Clinical trial NCT05104359: COVID-19 Quantitative Antibody Titers & Booster Vaccinations
Official title: Should COVID-19 Quantitative Antibody Titers be Implemented to Guide COVID-19 Booster Vaccinations Regardless of HIV Status, Immunosuppression, or Age?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
COVID-19 Vaccines
Immunogenicity, Vaccine
Keywords: COVID-19
Observational
Vaccination
Antibody
Booster
Lead sponsor: Epividian
Sponsor class: INDUSTRY
Collaborators: name: AIDS Healthcare Foundation
First posted: 2021-11-03
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: The aim of this study is to assess levels of COVID-19 vaccine response through measuring surrogate Ig spike antibody measurements, to determine the rates of antibody level decay after vaccination, and to measure the efficacy of utilizing these antibody measurements to help guide the timing of booster doses among HIV-negative and HIV-positive patients.

The study population will include adults who were fully vaccinated against SARS-CoV-2 virus (i.e., two doses of Pfizer or Moderna vaccines or one dose of the J\&J vaccine), and have received a Roche SARS-CoV-2 Semi-Quant Spike Ig Ab test at least 3 weeks after full vaccination as part of their usual clinical care at AHF Midtown Manhattan Healthcare Center.

Incidence rates of COVID vaccine response levels (i.e., adequate, low, non-response) will be estimated using univariate Poisson regression, overall and by vaccine type. Among individuals with at least two antibody measurements, rates of antibody levels decay will be estimated using univariate linear regression, overall and stratified by HIV status, vaccine type and baseline CD4 cell count. In the sub-population of individuals who received a COVID vaccine booster, vaccination and antibody response will be characterized at least 3 weeks after the booster is received. Univariate linear regression will be used to estimate rates of antibody levels decay, among individuals with at least two antibody measurements, including one after the booster dose. Rates of response decay will be produced overall, and stratified by HIV status, booster type and baseline CD4 cell count.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Vaccine Response
timeFrame: >21 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: AHD Manhattan Midtown HCC
state: New York
Study officials:
affiliation: AHF Midtown Manhattan
name: Ricky Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: