PMID- 37640860
OWN - NLM
STAT- MEDLINE
DCOM- 20230918
LR  - 20240228
IS  - 1546-170X (Electronic)
IS  - 1078-8956 (Print)
IS  - 1078-8956 (Linking)
VI  - 29
IP  - 9
DP  - 2023 Sep
TI  - Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 
      randomized open-label COVAIL trial.
PG  - 2334-2346
LID - 10.1038/s41591-023-02503-4 [doi]
AB  - Vaccine protection against severe acute respiratory syndrome coronavirus 2 
      (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, 
      open-label, randomized clinical trial with sequentially enrolled stages at 22 US 
      sites, we assessed safety and immunogenicity of a second boost with monovalent or 
      bivalent variant vaccines from mRNA and protein-based platforms targeting 
      wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was 
      pseudovirus neutralization titers at 50% inhibitory dilution (ID(50) titers) with 
      95% confidence intervals against different SARS-CoV-2 strains. The secondary 
      outcome assessed safety by solicited local and systemic adverse events (AEs), 
      unsolicited AEs, serious AEs and AEs of special interest. Boosting with 
      prototype/wild-type vaccines produced numerically lower ID(50) titers than any 
      variant-containing vaccine against all variants. Conversely, boosting with a 
      variant vaccine excluding prototype was not associated with decreased 
      neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were 
      nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent 
      vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although 
      they were lower for contemporaneous Omicron subvariants. Safety was similar 
      across arms and stages and comparable to previous reports. Our study shows that 
      updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective 
      neutralizing antibody responses against diverse SARS-CoV-2 variants without 
      sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: 
      NCT05289037 .
CI  - (c) 2023. The Author(s).
FAU - Branche, Angela R
AU  - Branche AR
AUID- ORCID: 0000-0002-7742-5352
AD  - Department of Medicine, Division of Infectious Diseases, University of Rochester, 
      Rochester, NY, USA. angela_branche@urmc.rochester.edu.
FAU - Rouphael, Nadine G
AU  - Rouphael NG
AD  - Hope Clinic, Emory University, Decatur, GA, USA.
FAU - Diemert, David J
AU  - Diemert DJ
AUID- ORCID: 0000-0002-2789-0512
AD  - George Washington Vaccine Research Unit, George Washington University, Washington 
      D.C., WA, USA.
FAU - Falsey, Ann R
AU  - Falsey AR
AD  - Department of Medicine, Division of Infectious Diseases, University of Rochester, 
      Rochester, NY, USA.
FAU - Losada, Cecilia
AU  - Losada C
AD  - Hope Clinic, Emory University, Decatur, GA, USA.
FAU - Baden, Lindsey R
AU  - Baden LR
AD  - Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
FAU - Frey, Sharon E
AU  - Frey SE
AD  - Center for Vaccine Development, Saint Louis University, St. Louis, MO, USA.
FAU - Whitaker, Jennifer A
AU  - Whitaker JA
AD  - Departments of Molecular Virology and Microbiology and Medicine, Baylor College 
      of Medicine, Houston, TX, USA.
FAU - Little, Susan J
AU  - Little SJ
AUID- ORCID: 0000-0002-7645-9737
AD  - Division of Infectious Diseases and Global Public Health, Department of Medicine, 
      University of California San Diego, La Jolla, CA, USA.
FAU - Anderson, Evan J
AU  - Anderson EJ
AUID- ORCID: 0000-0002-1576-4420
AD  - Center for Childhood Infections and Vaccines (CCIV) of Children's Healthcare of 
      Atlanta and Emory University Department of Pediatrics, Atlanta, GA, USA.
FAU - Walter, Emmanuel B
AU  - Walter EB
AD  - Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, 
      USA.
FAU - Novak, Richard M
AU  - Novak RM
AD  - Project WISH, University of Illinois at Chicago, Chicago, IL, USA.
