Covid19NCT04854980
Serologic Response to the SARS-CoV-2 (COVID-19) MRNA-1273 Vaccine in Select Subsets of Oncology Patients
An observational study of Covid19 and Cancer, run by University of Rochester at 1 site in United States.
Trial summary
To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- What is being tested?
- Blood Sample
- Type of treatment
- Vaccines
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 23 Jul 2024
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are between 50 and 75 years of age
Who may be able to join
- Subjects are between 50 and 75 years of age;
- Have not had known or suspected infection with SARS-CoV-2 at any time;
- Subjects must fall into one of the following subsets of cancer patients:
- Localized prostate cancer on radiotherapy or have completed radiotherapy in the last three months
- Prostate cancer on androgen-deprivation therapy for biochemical recurrence
- Colon cancer on adjuvant chemotherapy for stage III disease
Show all 11Show fewer
- CLL on a BTK inhibitor as a first-line single agent for at least 3 months
- Melanoma patients on adjuvant immunotherapy with PD-1 checkpoint inhibitors for at least 3 months
- Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;
- Have at least a one-year life expectancy;
- Prior radiation therapy is allowed, as long as it was completed more than 6 months prior to vaccination
Who cannot join
- Subjects have a known hypersensitivity to a vaccine component;
- Have had known or suspected infection with SARS-CoV-2 at any time;
- Are organ transplant recipient on immunosuppression;
- Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;
- Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;
- Received high-dose corticosteroids at any time after receiving the vaccine;
- Are unable to give informed consent;
- Are receiving treatment for CLL with another agent (such as rituximab) in addition to a BTK inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serologic Response to the SARS-CoV-2 MRNA-1273 Vaccine in Select Subsets of Oncology Patients - a Pilot Study
To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.
Read the detailed description
The purpose of this study is to measure the immune response to the COVID-19 vaccine in cancer patients and compare to the general population. This information can help optimize the timing of the mRNA-1273 vaccine relative to starting treatment for cancer, adding booster immunizations or incorporation of medications that to enhance the immune response.
- Being tested
- Blood Sample
- Keywords
- Covid19, Cancer
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleOther
Blood sample, 2- to 5 tea spoon full (between 10 to 25 mL approximately) between 43 to 96 days after first dose of the vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: | Blood Sample Taken Receives: Other: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological response to the vaccine
Vaccine response, as determined by blood concentrations of serum IgG reactive to the RBD domain of spike protein from the original SARS-CoV-2 virus will be measured by ELISA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start3 Aug 2021
- Primary completion15 Mar 2022
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak Sahasrabudhe, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854980
- Sponsor's protocol ID
- UMLT21037
- Status last verified
- Sep 2023
- First submitted
- 20 Apr 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serologic Response to the SARS-CoV-2 MRNA-1273 Vaccine in Select Subsets of Oncology Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT04854980
- Acronym / sponsor ID
- UMLT21037
- Keywords
- Covid19, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 22 Apr 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.
To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.
Detailed description
The purpose of this study is to measure the immune response to the COVID-19 vaccine in cancer patients and compare to the general population. This information can help optimize the timing of the mRNA-1273 vaccine relative to starting treatment for cancer, adding booster immunizations or incorporation of medications that to enhance the immune response.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: | – | Other: Blood SampleBlood Sample Taken |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are between 50 and 75 years of age
Key inclusion criteria (11 listed)
- Subjects are between 50 and 75 years of age;
- Have not had known or suspected infection with SARS-CoV-2 at any time;
- Subjects must fall into one of the following subsets of cancer patients:
- Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;
- Have at least a one-year life expectancy;
Key exclusion criteria (8 listed)
- Subjects have a known hypersensitivity to a vaccine component;
- Have had known or suspected infection with SARS-CoV-2 at any time;
- Are organ transplant recipient on immunosuppression;
- Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;
- Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;
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 |
|---|---|---|
| Blood SampleBlood sample, 2- to 5 tea spoon full (between 10 to 25 mL approximately) between 43 to 96 days after first dose of the vaccine. | Other | Experimental: |
Primary outcome
Immunological response to the vaccine
Time frame: 1 year
Vaccine response, as determined by blood concentrations of serum IgG reactive to the RBD domain of spike protein from the original SARS-CoV-2 virus will be measured by ELISA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Rochester at 1 site in United States.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 30 Mar 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological response to the vaccine (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.