Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients

NCT04922944 | Completed FDA Drug

• 1 other identifier: Pro00050032
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Vaccine Reaction

Keywords

SARS-CoV-2; vaccination; antibody formation

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Occurrence of post-vaccine reactions

  Within 3 days after vaccine injections

• Severity of post-vaccine reactions

  Within 3 days after vaccine injections

Interventions

COVID-19 vaccine DRUG

Two-dose COVID-19 vaccine

Also known as: Pfizer-BioNTech COVID-19 vaccine, Moderna COVID-19 vaccine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huntington Memorial Hospital: lead

Study Sites (1)

Huntington Hospital

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines; BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Kimberly Shriner, MD

  Huntington Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: June 11, 2021
• Study Start: March 8, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)