaughlin P, Grillo-López 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
Secondary Secondary objective 1 Evaluate the Correlation of immunoglobulin levels and the development of Covid-19 antibodies. Two weeks after full dose vaccination.
Secondary Secondary objective 2 Evaluate the correlation of CD4/CD8 counts with the development of Covid-19 antibodies. Two weeks after full dose vaccination.
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