Profiling Spike Protein Antibody Response Post COVID Booster
Study Details
Study Description
Brief Summary
A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Obtain blood samples for antibody titers at the time of enrollment, at three months, six months and nine months post vaccine booster (+/- ten days).
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Outcome Measures
Primary Outcome Measures
- Level of IgG antibody for SARS-CoV-2 spike protein at baseline (0-2.5 months post booster) [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 [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 [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 [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.
Eligibility Criteria
Criteria
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:
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Unvaccinated, partially vaccinated, or unable to provide proof of COVID vaccination
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Unwilling or medically unable to have an initial or follow up blood sample drawn
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Positive COVID test after receiving COVID booster
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Current history of a bleeding disorder, cancer, or are immunocompromised
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Received a COVID vaccine booster seven or more months ago
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- David Grant U.S. Air Force Medical Center
Investigators
- Principal Investigator: Nolan R Hudson, MS, David Grant Medical Center, Travis AFB, CA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- 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
- COVID Data Tracker - Variant proportions
Publications
- 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.
- 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.
- 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. Erratum in: Lancet. 2022 Jan 8;399(10320):142.
- Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016 Jun 30;60(1):111-20. doi: 10.1042/EBC20150012. Review.
- Kyriakidis NC, López-Cortés A, González 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. Review.
- 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.
- 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.
- 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. Review.
- FDG20210028H