Covid19Early Phase 1NCT04936997
Immune Response to the COVID-19 Vaccine
A Early Phase 1 study testing SARS-COV2 Pfizer Vaccine in people with Covid19 and Cancer, run by University of Arizona at 1 site in United States.
Trial summary
Explore the effects on immune response to include a potential third vaccine for the cancer cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Cancer, Malignancy
- What is being tested?
- SARS-COV2 Pfizer Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 8 May 2022
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have active solid tumor malignancy diagnosis
- On active chemotherapy
- Received two prior SARS-COV2 Pfizer vaccines
- Age ≥ 18 years
- Ability to understand and the willingness to sign a written informed consent
- Agree to comply with study procedures
- Subjects previously enrolled under the main study
Who cannot join
- History of HIV or organ/bone marrow transplant
- Actively receiving immunotherapy
- On active, chronic immunosuppression (>10 mg daily dose of prednisone equivalent)
- Currently incarcerated or residence of another state
- Speaks a language other than English.
Trial locations and contacts
1 site in 1 country.
About this study
Explore the effects on immune response to include a potential third vaccine for the cancer cohort.
Read the detailed description
In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.
- Conditions
- Covid19, Cancer, Malignancy, Vaccine Response Impaired
- Being tested
- SARS-COV2 Pfizer Vaccine
- Keywords
- Covid-19 vaccine, Pfizer Covid-a9 vaccine, Covid vaccine study
- 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.
SARS-COV2 Pfizer VaccineBiological
Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
| Study group | Role | What they receive |
|---|---|---|
| 3rd COVID-19 vaccine (2nd booster) | Experimental | Patients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine. Receives: Biological: SARS-COV2 Pfizer Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response
Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by antibody quantification in blood samples.
Measured: 3 months
Secondary outcomes (1)
Adverse events
Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by T-cell quantification in blood samples.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start7 Jun 2021
- Primary completion25 Aug 2021
- Study completion8 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachna Shroff, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936997
- Sponsor's protocol ID
- 2012325795-B
- Status last verified
- May 2022
- First submitted
- 18 Jun 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Shroff RT, Chalasani P, Wei R, Pennington D, Quirk G, Schoenle MV, Peyton KL, Uhrlaub JL, Ripperger TJ, Jergovic M, Dalgai S, Wolf A, Whitmer R, Hammad H, Carrier A, Scott AJ, Nikolich-Zugich J, Worobey M, Sprissler R, Dake M, LaFleur BJ, Bhattacharya D. Immune responses to two and three doses of the BNT162b2 mRNA vaccine in adults with solid tumors. Nat Med. 2021 Nov;27(11):2002-2011. doi: 10.1038/s41591-021-01542-z. Epub 2021 Sep 30.
PubMed 34594036
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to the COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT04936997
- Acronym / sponsor ID
- 2012325795-B
- Conditions
- Covid19, Cancer, Malignancy, Vaccine Response Impaired
- Keywords
- Covid-19 vaccine, Pfizer Covid-a9 vaccine, Covid vaccine study
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 8 May 2022 (actual)
- First posted
- 23 Jun 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.
Explore the effects on immune response to include a potential third vaccine for the cancer cohort.
Detailed description
In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3rd COVID-19 vaccine (2nd booster) | Experimental | Biological: SARS-COV2 Pfizer VaccinePatients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have active solid tumor malignancy diagnosis
- On active chemotherapy
- Received two prior SARS-COV2 Pfizer vaccines
- Age ≥ 18 years
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (5 listed)
- History of HIV or organ/bone marrow transplant
- Actively receiving immunotherapy
- On active, chronic immunosuppression (>10 mg daily dose of prednisone equivalent)
- Currently incarcerated or residence of another state
- Speaks a language other than English.
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 |
|---|---|---|
| SARS-COV2 Pfizer VaccineVaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). | Biological | 3rd COVID-19 vaccine (2nd booster) |
Primary outcome
Immune response
Time frame: 3 months
Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by antibody quantification in blood samples.
1 secondary outcome
Adverse events
Time frame: 3 months
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 20 May 2022.
- Derived from this study: PubMed 34594036Shroff RT, Chalasani P, Wei R, Pennington D, Quirk G, Schoenle MV, Peyton KL, Uhrlaub JL, Ripperger TJ, Jergovic M, Dalgai S, Wolf A, Whitmer R, Hammad H, Carrier A, Scott AJ, Nikolich-Zugich J, Worobey M, Sprissler R, Dake M, LaFleur BJ, Bhattacharya D. Immune responses to two and three doses of the BNT162b2 mRNA vaccine in adults with solid tumors. Nat Med. 2021 Nov;27(11):2002-2011. doi: 10.1038/s41591-021-01542-z. Epub 2021 Sep 30.
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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.
Rachna Shroff, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SARS-COV2 Pfizer Vaccine in people with Covid19 and Cancer, run by University of Arizona 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 7 inclusion and 5 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 20 May 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Immune response (time frame: 3 months). 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 NCT04936997, which also lists 1 linked publication.
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 20 May 2022.