Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2021
CompletedFirst Submitted
Initial submission to the registry
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedMarch 3, 2021
March 1, 2021
7 months
March 2, 2021
March 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Secondary objective 1
Two weeks after full dose vaccination.
Secondary objective 2
Two weeks after full dose vaccination.
Interventions
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.
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Auxilio Mutuo Cancer Center
San Juan, 00918, Puerto Rico
Related 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.
PMID: 32671831BACKGROUNDHouot 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.
PMID: 32619884BACKGROUNDMcLaughlin 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.
PMID: 9704735BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fernando Cabanillas, MD
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 3, 2021
Study Start
February 16, 2021
Primary Completion
August 31, 2021
Study Completion
February 28, 2022
Last Updated
March 3, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share