Clinical trial NCT05476822: Profiling Spike Protein Antibody Response Post COVID-19 Booster
Official title: Profiling Spike Protein Antibody Response Post COVID-19 Booster
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19 Booster
Spike Protein IgG Antibody
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2022-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Level of IgG antibody for SARS-CoV-2 spike protein at baseline (0-2.5 months post booster)
timeFrame: Within 2.5 months post COVID booster
measure: Level of IgG antibody for SARS-CoV-2 spike protein 3 months post COVID booster
timeFrame: within 3 months post COVID booster
measure: Level of IgG antibody for SARS-CoV-2 spike protein 6 months post COVID booster
timeFrame: within 6 months post COVID booster
measure: Level of IgG antibody for SARS-CoV-2 spike protein 9 months post COVID booster
timeFrame: within 9 months post COVID booster
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: David Grant Medical Center, Travis AFB, CA
name: Nolan R Hudson, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016 Jun 30;60(1):111-20. doi: 10.1042/EBC20150012.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.