AzTrials
AzTrials

COVID-19 BoosterNCT05476822

Profiling Spike Protein Antibody Response Post COVID-19 Booster

An observational study of COVID-19 Booster and Spike Protein IgG Antibody, run by David Grant U.S. Air Force Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Booster, Spike Protein IgG Antibody
What is being tested?
Obtain antibody titers
Type of treatment
Vaccines
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2022to Jun 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson \& Johnson) and booster.

Who may be able to join

  • Adults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson \& Johnson) and booster.

Who cannot join

  • Unvaccinated, partially vaccinated, or unable to provide proof of COVID vaccination
  • Unwilling or medically unable to have an initial or follow up blood sample drawn
  • Positive COVID test after receiving COVID booster
  • Current history of a bleeding disorder, cancer, or are immunocompromised
  • Received a COVID vaccine booster seven or more months ago

About this study

A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.

Read the detailed description

This is primarily a descriptive study that will quantify with 95% confidence intervals the mean IgG antibodies remaining in vaccinated healthy participants three to nine months after their COVID booster. At specified intervals during this period, a titer will be performed on blood drawn from participants to quantify the IgG antibodies to the SARS-CoV-2 spike protein.

This evaluation will not be performed in a lab with CLIA certification and this study will not be used to seek an EUA from the FDA. The FDA and CLIA regulate diagnostic laboratory testing but do not regulate surveillance testing.

Being tested
Obtain antibody titers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Obtain antibody titersDiagnostic test

    Obtain blood samples for antibody titers at the time of enrollment, at three months, six months and nine months post vaccine booster (+/- ten days).

Study groups in NCT05476822
Study groupRoleWhat they receive
Adults who received a full course of COVID-19 vaccine and boosterAdults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson \& Johnson) and booster will have antibody titers performed from blood drawn at time of enrollment, at three months, six months and nine months post vaccine booster (+/- ten days).
Receives: Diagnostic Test: Obtain antibody titers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of IgG antibody for SARS-CoV-2 spike protein at baseline (0-2.5 months post booster)

    Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants at baseline (0-2.5 months post COVID booster).

    Measured: Within 2.5 months post COVID booster

  2. Level of IgG antibody for SARS-CoV-2 spike protein 3 months post COVID booster

    Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 3 months post COVID booster.

    Measured: within 3 months post COVID booster

  3. Level of IgG antibody for SARS-CoV-2 spike protein 6 months post COVID booster

    Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 6 months post COVID booster.

    Measured: within 6 months post COVID booster

  4. Level of IgG antibody for SARS-CoV-2 spike protein 9 months post COVID booster

    Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 9 months post COVID booster.

    Measured: within 9 months post COVID booster

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study startAug 2022 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Why it stopped: Not submitted for IRB approval. No participants were enrolled

Resources

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
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05476822
Sponsor's protocol ID
FDG20210028H
Status last verified
Mar 2023
First submitted
25 Jul 2022
Last updated
24 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thakkar A, Gonzalez-Lugo JD, Goradia N, Gali R, Shapiro LC, Pradhan K, Rahman S, Kim SY, Ko B, Sica RA, Kornblum N, Bachier-Rodriguez L, McCort M, Goel S, Perez-Soler R, Packer S, Sparano J, Gartrell B, Makower D, Goldstein YD, Wolgast L, Verma A, Halmos B. Seroconversion rates following COVID-19 vaccination among patients with cancer. Cancer Cell. 2021 Aug 9;39(8):1081-1090.e2. doi: 10.1016/j.ccell.2021.06.002. Epub 2021 Jun 5.

    PubMed 34133951

  • Kyriakidis NC, Lopez-Cortes A, Gonzalez EV, Grimaldos AB, Prado EO. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates. NPJ Vaccines. 2021 Feb 22;6(1):28. doi: 10.1038/s41541-021-00292-w.

    PubMed 33619260

  • Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016 Jun 30;60(1):111-20. doi: 10.1042/EBC20150012.

    PubMed 27365041

  • Schuler CF 4th, Gherasim C, O'Shea K, Manthei DM, Chen J, Giacherio D, Troost JP, Baldwin JL, Baker JR Jr. Accurate point-of-care serology tests for COVID-19. PLoS One. 2021 Mar 16;16(3):e0248729. doi: 10.1371/journal.pone.0248729. eCollection 2021.

    PubMed 33725025

  • Karim SSA, Karim QA. Omicron SARS-CoV-2 variant: a new chapter in the COVID-19 pandemic. Lancet. 2021 Dec 11;398(10317):2126-2128. doi: 10.1016/S0140-6736(21)02758-6. Epub 2021 Dec 3. No abstract available.

    PubMed 34871545

  • Kannan SR, Spratt AN, Sharma K, Chand HS, Byrareddy SN, Singh K. Omicron SARS-CoV-2 variant: Unique features and their impact on pre-existing antibodies. J Autoimmun. 2022 Jan;126:102779. doi: 10.1016/j.jaut.2021.102779. Epub 2021 Dec 13.

    PubMed 34915422

  • Walayat S, Ahmed Z, Martin D, Puli S, Cashman M, Dhillon S. Recent advances in vaccination of non-responders to standard dose hepatitis B virus vaccine. World J Hepatol. 2015 Oct 28;7(24):2503-9. doi: 10.4254/wjh.v7.i24.2503.

    PubMed 26523203

  • CDC COVID-19 Response Team. SARS-CoV-2 B.1.1.529 (Omicron) Variant - United States, December 1-8, 2021. MMWR Morb Mortal Wkly Rep. 2021 Dec 17;70(50):1731-1734. doi: 10.15585/mmwr.mm7050e1.

    PubMed 34914670

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Booster and Spike Protein IgG Antibody, run by David Grant U.S. Air Force Medical Center.

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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Level of IgG antibody for SARS-CoV-2 spike protein at baseline (0-2.5 months post booster) (time frame: Within 2.5 months post COVID booster). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05476822, which also lists 8 linked publications.

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 24 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in