Profiling Spike Protein Antibody Response Post COVID-19 Booster

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2023

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.

Interventions

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

Arms, Groups and Cohorts

  • Adults who received a full course of COVID-19 vaccine and booster
    • 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 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants at baseline (0-2.5 months post COVID booster).
  • Level of IgG antibody for SARS-CoV-2 spike protein 3 months post COVID booster
    • Time Frame: within 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.
  • Level of IgG antibody for SARS-CoV-2 spike protein 6 months post COVID booster
    • Time Frame: within 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.
  • Level of IgG antibody for SARS-CoV-2 spike protein 9 months post COVID booster
    • Time Frame: within 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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. Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • David Grant U.S. Air Force Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nolan Hudson, Research Associate/Medical Technologist – David Grant U.S. Air Force Medical Center
  • Overall Official(s)
    • Nolan R Hudson, MS, Principal Investigator, David Grant Medical Center, Travis AFB, CA

References

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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.

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

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.

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. Erratum In: Lancet. 2022 Jan 8;399(10320):142.

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.

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.

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.

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