Post COVID-19 Vaccination Analysis in Healthcare Worker R... | NCT04922944

Studies
Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients

NCT04922944

Sponsor

Huntington Memorial Hospital

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

167Actual

Phase

Not provided

Conditions

Covid19
Vaccine Reaction

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

Sep 2024

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

Mar 8, 2021Actual

Primary Completion Date

Mar 1, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Mar 30, 2021

First Submission Date that Met QC Criteria

Jun 9, 2021

First Posted Date

Jun 11, 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

Sep 11, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research study is studying how healthcare worker recipients react after receiving vaccinations for COVID-19. The objective of the study is to evaluate the immune response to COVID-19 vaccination. The immunity will be evaluated over time by measuring serum semi-quantitative SARS-Co-V2 IgG from blood specimens and analyzing vaccine reaction data. SARS-CoV-2 is the name for the virus responsible for COVID-19 infections. IgG, immunoglobulin G, is an antibody found in the blood that protects against bacterial and viral infections. Study subjects will also be asked to report physical reactions they may have experienced related to vaccinations.

Detailed Description

As some of the first recipients of SARS-CoV-2 vaccines under emergency authorization use, healthcare workers represent a diverse subpopulation, that are now moving through the immune response to the Pfizer and Moderna mRNA vaccines. As individual responses may vary, this provides an opportunity to evaluate levels of IgG response in relation to age, gender, comorbidities and other factors that may influence immunity. We recognize that, though this is only part of the immune response that may be protective for severe COVID-19 disease, it is a first step in understanding the level and durability of post vaccination SARS-CoV-2 antibodies.

This small, pilot study will evaluate the immune response over time by measuring serum semi-quantitative SARS-CoV-2 IgG from healthcare vaccinees at various timepoints. A high-level review of reactions related to the vaccinations will be performed with the same population of healthcare workers.

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

167Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 vaccine	Drug	Two-dose COVID-19 vaccine		Pfizer-BioNTech COVID-19 vaccine Moderna COVID-19 vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in SARS-CoV-2 IgG Titer Over Time	Semi-quantitative SARS-CoV-2 IgG titer	8 weeks (± 5 days) post-vaccination regimen completion; 24 weeks (± 5 days) post-vaccination regimen completion; and 52 weeks (± 5 days) post-vaccination regimen completion

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of post-vaccine reactions	Subjective reporting of occurrence of post-vaccination reactions including anaphylactic reactions (such as difficulty breathing, swelling of face and throat, fast heartbeat, bad rash all over body, and dizziness and weakness); injection site pain; injection site swelling/hardness; injection site redness; tiredness; headache; muscle pain; chills; join pain; fever; nausea; feeling unwell; and/or swollen lymph nodes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent for study
Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA, (must have valid hospital identification)
Must have completed vaccination regimen (two doses if required) no more than 8 weeks ± 5 days before enrollment
Must have completed, valid vaccination card, if vaccinations received at a center other than Huntington Hospital
Able to read English, sign consent form and complete on-line surveys

Exclusion Criteria:

Huntington Hospital employees on leave of absence
Anyone not able/willing to provide blood specimens and respond to surveys for the 52-week study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA who has completed the vaccination regimen

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kimberly Shriner, MD	Huntington Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huntington Hospital		Pasadena	California	91105	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000086663	COVID-19 Vaccines
D000090982	BNT162 Vaccine
D000090983	2019-nCoV Vaccine mRNA-1273

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided