ClinicalTrials.gg
WithdrawnNCT05476822Updated Mar 24, 2023

Profiling Spike Protein Antibody Response Post COVID-19 Booster

An observational study in COVID-19 Booster and Spike Protein IgG Antibody, sponsored by David Grant U.S. Air Force Medical Center. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by David Grant U.S. Air Force Medical Center · Observational

Why this study was withdrawn
Not submitted for IRB approval. No participants were enrolled
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • COVID-19 Booster
  • Spike Protein IgG Antibody

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

David Grant U.S. Air Force Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • Received a COVID vaccine booster seven or more months ago
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

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).

    Diagnostic Test: Obtain antibody titers

Interventions

  • Diagnostic testObtain 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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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Within 2.5 months post COVID booster

  2. 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.

    Time frame: within 3 months post COVID booster

  3. 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.

    Time frame: within 6 months post COVID booster

  4. 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.

    Time frame: within 9 months post COVID booster

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 34133951 ↗
  • 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. PubMed 33619260 ↗
  • Koczula KM, Gallotta A. Lateral flow assays. Essays Biochem. 2016 Jun 30;60(1):111-20. doi: 10.1042/EBC20150012. PubMed 27365041 ↗
  • 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. PubMed 33725025 ↗
  • 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. doi: 10.1016/S0140-6736(21)02876-2. PubMed 34871545 ↗
  • 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. PubMed 34915422 ↗
  • 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. PubMed 26523203 ↗
  • 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. PubMed 34914670 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2022; primary completion for Jun 2023, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2022
First posted
Jul 27, 2022
StartEst.
Aug 2022
Primary completionEst.
Jun 2023
CompletionEst.
Jun 2023
Last update
Mar 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05476822
Lead sponsor
David Grant U.S. Air Force Medical Center
Responsible party
Nolan Hudson (Research Associate/Medical Technologist, David Grant U.S. Air Force Medical Center) — Principal investigator
First posted
Jul 27, 2022
Start date
Aug 2022 (estimated)
Primary completion
Jun 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Mar 24, 2023

Study contacts

Nolan R Hudson, MS
principal investigator · David Grant Medical Center, Travis AFB, CA

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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