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OpenTrials
Completed

NCT Number: NCT04922944

Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Reaction Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Huntington Hospital

Pasadena, California, 91105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 vaccine

Drug

Two-dose COVID-19 vaccine

Other names: Pfizer-BioNTech COVID-19 vaccine, Moderna COVID-19 vaccine

Primary outcomes

  1. Change in SARS-CoV-2 IgG Titer Over Time

    Time frame: 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

    Semi-quantitative SARS-CoV-2 IgG titer

Secondary outcomes

  1. Occurrence of post-vaccine reactions

    Time frame: Within 3 days after vaccine injections

    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

  2. Severity of post-vaccine reactions

    Time frame: Within 3 days after vaccine injections

    Subjective reporting of severity of post-vaccine reactions (none, mild, moderate, or severe)

Sponsors and collaborators

Lead sponsor

Huntington Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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