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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.
BMC Infect Dis. 2021 Jun 09; 21(1):544.BI

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.

Authors+Show Affiliations

Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA. Belinda.Jackson.ctr@usuhs.edu. Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Belinda.Jackson.ctr@usuhs.edu.Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA. Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.Department of Preventive Medicine & Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, USA.Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA. General Dynamics Information Technology, Falls Church, VA, USA.Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA. General Dynamics Information Technology, Falls Church, VA, USA.Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA. General Dynamics Information Technology, Falls Church, VA, USA.Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA. General Dynamics Information Technology, Falls Church, VA, USA.Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA. Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA. Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA.Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.Infectious Disease Directorate, Naval Medical Research Center, Silver Spring, MD, USA.Clinical Trials Center, Naval Medical Research Center, Silver Spring, MD, USA.Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Bethesda, MD, USA. Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Department of Pediatrics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Basic Science Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.Department of Pharmacology and Molecular Therapeutics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Department of Anatomy, Physiology, and Genetics, and The American Genome Center, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Clinical Research Directorate, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA.Department of Microbiology and Immunology, Uniformed Services University of the Health Science, Bethesda, MD, USA. Edward.Mitre@usuhs.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34107889

Citation

Jackson-Thompson, Belinda M., et al. "Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) Study: an Observational Cohort Study of SARS-CoV-2 Infection and Vaccination in Healthcare Workers." BMC Infectious Diseases, vol. 21, no. 1, 2021, p. 544.
Jackson-Thompson BM, Goguet E, Laing ED, et al. Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) study: an observational cohort study of SARS-CoV-2 infection and vaccination in healthcare workers. BMC Infect Dis. 2021;21(1):544.
Jackson-Thompson, B. M., Goguet, E., Laing, E. D., Olsen, C. H., Pollett, S., Hollis-Perry, K. M., Maiolatesi, S. E., Illinik, L., Ramsey, K. F., Reyes, A. E., Alcorta, Y., Wong, M. A., Davies, J., Ortega, O., Parmelee, E., Lindrose, A. R., Moser, M., Graydon, E., Letizia, A. G., ... Mitre, E. (2021). Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) study: an observational cohort study of SARS-CoV-2 infection and vaccination in healthcare workers. BMC Infectious Diseases, 21(1), 544. https://doi.org/10.1186/s12879-021-06233-1
Jackson-Thompson BM, et al. Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) Study: an Observational Cohort Study of SARS-CoV-2 Infection and Vaccination in Healthcare Workers. BMC Infect Dis. 2021 Jun 9;21(1):544. PubMed PMID: 34107889.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) study: an observational cohort study of SARS-CoV-2 infection and vaccination in healthcare workers. AU - Jackson-Thompson,Belinda M, AU - Goguet,Emilie, AU - Laing,Eric D, AU - Olsen,Cara H, AU - Pollett,Simon, AU - Hollis-Perry,K Monique, AU - Maiolatesi,Santina E, AU - Illinik,Luca, AU - Ramsey,Kathleen F, AU - Reyes,Anatalio E, AU - Alcorta,Yolanda, AU - Wong,Mimi A, AU - Davies,Julian, AU - Ortega,Orlando, AU - Parmelee,Edward, AU - Lindrose,Alyssa R, AU - Moser,Matthew, AU - Graydon,Elizabeth, AU - Letizia,Andrew G, AU - Duplessis,Christopher A, AU - Ganesan,Anuradha, AU - Pratt,Kathleen P, AU - Malloy,Allison M, AU - Scott,David W, AU - Anderson,Stephen K, AU - Snow,Andrew L, AU - Dalgard,Clifton L, AU - Powers,John H,3rd AU - Tribble,David, AU - Burgess,Timothy H, AU - Broder,Christopher C, AU - Mitre,Edward, Y1 - 2021/06/09/ PY - 2021/02/17/received PY - 2021/05/24/accepted PY - 2021/6/10/entrez PY - 2021/6/11/pubmed PY - 2021/6/17/medline KW - COVID-19 KW - Coronavirus KW - Cross-reactivity KW - Immune-response KW - Prospective study KW - SARS-CoV-2 SP - 544 EP - 544 JF - BMC infectious diseases JO - BMC Infect Dis VL - 21 IS - 1 N2 - 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. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/34107889/Prospective_Assessment_of_SARS_CoV_2_Seroconversion__PASS__study:_an_observational_cohort_study_of_SARS_CoV_2_infection_and_vaccination_in_healthcare_workers_ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06233-1 DB - PRIME DP - Unbound Medicine ER -