Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05104359 |
| Other study ID # |
COL2021-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 11, 2020 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Epividian |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