FAU - Rupp, Richard
AU  - Rupp R
AD  - University of Texas Medical Branch, Galveston, TX, USA.
FAU - Jackson, Lisa A
AU  - Jackson LA
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
FAU - Babu, Tara M
AU  - Babu TM
AD  - Departments of Medicine, Epidemiology and Laboratory Medicine and Pathology, 
      University of Washington, Vaccines and Infectious Diseases Division, Fred 
      Hutchinson Cancer Center, Seattle, WA, USA.
FAU - Kottkamp, Angelica C
AU  - Kottkamp AC
AUID- ORCID: 0000-0003-4103-1666
AD  - NYU VTEU Manhattan Research Clinic, NYU Grossman School of Medicine, New York, 
      NY, USA.
FAU - Luetkemeyer, Anne F
AU  - Luetkemeyer AF
AUID- ORCID: 0000-0003-0911-1578
AD  - Zuckerberg San Francisco General, University of California San Francisco, San 
      Francisco, CA, USA.
FAU - Immergluck, Lilly C
AU  - Immergluck LC
AD  - Department of Microbiology, Biochemistry and Immunology, and Clinical Research 
      Center, Morehouse School of Medicine, Atlanta, GA, USA.
FAU - Presti, Rachel M
AU  - Presti RM
AUID- ORCID: 0000-0002-5469-0727
AD  - Washington University School of Medicine, St. Louis, MO, USA.
FAU - Backer, Martin
AU  - Backer M
AD  - NYU VTEU Long Island Research Clinic, NYU Long Island School of Medicine, 
      Mineola, NY, USA.
FAU - Winokur, Patricia L
AU  - Winokur PL
AD  - College of Medicine, University of Iowa, Iowa City, IA, USA.
FAU - Mahgoub, Siham M
AU  - Mahgoub SM
AD  - Howard University College of Medicine, Howard University Hospital, Washington 
      D.C., WA, USA.
FAU - Goepfert, Paul A
AU  - Goepfert PA
AD  - Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
FAU - Fusco, Dahlene N
AU  - Fusco DN
AUID- ORCID: 0000-0002-5629-0110
AD  - Tulane University School of Medicine, New Orleans, LA, USA.
FAU - Malkin, Elissa
AU  - Malkin E
AUID- ORCID: 0000-0003-0943-5433
AD  - George Washington Vaccine Research Unit, George Washington University, Washington 
      D.C., WA, USA.
FAU - Bethony, Jeffrey M
AU  - Bethony JM
AD  - George Washington Vaccine Research Unit, George Washington University, Washington 
      D.C., WA, USA.
FAU - Walsh, Edward E
AU  - Walsh EE
AD  - Department of Medicine, Division of Infectious Diseases, University of Rochester, 
      Rochester, NY, USA.
FAU - Graciaa, Daniel S
AU  - Graciaa DS
AUID- ORCID: 0000-0002-9484-8488
AD  - Hope Clinic, Emory University, Decatur, GA, USA.
FAU - Samaha, Hady
AU  - Samaha H
AUID- ORCID: 0000-0002-9124-7820
AD  - Hope Clinic, Emory University, Decatur, GA, USA.
FAU - Sherman, Amy C
AU  - Sherman AC
AUID- ORCID: 0000-0002-6075-3990
AD  - Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
FAU - Walsh, Stephen R
AU  - Walsh SR
AUID- ORCID: 0000-0002-0817-9370
AD  - Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
FAU - Abate, Getahun
AU  - Abate G
AD  - Center for Vaccine Development, Saint Louis University, St. Louis, MO, USA.
FAU - Oikonomopoulou, Zacharoula
AU  - Oikonomopoulou Z
AD  - Center for Vaccine Development, Saint Louis University, St. Louis, MO, USA.
FAU - El Sahly, Hana M
AU  - El Sahly HM
AD  - Departments of Molecular Virology and Microbiology and Medicine, Baylor College 
      of Medicine, Houston, TX, USA.
