Comparison of test-negative and syndrome-negative controls in SARS-CoV-2 vaccine effectiveness evaluations for preventing COVID-19 hospitalizations in the United States.

Autor:	Turbyfill C; CDC COVID-19 Emergency Response Team, Atlanta, GA, United States., Adams K; CDC COVID-19 Emergency Response Team, Atlanta, GA, United States. Electronic address: rqx6@cdc.gov., Tenforde MW; CDC COVID-19 Emergency Response Team, Atlanta, GA, United States., Murray NL; CDC COVID-19 Emergency Response Team, Atlanta, GA, United States., Gaglani M; Baylor Scott and White Health, Texas A&M University College of Medicine, Temple, TX, United States., Ginde AA; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, United States., McNeal T; Baylor Scott and White Health, Texas A&M University College of Medicine, Temple, TX, United States., Ghamande S; Baylor Scott and White Health, Texas A&M University College of Medicine, Temple, TX, United States., Douin DJ; Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO, United States., Keipp Talbot H; Departments of Medicine and Health Policy, Vanderbilt University Medical Center, Nashville, TN, United States., Casey JD; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States., Mohr NM; Department of Emergency Medicine, University of Iowa, Iowa City, IA, United States., Zepeski A; Department of Emergency Medicine, University of Iowa, Iowa City, IA, United States., Shapiro NI; Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA, United States., Gibbs KW; Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States., Clark Files D; Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States., Hager DN; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States., Shehu A; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States., Prekker ME; Department of Emergency Medicine and Medicine, Hennepin County Medical Center, Minneapolis, MN, United States., Frosch AE; Department of Medicine, Hennepin County Medical Center, Minneapolis, MN, United States., Exline MC; Department of Medicine, The Ohio State University, Columbus, OH, United States., Gong MN; Department of Medicine, Montefiore Health System, Albert Einstein College of Medicine, Bronx, NY, United States., Mohamed A; Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, United States., Johnson NJ; Department of Emergency Medicine and Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, WA, United States., Srinivasan V; Department of Emergency Medicine and Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, WA, United States., Steingrub JS; Department of Medicine, Baystate Medical Center, Springfield, MA, United States., Peltan ID; Department of Medicine, Intermountain Medical Center, Murray, Utah and University of Utah, Salt Lake City, UT, United States., Brown SM; Department of Medicine, Intermountain Medical Center, Murray, Utah and University of Utah, Salt Lake City, UT, United States., Martin ET; School of Public Health, University of Michigan, Ann Arbor, MI, United States., Lauring AS; Departments of Internal Medicine and Microbiology and Immunology, University of Michigan, Ann Arbor, MI, United States., Khan A; Department of Medicine, Oregon Health and Sciences University, Portland, OR, United States., Busse LW; Department of Medicine, Emory University, Atlanta, GA, United States., Ten Lohuis CC; Emory Critical Care Center, Emory Healthcare, Atlanta, GA, United States., Duggal A; Department of Medicine, Cleveland Clinic, Cleveland, OH, United States., Wilson JG; Department of Emergency Medicine, Stanford University School of Medicine, Stanford, CA, United States., June Gordon A; Department of Emergency Medicine, Stanford University School of Medicine, Stanford, CA, United States., Qadir N; Department of Medicine, University of California-Los Angeles, Los Angeles, CA, United States., Chang SY; Department of Medicine, University of California-Los Angeles, Los Angeles, CA, United States., Mallow C; Department of Medicine, University of Miami, Miami, FL, United States., Rivas C; Department of Medicine, University of Miami, Miami, FL, United States., Kwon JH; Department of Medicine, Washington University, St. Louis, MO, United States., Halasa N; Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, United States., Chappell JD; Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, United States., Grijalva CG; Department of Health Policy, Vanderbilt University Medical Center, Nashville, TN, United States., Rice TW; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States., Stubblefield WB; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, United States., Baughman A; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, United States., Rhoads JP; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, United States., Lindsell CJ; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, United States., Hart KW; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, United States., McMorrow M; CDC COVID-19 Emergency Response Team, Atlanta, GA, United States., Surie D; CDC COVID-19 Emergency Response Team, Atlanta, GA, United States., Self WH; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, United States; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, United States., Patel MM; CDC COVID-19 Emergency Response Team, Atlanta, GA, United States.
Jazyk:	angličtina
Zdroj:	Vaccine [Vaccine] 2022 Nov 15; Vol. 40 (48), pp. 6979-6986. Date of Electronic Publication: 2022 Oct 24.
