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Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) study: an observational cohort study of SARS-CoV-2 infection and vaccination in healthcare workers

Authors
  • Jackson-Thompson, Belinda M.1, 2
  • Goguet, Emilie1, 2
  • Laing, Eric D.1
  • Olsen, Cara H.3
  • Pollett, Simon2, 4
  • Hollis-Perry, K. Monique5
  • Maiolatesi, Santina E.2, 5
  • Illinik, Luca2, 4
  • Ramsey, Kathleen F.5, 6
  • Reyes, Anatalio E.5, 6
  • Alcorta, Yolanda5, 6
  • Wong, Mimi A.5, 6
  • Davies, Julian2, 4
  • Ortega, Orlando2, 4
  • Parmelee, Edward4
  • Lindrose, Alyssa R.1, 2
  • Moser, Matthew1, 2
  • Graydon, Elizabeth1
  • Letizia, Andrew G.5
  • Duplessis, Christopher A.5
  • And 12 more
  • 1 Uniformed Services University of the Health Science, Bethesda, MD, USA , Bethesda (United States)
  • 2 Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA , Bethesda (United States)
  • 3 Uniformed Services University of the Health Sciences, Bethesda, USA , Bethesda (United States)
  • 4 Uniformed Services University of the Health Sciences, Bethesda, MD, USA , Bethesda (United States)
  • 5 Naval Medical Research Center, Silver Spring, MD, USA , Silver Spring (United States)
  • 6 General Dynamics Information Technology, Falls Church, VA, USA , Falls Church (United States)
  • 7 Frederick National Laboratory for Cancer Research, Frederick, MD, USA , Frederick (United States)
Type
Published Article
Journal
BMC Infectious Diseases
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Jun 09, 2021
Volume
21
Issue
1
Identifiers
DOI: 10.1186/s12879-021-06233-1
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundSARS-CoV-2 is a recently emerged pandemic coronavirus (CoV) capable of causing severe respiratory illness. However, a significant number of infected people present as asymptomatic or pauci-symptomatic. In this prospective assessment of at-risk healthcare workers (HCWs) we seek to determine whether pre-existing antibody or T cell responses to previous seasonal human coronavirus (HCoV) infections affect immunological or clinical responses to SARS-CoV-2 infection or vaccination.MethodsA cohort of 300 healthcare workers, confirmed negative for SARS-CoV-2 exposure upon study entry, will be followed for up to 1 year with monthly serology analysis of IgM and IgG antibodies against the spike proteins of SARS-CoV-2 and the four major seasonal human coronavirus - HCoV-OC43, HCoV-HKU1, HCoV-229E, and HCoV-NL63. Participants will complete monthly questionnaires that ask about Coronavirus Disease 2019 (COVID-19) exposure risks, and a standardized, validated symptom questionnaire (scoring viral respiratory disease symptoms, intensity and severity) at least twice monthly and any day when any symptoms manifest. SARS-CoV-2 PCR testing will be performed any time participants develop symptoms consistent with COVID-19. For those individuals that seroconvert and/or test positive by SARS-CoV-2 PCR, or receive the SARS-CoV-2 vaccine, additional studies of T cell activation and cytokine production in response to SARS-CoV-2 peptide pools and analysis of Natural Killer cell numbers and function will be conducted on that participant’s cryopreserved baseline peripheral blood mononuclear cells (PBMCs). Following the first year of this study we will further analyze those participants having tested positive for COVID-19, and/or having received an authorized/licensed SARS-CoV-2 vaccine, quarterly (year 2) and semi-annually (years 3 and 4) to investigate immune response longevity.DiscussionThis study will determine the frequency of asymptomatic and pauci-symptomatic SARS-CoV-2 infection in a cohort of at-risk healthcare workers. Baseline and longitudinal assays will determine the frequency and magnitude of anti-spike glycoprotein antibodies to the seasonal HCoV-OC43, HCoV-HKU1, HCoV-229E, and HCoV-NL63, and may inform whether pre-existing antibodies to these human coronaviruses are associated with altered COVID-19 disease course. Finally, this study will evaluate whether pre-existing immune responses to seasonal HCoVs affect the magnitude and duration of antibody and T cell responses to SARS-CoV-2 vaccination, adjusting for demographic covariates.

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