FAU - Martin, Thomas C S
AU  - Martin TCS
AD  - Division of Infectious Diseases and Global Public Health, Department of Medicine, 
      University of California San Diego, La Jolla, CA, USA.
FAU - Kamidani, Satoshi
AU  - Kamidani S
AUID- ORCID: 0000-0001-6829-0700
AD  - Center for Childhood Infections and Vaccines (CCIV) of Children's Healthcare of 
      Atlanta and Emory University Department of Pediatrics, Atlanta, GA, USA.
FAU - Smith, Michael J
AU  - Smith MJ
AD  - Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, 
      USA.
FAU - Ladner, Benjamin G
AU  - Ladner BG
AD  - Project WISH, University of Illinois at Chicago, Chicago, IL, USA.
FAU - Porterfield, Laura
AU  - Porterfield L
AUID- ORCID: 0000-0001-9144-144X
AD  - University of Texas Medical Branch, Galveston, TX, USA.
FAU - Dunstan, Maya
AU  - Dunstan M
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
FAU - Wald, Anna
AU  - Wald A
AD  - Departments of Medicine, Epidemiology and Laboratory Medicine and Pathology, 
      University of Washington, Vaccines and Infectious Diseases Division, Fred 
      Hutchinson Cancer Center, Seattle, WA, USA.
FAU - Davis, Tamia
AU  - Davis T
AD  - NYU VTEU Manhattan Research Clinic, NYU Grossman School of Medicine, New York, 
      NY, USA.
FAU - Atmar, Robert L
AU  - Atmar RL
AUID- ORCID: 0000-0001-9989-6772
AD  - Departments of Molecular Virology and Microbiology and Medicine, Baylor College 
      of Medicine, Houston, TX, USA.
FAU - Mulligan, Mark J
AU  - Mulligan MJ
AD  - NYU VTEU Manhattan Research Clinic, NYU Grossman School of Medicine, New York, 
      NY, USA.
FAU - Lyke, Kirsten E
AU  - Lyke KE
AUID- ORCID: 0000-0002-4966-0830
AD  - Center for Vaccine Development and Global Health, University of Maryland School 
      of Medicine Baltimore, Baltimore, MD, USA.
FAU - Posavad, Christine M
AU  - Posavad CM
AD  - IDCRC Laboratory Operations Unit, Fred Hutchinson Cancer Center, Seattle, WA, 
      USA.
FAU - Meagher, Megan A
AU  - Meagher MA
AUID- ORCID: 0009-0009-6915-4861
AD  - IDCRC Laboratory Operations Unit, Fred Hutchinson Cancer Center, Seattle, WA, 
      USA.
FAU - Stephens, David S
AU  - Stephens DS
AD  - Department of Medicine and Woodruff Health Sciences Center, Emory University, 
      Atlanta, GA, USA.
FAU - Neuzil, Kathleen M
AU  - Neuzil KM
AUID- ORCID: 0000-0001-9480-2714
AD  - Center for Vaccine Development and Global Health, University of Maryland School 
      of Medicine Baltimore, Baltimore, MD, USA.
FAU - Abebe, Kuleni
AU  - Abebe K
AD  - FHI 360, Durham, NC, USA.
FAU - Hill, Heather
AU  - Hill H
AD  - Department of Surgery, Duke University Medical Center, Durham, NC, USA.
FAU - Albert, Jim
AU  - Albert J
AD  - The Emmes Company, LLC, Rockville, MD, USA.
FAU - Telu, Kalyani
AU  - Telu K
AD  - The Emmes Company, LLC, Rockville, MD, USA.
FAU - Mu, Jinjian
AU  - Mu J
AUID- ORCID: 0000-0002-3270-6775
AD  - The Emmes Company, LLC, Rockville, MD, USA.
FAU - Lewis, Teri C
AU  - Lewis TC
AD  - Clinical Monitoring Research Program Directorate, Frederick National Laboratory 
      for Cancer Research, Frederick, MD, USA.
