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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.
Jackson-Thompson, Belinda M; Goguet, Emilie; Laing, Eric D; Olsen, Cara H; Pollett, Simon; Hollis-Perry, K Monique; Maiolatesi, Santina E; Illinik, Luca; Ramsey, Kathleen F; Reyes, Anatalio E; Alcorta, Yolanda; Wong, Mimi A; Davies, Julian; Ortega, Orlando; Parmelee, Edward; Lindrose, Alyssa R; Moser, Matthew; Graydon, Elizabeth; Letizia, Andrew G; Duplessis, Christopher A; Ganesan, Anuradha; Pratt, Kathleen P; Malloy, Allison M; Scott, David W; Anderson, Stephen K; Snow, Andrew L; Dalgard, Clifton L; Powers, John H; Tribble, David; Burgess, Timothy H; Broder, Christopher C; Mitre, Edward.
  • Jackson-Thompson BM; Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA. Belinda.Jackson.ctr@usuhs.edu.
  • Goguet E; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Belinda.Jackson.ctr@usuhs.edu.
  • Laing ED; Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.
  • Olsen CH; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Pollett S; Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.
  • Hollis-Perry KM; Department of Preventive Medicine & Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, USA.
  • Maiolatesi SE; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Illinik L; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
  • Ramsey KF; Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.
  • Reyes AE; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Alcorta Y; Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.
  • Wong MA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Davies J; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
  • Ortega O; Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.
  • Parmelee E; General Dynamics Information Technology, Falls Church, VA, USA.
  • Lindrose AR; Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.
  • Moser M; General Dynamics Information Technology, Falls Church, VA, USA.
  • Graydon E; Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.
  • Letizia AG; General Dynamics Information Technology, Falls Church, VA, USA.
  • Duplessis CA; Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.
  • Ganesan A; General Dynamics Information Technology, Falls Church, VA, USA.
  • Pratt KP; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Malloy AM; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
  • Scott DW; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Anderson SK; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
  • Snow AL; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
  • Dalgard CL; Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.
  • Powers JH; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Tribble D; Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.
  • Burgess TH; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.
  • Broder CC; Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.
  • Mitre E; Infectious Disease Directorate, Naval Medical Research Center, Silver Spring, MD, USA.
BMC Infect Dis ; 21(1): 544, 2021 Jun 09.
Article in English | MEDLINE | ID: covidwho-1262498
ABSTRACT

BACKGROUND:

SARS-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.

METHODS:

A 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.

DISCUSSION:

This 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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccination / Health Personnel / Seroconversion / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06233-1

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccination / Health Personnel / Seroconversion / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06233-1