Clinical trial NCT04922944: Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients
Official title: Post Vaccination Antibody Assays and Reactions in Hospital Employees and Medical Staff: an Analysis of Antibody Response Over Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Vaccine Reaction
Keywords: SARS-CoV-2
vaccination
antibody formation
Lead sponsor: Huntington Memorial Hospital
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 167
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA who has completed the vaccination regimen

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.

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

Primary outcomes:
measure: Change in SARS-CoV-2 IgG Titer Over Time
timeFrame: 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: Occurrence of post-vaccine reactions
timeFrame: Within 3 days after vaccine injections
measure: Severity of post-vaccine reactions
timeFrame: Within 3 days after vaccine injections
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Hospital
state: California
Study officials:
affiliation: Huntington Hospital
name: Kimberly Shriner, MD
role: PRINCIPAL_INVESTIGATOR
References: