COVID-19NCT05104359
COVID-19 Quantitative Antibody Titers & Booster Vaccinations
An observational study of COVID-19 and COVID-19 Vaccines, run by Epividian at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID-19 Vaccines, Immunogenicity, Vaccine
- What is being tested?
- Observational
- How many people
- 825 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unvaccinated or partially vaccinated against SARS-CoV-2 virus
- Never tested with a SARS-CoV-2 Semi-Quant Total AB test after full vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Should COVID-19 Quantitative Antibody Titers be Implemented to Guide COVID-19 Booster Vaccinations Regardless of HIV Status, Immunosuppression, or Age?
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.
Read the 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.
- Conditions
- COVID-19, COVID-19 Vaccines, Immunogenicity, Vaccine
- Being tested
- Observational
- Keywords
- COVID-19, Observational, Vaccination, Antibody, Booster
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
HIV-positive versus HIV-negative patients, individuals with at least 2 measurements of antibody levels, and boosted individuals are the subgroups of interest.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Response
Levels of Roche SARS-CoV-2 Semi-Quant Spike Ig antibody
Measured: >21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start11 Dec 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epividian
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation
- Responsible party
- Sponsor
- Investigators
- Ricky Hsu, MD, Principal investigator, AHF Midtown Manhattan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104359
- Sponsor's protocol ID
- COL2021-001
- Status last verified
- Jul 2022
- First submitted
- 1 Nov 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should COVID-19 Quantitative Antibody Titers be Implemented to Guide COVID-19 Booster Vaccinations Regardless of HIV Status, Immunosuppression, or Age?
- ClinicalTrials.gov ID
- NCT05104359
- Acronym / sponsor ID
- COL2021-001
- Conditions
- COVID-19, COVID-19 Vaccines, Immunogenicity, Vaccine
- Keywords
- COVID-19, Observational, Vaccination, Antibody, Booster
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- EpividianIndustry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unvaccinated or partially vaccinated against SARS-CoV-2 virus
- Never tested with a SARS-CoV-2 Semi-Quant Total AB test after full vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalHIV-positive versus HIV-negative patients, individuals with at least 2 measurements of antibody levels, and boosted individuals are the subgroups of interest. | Other | – |
Primary outcome
Vaccine Response
Time frame: >21 days
Levels of Roche SARS-CoV-2 Semi-Quant Spike Ig antibody
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricky Hsu, MD principal investigator
AHF Midtown Manhattan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and COVID-19 Vaccines, run by Epividian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Response (time frame: >21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.