COVID-19 VaccineNCT04784689
Host Immune Response to Novel RNA COVID-19 Vaccination
An observational study of COVID-19 Vaccine and Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
To determine the antibody response level in patients with cancer to the COVID-19 vaccination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Vaccine, Cancer
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 18 May 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Mays Cancer Center patients eligible to receive the COVID-19 vaccination.
Who may be able to join
- Age 18 years or older
- Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
- Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
- Able to provide informed consent
- Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.
Who cannot join
- Previously documented COVID infection
- Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
- Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:
- Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
- Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])
- Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
- Pregnant or breastfeeding
- Unable to comply with study related procedures as determined by the study team.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: Host Immune Response to Novel RNA COVID-19 Vaccination in Patients With Cancer (CTMS# 21-0012)
To determine the antibody response level in patients with cancer to the COVID-19 vaccination.
- Conditions
- COVID-19 Vaccine, Cancer
- Being tested
- COVID-19 Vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
COVID-19 Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Prospective - Cancer Patients that have received COVID-19 Vaccination | Not described Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response level in patients with cancer to the COVID-19 vaccination.
Antibody response change over time
Measured: Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start24 Feb 2021
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Lathrop, The University of Texas Health Science Center at San Antonio
- Investigators
- Dimpy Shah, MD PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784689
- Sponsor's protocol ID
- CTMS 21-0012
- Status last verified
- May 2023
- First submitted
- 3 Mar 2021
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Immune Response to Novel RNA COVID-19 Vaccination in Patients With Cancer (CTMS# 21-0012)
- ClinicalTrials.gov ID
- NCT04784689
- Acronym / sponsor ID
- CTMS 21-0012
- Conditions
- COVID-19 Vaccine, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 5 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.
To determine the antibody response level in patients with cancer to the COVID-19 vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective - Cancer Patients that have received COVID-19 Vaccination | – | Biological: COVID-19 Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mays Cancer Center patients eligible to receive the COVID-19 vaccination.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
- Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
- Able to provide informed consent
- Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.
Key exclusion criteria (8 listed)
- Previously documented COVID infection
- Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
- Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:
- Pregnant or breastfeeding
- Unable to comply with study related procedures as determined by the study team.
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 |
|---|---|---|
| COVID-19 VaccineCOVID-19 Vaccine | Biological | Prospective - Cancer Patients that have received COVID-19 Vaccination |
Primary outcome
Antibody response level in patients with cancer to the COVID-19 vaccination.
Time frame: Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months
Antibody response change over time
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 25 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Dimpy Shah, MD PhD principal investigator
The University of Texas Health Science Center at San Antonio
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 COVID-19 Vaccine and Cancer, run by The University of Texas Health Science Center at San Antonio 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 5 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 25 May 2023. 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?
Antibody response level in patients with cancer to the COVID-19 vaccination. (time frame: Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months). 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 25 May 2023.