FAU - Giebeig, Lisa A
AU  - Giebeig LA
AD  - Clinical Monitoring Research Program Directorate, Frederick National Laboratory 
      for Cancer Research, Frederick, MD, USA.
FAU - Eaton, Amanda
AU  - Eaton A
AUID- ORCID: 0000-0003-3064-2947
AD  - Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, 
      USA.
AD  - Department of Surgery, Duke University Medical Center, Durham, NC, USA.
FAU - Netzl, Antonia
AU  - Netzl A
AUID- ORCID: 0000-0001-8034-2382
AD  - Center for Pathogen Evolution, Department of Zoology, University of Cambridge, 
      Cambridge, UK.
FAU - Wilks, Samuel H
AU  - Wilks SH
AUID- ORCID: 0000-0002-7760-8474
AD  - Center for Pathogen Evolution, Department of Zoology, University of Cambridge, 
      Cambridge, UK.
FAU - Tureli, Sina
AU  - Tureli S
AD  - Center for Pathogen Evolution, Department of Zoology, University of Cambridge, 
      Cambridge, UK.
FAU - Makhene, Mamodikoe
AU  - Makhene M
AD  - Division of Microbiology and Infectious Diseases, National Institute of Allergy 
      and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
FAU - Crandon, Sonja
AU  - Crandon S
AD  - Division of Microbiology and Infectious Diseases, National Institute of Allergy 
      and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
FAU - Montefiori, David C
AU  - Montefiori DC
AD  - Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, 
      USA.
AD  - Department of Surgery, Duke University Medical Center, Durham, NC, USA.
FAU - Makowski, Mat
AU  - Makowski M
AD  - The Emmes Company, LLC, Rockville, MD, USA.
FAU - Smith, Derek J
AU  - Smith DJ
AD  - Center for Pathogen Evolution, Department of Zoology, University of Cambridge, 
      Cambridge, UK.
FAU - Nayak, Seema U
AU  - Nayak SU
AD  - Division of Microbiology and Infectious Diseases, National Institute of Allergy 
      and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
FAU - Roberts, Paul C
AU  - Roberts PC
AUID- ORCID: 0000-0002-4452-141X
AD  - Division of Microbiology and Infectious Diseases, National Institute of Allergy 
      and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
FAU - Beigel, John H
AU  - Beigel JH
AUID- ORCID: 0000-0002-4879-4941
AD  - Division of Microbiology and Infectious Diseases, National Institute of Allergy 
      and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
CN  - COVAIL Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT05289037
GR  - UM1 AI148450/AI/NIAID NIH HHS/United States
GR  - 75N91019D00024/CA/NCI NIH HHS/United States
GR  - 75N93021D00021/AI/NIAID NIH HHS/United States
GR  - 75N93021C00012/AI/NIAID NIH HHS/United States
GR  - C0000008/CL/CLC NIH HHS/United States
GR  - UM1 AI148684/AI/NIAID NIH HHS/United States
GR  - 75N93021C00014/AI/NIAID NIH HHS/United States
GR  - 75N93019C00050/AI/NIAID NIH HHS/United States
GR  - UM1 AI148574/AI/NIAID NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20230828
PL  - United States
TA  - Nat Med
JT  - Nature medicine
JID - 9502015
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Broadly Neutralizing Antibodies)
RN  - SARS-CoV-2 variants
SB  - IM
UOF - Res Sq. 2023 May 05;:. PMID: 37205592
MH  - Humans
MH  - *COVID-19 Vaccines/adverse effects
MH  - SARS-CoV-2/genetics
MH  - *COVID-19/prevention & control
MH  - Broadly Neutralizing Antibodies
PMC - PMC10504073
COIS- L.G. has received funding from Leidos Biomedical Research. E.J.A. has received 
      funding from Pfizer, Moderna, Janssen, GSK, Sanofi Pasteur, Micron and Regeneron 
      (payment made to institution); and serves a safety monitoring role for Sanofi 
      Pasteur, ACI Clinical/WCG and Kentucky Bioscience (payment made to E.J.A.). J.A. 