DOI:	10.1016/j.vaccine.2022.10.034
Abstrakt:	Background: Test-negative design (TND) studies have produced validated estimates of vaccine effectiveness (VE) for influenza vaccine studies. However, syndrome-negative controls have been proposed for differentiating bias and true estimates in VE evaluations for COVID-19. To understand the use of alternative control groups, we compared characteristics and VE estimates of syndrome-negative and test-negative VE controls. Methods: Adults hospitalized at 21 medical centers in 18 states March 11-August 31, 2021 were eligible for analysis. Case patients had symptomatic acute respiratory infection (ARI) and tested positive for SARS-CoV-2. Control groups were test-negative patients with ARI but negative SARS-CoV-2 testing, and syndrome-negative controls were without ARI and negative SARS-CoV-2 testing. Chi square and Wilcoxon rank sum tests were used to detect differences in baseline characteristics. VE against COVID-19 hospitalization was calculated using logistic regression comparing adjusted odds of prior mRNA vaccination between cases hospitalized with COVID-19 and each control group. Results: 5811 adults (2726 cases, 1696 test-negative controls, and 1389 syndrome-negative controls) were included. Control groups differed across characteristics including age, race/ethnicity, employment, previous hospitalizations, medical conditions, and immunosuppression. However, control-group-specific VE estimates were very similar. Among immunocompetent patients aged 18-64 years, VE was 93 % (95 % CI: 90-94) using syndrome-negative controls and 91 % (95 % CI: 88-93) using test-negative controls. Conclusions: Despite demographic and clinical differences between control groups, the use of either control group produced similar VE estimates across age groups and immunosuppression status. These findings support the use of test-negative controls and increase confidence in COVID-19 VE estimates produced by test-negative design studies. Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors have completed and submitted the International Committee of Medical Journal Editors (ICMJE) disclosure form. Funding for this work was provided to all participating sites by the United States Centers for Disease Control and Prevention. Samuel Brown reports grants from National Institutes of Health (NIH) and Department of Defense (DoD), participation as the DSMB chair for Hamilton Ventilators, and participation as a member of the DSMB for New York University COVID clinical trials. Jonathan Casey reports funding from NIH and DoD. Steven Chang reports consulting fees from La Jolla Pharmaceuticals, PureTech Health, and Kiniska Pharmaceuticals, payment/honoraria from La Jolla Pharmaceuticals, and participation on a DSMB for an investigator-initiated study conducted at UCLA. James Chappell reports grants and other support from NIH. Abhijit Duggal reports consulting fees from ALung technologies. Matthew Exline reports payment/honorariua from Abbott Lab for sponsored talks. D. Clark Files reports consulting fees from Cytovale and participation on a DSMB for Medpace. Anne Frosch reports grants from NIH. Manjusha Gaglani reports grants from Centers for Disease Control and Prevention (CDC), CDC-Abt Associates, CDC-Westat, and Janssen, and a leadership role as co-chair of the Infectious Disease and Immunization Committee of the Texas Pediatric Society, Texas Chapter of American Academy of Pediatrics. Kevin Gibbs reports funding from NIH/ National Heart, Lung, and Blood Institute (NHLBI) for the ACTIV-4HT NECTAR trial. Nicholas Mohr reports grants from the CDC (funded 2 other multicenter COVID-related projects separate from this work through payments to author’s institution). Adit Ginde reports grants from NIH, DoD, AbbVie, and Faron Pharmaceuticals. Michelle Gong reports grants from NIH/NHLBI and Agency for Healthcare Research and Quality (AHRQ), consulting fees from Endpoint, a leadership role on the American Thoracic Society (ATS) executive committee and board as well as support from ATS for meeting travel expenses, and participation on a DSMB for Regeneron. Carlos Grijalva reports grants from NIH, CDC, Food and Drug Administration (FDA), AHRQ, Sanofi, and Syneos Health and consulting fees from Pfizer, Merck, and Sanofi. David Hager reports grants from NIH/NHLBI for the ACTIV-4HT NECTAR trial and Incyte Corporation and participation as a DSMB chair for the SAFE EVICT Trial of vitamin C in COVID-19. Jennifer Wilson reports grants from the CDC and NIH (ARREST Pneumonia Trial UH3HL141722, ACTIV3a and 3b trials, and ACTIV4a trial), and membership on the American Board of Internal Medicine Critical Care Medicine exam committee. Natasha Halasa reports grants from NIH, Quidel, and Sanofi and honoraria for speaking at the American Academy of Pediatrics (AAP) conference. Nicholas Johnson reports grants from NIH/NHLBI/NINDS and the University of Washington Royalty Research Fund and payment for expert testimony for the Washington Department of Health. Akram Khan reports grants from United Therapeutics, Gilead Sciences, and 4D Medical and a leadership role on the guidelines committee for Chest. Jennie Kwon reports grants from NIH/NIAID. Adam Lauring reports grants from CDC, NIH/NIAID, and Burroughs Wellcome Fund and consulting fees from Sanofi and Roche. Christopher Lindsell reports grants from NIH, DoD, CDC, bioMerieux, Entegrion Inc., Endpoint Health, and AbbVie, patents for risk stratification in sepsis and septic shock, participation on DSMBs for clinical trials unrelated to the current work, a leadership role on the executive committee for the Board of Directors of the Association for Clinical and Translational Science, and stock options in Bioscape Digita. Emily Martin reports grants from Merck, CDC, and NIH and payment/honoraria from the Michigan Infectious Disease Society. Tresa McNeal reports payment/honoraria from the Society of Hospital Medicine. Ithan Peltan reports grants from NIH, Janssen, Regeneron, and Asahi Kasei Pharma. Todd Rice reports grants from AbbVie Inc., consulting fees from Cumberland Pharmaceuticals, Inc. and Cytovale, Inc., membership on a DSMB for Sanofi, Inc., a leadership role as immediate past president of the American Society of Parenteral and Enteral Nutrition, and stock options in Cumberland Pharmaceuticals, Inc. Wesley Self reports receiving the primary funding for this project from the United States Centers for Disease Control and Prevention, and research funding from Merck and Gilead Sciences. William Stubblefield reports grants from the NIH/NHLBI. (Published by Elsevier Ltd.)
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