COVID-19 Quantitative Antibody Titers & Booster Vaccinations

NCT05104359 | Completed

• 1 other identifier: COL2021-001
• Study Type: observational
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study aiming at describing COVID-19 vaccination outcomes among HIV-positive and HIV-negative individuals, using electronic health records to observe their usual clinical care. This study will describe levels of COVID-19 vaccine response (i.e., Ig spike antibody measurements). Rates of antibody level decay after vaccination will be assessed. The efficacy of using antibody levels to help guide the timing of booster doses among HIV-negative and HIV-positive patients will be evaluated.

Conditions

COVID-19; COVID-19 Vaccines; Immunogenicity, Vaccine

Keywords

COVID-19; Observational; Vaccination; Antibody; Booster

Outcome Measures

Primary Outcomes (1)

• Vaccine Response

  Levels of Roche SARS-CoV-2 Semi-Quant Spike Ig antibody

  >21 days

Interventions

Observational OTHER

HIV-positive versus HIV-negative patients, individuals with at least 2 measurements of antibody levels, and boosted individuals are the subgroups of interest.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals presenting for care at AHF Midtown Manhattan Healthcare Center who received COVID-19 vaccination and antibody testing; followed through their electronic health records in the OPERA Observational Database.

You may qualify if:

• Cared for at AHF Midtown Manhattan Healthcare Center and followed in the OPERA observational database
• Active in care in the last 24 months
• Fully vaccinated against SARS-CoV-2 virus, implemented as 21 days after the second Pfizer or Moderna injections, 21 days after the one J\&J injection
• Received a Roche SARS-CoV-2 Semi-Quant Spike Ig AB test after full vaccination as usual clinical care

You may not qualify if:

• Unvaccinated or partially vaccinated against SARS-CoV-2 virus
• Never tested with a SARS-CoV-2 Semi-Quant Total AB test after full vaccination

Sponsors & Collaborators

• Epividian: lead
• AIDS Healthcare Foundation: collaborator

Study Sites (1)

AHD Manhattan Midtown HCC

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Watchful Waiting

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)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Ricky Hsu, MD

  AHF Midtown Manhattan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 3, 2021
• Study Start: December 11, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)