      has received funding from the Division of Microbiology and Infectious Diseases, 
      contract no. 75N93021C00012. A.R.B. has received grant funding from NIH, NIAID, 
      Pfizer, Cyanvac and Merck (payment to institution); and has received consulting 
      fees from Janssen and GSK (payment made to A.R.B.). L.R.B. has received grant 
      funding from NIH, NIH/Harvard Medical School, Wellcome Trust and the Gates 
      Foundation; and serves in a data safety monitoring role for NIH, US Food and Drug 
      Administration (payment made to institution). She is involved in HIV and 
      SARS-CoV-2 vaccine clinical trials conducted in collaboration with the NIH, HIV 
      Vaccine Trials Network, COVID Vaccine Prevention Network, International AIDS 
      Vaccine Initiative, Crucell/Janssen, Moderna, Military HIV Research Program, the 
      Gates Foundation and Harvard Medical School. D.J.D. has received funding from 
      Leidos Biomedical (research contract to his institution) to conduct a clinical 
      trial. A.E. has received DMID funding via NIH subcontract to Duke University for 
      the CIVICS Option 21 and Moderna. H.M.E.S. has received funding support from the 
      NIH (grant no. 22CTA-DM0002). A.R.F. has received grant funding from Janssen, 
      Pfizer, Merck, BioFire Diagnostics and CyanVac (payment made to institution); and 
      has received consultant fees from Arrowhead, Icosavax, Moderna and 
      GlaxoSmithKline (payable to A.R.F.). A.R.F. also reports travel meeting support 
      from GlaxoSmithKline, and serving in a data safety monitoring role for Novavax. 
      S.E.F. has received funding from Leidos to Saint Louis University to conduct the 
      protocol, DMID22-0004. D.N.F. has received a contract from the CDC and is the 
      site PI for clinical trials from Gilead, Regeneron and MetroBiothech. She is the 
      PI on one investigator-initiated award from Gilead and served on an advisory 
      board for Gilead in 2021. P.A.G. has received COVAIL clinical trial funding and 
      consulting fees from Janssen Vaccines (payment made to P.A.G.). D.S.G. has 
      received funding from NIAID/IDCRC, Henry M. Jackson Foundation Contract, and 
      consulting fees from Critica (payment to a nonprofit organization). H.H. has 
      received funding support from the Division of Microbiology and Infectious 
      Diseases, contract no. 75N93021C00012. L.C.I. has received funding from 
      NIH/NIAID/DMID, Moderna and Pfizer (payment made to Sanofi); grant support from 
      GSK, Merck, Sharpe & Dohme and CDC (payment made to institution); consulting fees 
      from Moderna Scientific Advisory Board, CDC, Pediatric Emergency Medicine 
      Associates, American Academy of Pediatrics, Rockefeller University and American 
      Academy of Pediatrics-Georgia Chapter; and travel support from American Academy 
      of Pediatrics and Moderna. L.C.I. serves as in a data safety monitoring role for 
      NIH-Phase 2 Vaccine Trial for Monkeypox, Moderna Scientific Advisory Board North 
      America, COVID-19 Task Force, Georgia, Pediatric Infectious Disease Society, 
      Emory University-Pediatric and Reproductive Environmental Health 
      Scholars-Southeastern (board member), Center for Spatial Analytics, Georgia 
      Institute of Technology (board member) and American Academy of Pediatrics 
      (executive board for section on infectious diseases). L.A.J. has received funding 
      from Pfizer to support a clinical trial, contract funding for research support 
      from the CDC (to institution). Financial support for study was provided to 
      L.A.J.'s institution by the NIH. L.A.J. also reports unpaid participation for 
      service on data safety monitoring boards for NIH-funded clinical trials. S.K. has 
      received funding from the NIH to conduct the COVAIL clinical trial of COVID-19 
      vaccines, Moderna and Janssen for COVID-19 vaccines, Pfizer to conduct clinical 
      trials of Pfizer-BioNTech COVID-19 vaccines, and CDC to conduct surveillance for 
      COVID-19 VE. Payments were made to Emory University. B.G.L. has received gifts 
      from Gilead Dinner at CROI 2023. S.J.L. has received funding from NIH grants, 
      payment made to institution. A.F.L. has received funding from Merck, Gilead and 
      Viiv (payment to UCSF); consulting fees from Vir Biotechnology; travel support 
      from Merck to attend a required investigator meeting; and testing kits and 
      supplies to support research study from Hologic. K.E.L. has received funding from 
      Pfizer-BioNTech for trial operations. M. Matkowski has received funding from the 
      Division of Microbiology and Infectious Diseases, contract no. 75N93021C00012. 
