COVID-19 Clinical Trial
Official title:
Should COVID-19 Quantitative Antibody Titers be Implemented to Guide COVID-19 Booster Vaccinations Regardless of HIV Status, Immunosuppression, or Age?
Verified date | July 2022 |
Source | Epividian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 825 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | AHD Manhattan Midtown HCC | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Epividian | AIDS Healthcare Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaccine Response | Levels of Roche SARS-CoV-2 Semi-Quant Spike Ig antibody | >21 days |
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