Profiling Spike Protein Antibody Response Post COVID-19 Booster

NCT05476822 | Withdrawn

• 1 other identifier: FDG20210028H
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

COVID-19 Booster; Spike Protein IgG Antibody

Outcome Measures

Primary Outcomes (4)

• 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).

  Within 2.5 months post COVID booster

• 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.

  within 3 months post COVID booster

• 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.

  within 6 months post COVID booster

• 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.

  within 9 months post COVID booster

Study Arms (1)

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).

Diagnostic Test: Obtain antibody titers

Interventions

Obtain antibody titers DIAGNOSTIC_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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Related Publications (8)

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  PMID: 34133951 BACKGROUND

• 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.

  PMID: 33619260 BACKGROUND

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

  PMID: 27365041 BACKGROUND

• 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.

  PMID: 33725025 BACKGROUND

• 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.

  PMID: 34871545 BACKGROUND

• 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.

  PMID: 34915422 BACKGROUND

• 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.

  PMID: 26523203 BACKGROUND

• 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.

  PMID: 34914670 BACKGROUND

Related Links

• World-wide tracking of coronavirus cases, deaths and vaccine doses administered
• COVID-19 Vaccine Breakthrough Infections Reported to CDC - United States, January 1-April 30, 2021
• Reduced Neutralization of SARS-CoV-2 Omicron Variant by Vaccine Sera and Monoclonal Antibodies
• SARS-CoV-2 Omicron has extensive but incomplete escape of Pfizer BNT162b2 elicited neutralization and requires ACE2 for infection
• What Do We Know About the New COVID variant Omicron
• Department of Health, Government of South Africa

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum samples

Study Officials

• Nolan R Hudson, MS

  David Grant Medical Center, Travis AFB, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate/Medical Technologist

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: August 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03