      T.C.S.M. has received funding from Gilead Sciences as coinvestigator and travel 
      support for conference attendance from Gilead. M.A.M. has received funding from 
      NIAID UM1AI148684. D.C.M. has received funding from NIH 75N93019C00050-21A: 
      CIVICS A- Option 21A-DMID Trials of COVID-19 Vaccines. J.M. has received funding 
      from the Division of Microbiology and Infectious Diseases contract no. 
      75N93021C00012. A.N. has received funding or grant support from NIH-NIAID and 
      CEIRR, Gates Cambridge Trust and NIH-NIAID R01. K.M.N. has received grants 
      support from the NIH to participate in the overall organization of COVID-19 
      trials and for participation in vaccines trials, Center for Vaccine Development 
      and Global Health and Pfizer to conduct clinical trials of COVID-19 vaccines 
      without salary support. R.M.N. has received funding from Moderna and Janssen, and 
      travel support from Moderna. Z.O. has received funding from Leidos subcontract 
      agreement no. 22CTA-DM0006 (for role as subinvestigator; clinical trial conduct, 
      manuscript review). Payments were made to Saint Louis University. C.M.P. has 
      received funding from NIAID UM1AI148684. R.M.P. has received funding from NIH, 
      DMID, COVAIL, Janssen and Moderna. N.G.R. has received research grants from 
      Pfizer, Merck, Sanofi, Quidel and Lilly. Her institution has also received 
      funding from NIH to conduct clinical trials. N.G.R. serves on safety committees 
      for ICON and EMMES and is on the advisory boards of Moderna and Sanofi. D.J.S. 
      has received funding from NIH-NIAID CEIRR (NIH-NIAID R01). N.G.R. reports 
      travel-related meetings from NIH-NIAID CEIRR. D.S.S. has received a funding grant 
      from the NIH IDCRC. M.J.S. has received grant support from Pfizer (through 
      institution) as a research contract for COVID-19 vaccine and therapy clinical 
      trials, expert consulting fees from Garau Germano Medicolegal (paid to M.J.S.). 
