Covid19NCT04779996
Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment
An observational study of Covid19 and Cancer, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Covid19, Cancer, HIV Infections
- What is being tested?
- Laboratory Samples
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 250 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 16 Feb 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients either diagnosed with cancer or with HIV positivity or treated with an antineoplastic regimen including anti CD-20 after Covid-19 vaccine.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site, 1 recruiting
- Recruiting
Auxilio Mutuo Cancer Center
San Juan, 00918
Fernando Cabanillas, MD, 787-758-2000 ext. 3503, cabanillasmd@gmail.com
Carmen Morales, 787-758-2000 ext. 3503, camorales@auxiliomutuo.com
About this study
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
- Being tested
- Laboratory Samples
- Medical subject headings
- COVID-19, Neoplasms, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory SamplesDiagnostic test
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Antibody Production defined as: 1. Positive serologic Covid-19 antibodies rapid test against S protein.
Measured: Two weeks after full dose vaccination.
Secondary outcomes (2)
Secondary objective 1
Evaluate the Correlation of immunoglobulin levels and the development of Covid-19 antibodies.
Measured: Two weeks after full dose vaccination.
Secondary objective 2
Evaluate the correlation of CD4/CD8 counts with the development of Covid-19 antibodies.
Measured: Two weeks after full dose vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start16 Feb 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auxilio Mutuo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Cabanillas, Auxilio Mutuo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779996
- Sponsor's protocol ID
- CCAM 21-01
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32671831Houot 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.
PubMed 32619884McLaughlin 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.
PubMed 9704735
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment
- ClinicalTrials.gov ID
- NCT04779996
- Acronym / sponsor ID
- CCAM 21-01
- Conditions
- Covid19, Cancer, HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Auxilio Mutuo Cancer CenterUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients either diagnosed with cancer or with HIV positivity or treated with an antineoplastic regimen including anti CD-20 after Covid-19 vaccine.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Samples1. 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. | Diagnostic test | – |
Primary outcome
Primary Objective
Time frame: 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.
2 secondary outcomes
Secondary objective 1
Time frame: Two weeks after full dose vaccination.
Secondary objective 2
Time frame: Two weeks after full dose vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 32671831Baker 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.
- Background: PubMed 32619884Houot 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.
- Background: PubMed 9704735McLaughlin 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.
- OpenSAFELY: factors associated with COVID-19-related hospital death in the linked electronic health records of 17 million adult NHS patients.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Cancer, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Cabanillas, MD (787-758-2000 ext. 3503, cabanillasmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Two weeks after full dose vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779996, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.