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

NCT04779996 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2021-03-03

No results posted yet for this study

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.

Conditions

  • Covid19
  • Cancer
  • HIV Infections

Interventions

DIAGNOSTIC_TEST

Laboratory 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 & Collaborators

  • Auxilio Mutuo Cancer Center

    lead OTHER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2021-08-31
Completion
2022-02-28

Countries

  • Puerto Rico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04779996 on ClinicalTrials.gov