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Not submitted for IRB approval. No participants were enrolled
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A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nolan R Hudson, MS | David Grant Medical Center, Travis AFB, CA | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34133951 | Background | 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. | |
| 33619260 |
| Label | URL |
|---|---|
| World-wide tracking of coronavirus cases, deaths and vaccine doses administered | View source |
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blood serum samples
| 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. |
| 27365041 | Background | Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016 Jun 30;60(1):111-20. doi: 10.1042/EBC20150012. |
| 33725025 | 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. |
| 34871545 | 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. |
| 34915422 | 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. |
| 26523203 | 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. |
| 34914670 | 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. |
| COVID-19 Vaccine Breakthrough Infections Reported to CDC - United States, January 1-April 30, 2021 | View source |
| Reduced Neutralization of SARS-CoV-2 Omicron Variant by Vaccine Sera and Monoclonal Antibodies | View source |
| SARS-CoV-2 Omicron has extensive but incomplete escape of Pfizer BNT162b2 elicited neutralization and requires ACE2 for infection | View source |
| What Do We Know About the New COVID variant Omicron | View source |
| Department of Health, Government of South Africa | View source |