Host Immune Response to Novel RNA COVID-19 Vaccination | NCT04784689

Studies
Host Immune Response to Novel RNA COVID-19 Vaccination

NCT04784689

Sponsor

The University of Texas Health Science Center at San Antonio

Status

Completed

Last Update Posted

May 25, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

COVID-19 Vaccine
Cancer

Interventions

COVID-19 Vaccine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2021Actual

Primary Completion Date

May 18, 2022Actual

Completion Date

May 18, 2022Actual

First Submitted Date

Mar 3, 2021

First Submission Date that Met QC Criteria

Mar 4, 2021

First Posted Date

Mar 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2023

Last Update Posted Date

May 25, 2023Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Prospective - Cancer Patients that have received COVID-19 Vaccination			Biological: COVID-19 Vaccine

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 Vaccine	Biological	COVID-19 Vaccine	Prospective - Cancer Patients that have received COVID-19 Vaccination

Measure	Description	Time Frame
Antibody response level in patients with cancer to the COVID-19 vaccination.	Antibody response change over time	Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mays Cancer Center patients eligible to receive the COVID-19 vaccination.

Sampling Method

Non-Probability Sample

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures