Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients

Covid19 Clinical Trial

Official title:

Post Vaccination Antibody Assays and Reactions in Hospital Employees and Medical Staff: An Analysis of Antibody Response Over Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922944
• Other study ID #: Pro00050032
• Status: Completed
• Start date: March 8, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Huntington Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Vaccine Reaction

Intervention

Drug:
• COVID-19 vaccine
Two-dose COVID-19 vaccine

Locations

Country	Name	City	State
United States	Huntington Hospital	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Huntington Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Within 3 days after vaccine injections
Secondary	Severity of post-vaccine reactions	Subjective reporting of severity of post-vaccine reactions (none, mild, moderate, or severe)	Within 3 days after vaccine injections