      M.J.S. reports serving as chair of the Section on Epidemiology, Public Health and 
      Evidence (volunteer position) for American Academy of Pediatrics. K.T. has 
      received funding from the Division of Microbiology and Infectious Diseases, 
      contract no. 75N93021C00012. S.T. has received NIH-NIAID R01, CEIRR. A.W. has 
      received funding from NIH, Sanofi and GSK (payments made to institution), and 
      consulting fees from Aicuris, Crozet Auritec and DxNow. A.W. reports serving in a 
      data safety monitoring role for Merck X-Vax, Vir and Curevo, and receiving other 
      financial interest from Merck for a vaccine clinical trial. E.E.W. has received 
      grant funding from NIH-DMID, Pfizer and Merck (with payment made to the 
      institution), and consulting fees from Merck (payment made to E.E.W.). E.B.W. has 
      received funding from Leidos Biomedical Research (agreement no. 22CTA-DM0009), 
      Pfizer, Moderna, Sequiris, Clinetic and Najit Technologies (PI for vaccine 
      study), with payments made to institution; and honoraria as a speaker from 
      College of Diplomates of the American Board of Pediatric Dentistry (payment made 
      to E.B.W.). He received travel support from the American Academy of Pediatrics 
      and consulting fees from Iliad Biotechnologies. He reports serving as an advisory 
      board member for Vaxcyte Scientific (payment made to E.B.W.). S.R.W. has received 
      funding from NIH, Pfizer, Sanofi Pasteur, Janssen Vaccines/Johnson & Johnson, 
      Moderna Tx, Vir Biotechnology and Worcester HIV Vaccine; and travel support from 
      Sanofi Pasteur, with payments made to institution. S.R.W. serves in a data safety 
      monitoring role and on an advisory board for Janssen Vaccines/Johnson & Johnson. 
      S.R.W.'s spouse is an employee of Regeneron Pharmaceuticals and holds stock/stock 
      options. P.L.W. has received subcontract funding from NIH, grant funding from 
      NIH, contract funding from Pfizer to University of Iowa. P.L.W. serves in a data 
      safety monitoring role and is an advisory board member for Emmes Corporation. The 
      other authors declare no competing interests.
FIR - Walsh, Edward
IR  - Walsh E
FIR - Kingsley, Patrick
IR  - Kingsley P
FIR - Steinmetz, Kari
IR  - Steinmetz K
FIR - Peasley, Michael
IR  - Peasley M
FIR - Ackerley, Cassie Grimsley
IR  - Ackerley CG
FIR - Unterberger, Kristen E
IR  - Unterberger KE
FIR - Desrosiers, Aimee
IR  - Desrosiers A
FIR - Siegel, Marc
IR  - Siegel M
FIR - Tong, Alexandra
IR  - Tong A
FIR - Rooks, Rebecca
IR  - Rooks R
FIR - Hoft, Daniel F
IR  - Hoft DF
FIR - Graham, Irene
IR  - Graham I
FIR - Keitel, Wendy A
IR  - Keitel WA
FIR - Healy, C Mary
IR  - Healy CM
FIR - Carter, Nicole
IR  - Carter N
FIR - Hendrickx, Steven
IR  - Hendrickx S
FIR - Rostad, Christina A
IR  - Rostad CA
FIR - Peters, Etza
IR  - Peters E
FIR - Nolan, Lauren
IR  - Nolan L
FIR - Moody, M Anthony
IR  - Moody MA
FIR - Schmader, Kenneth E
IR  - Schmader KE
FIR - Wendrow, Andrea
IR  - Wendrow A
FIR - Herrick, Jessica
IR  - Herrick J
FIR - Lau, Rebecca
IR  - Lau R
FIR - Carste, Barbara
IR  - Carste B
FIR - Krause, Taylor
IR  - Krause T
FIR - Hauge, Kirsten
IR  - Hauge K
FIR - Engelson, Celia
IR  - Engelson C
FIR - Soma, Vijaya
IR  - Soma V
FIR - Harris, Chloe
IR  - Harris C
FIR - Lopez, Azquena Munoz
IR  - Lopez AM
FIR - Johnson, Erica
IR  - Johnson E
FIR - Chan, Austin
IR  - Chan A
FIR - Ali, Fatima
IR  - Ali F
FIR - Parker, Trisha
IR  - Parker T
FIR - O'Halloran, Jane A
IR  - O'Halloran JA
FIR - Thompson, Ryley M
IR  - Thompson RM
FIR - Byrnes, Kimberly
IR  - Byrnes K
FIR - Noor, Asif
IR  - Noor A
FIR - Meier, Jeffery
IR  - Meier J
FIR - Stapleton, Jack
IR  - Stapleton J
FIR - Maxwell, Celia
IR  - Maxwell C
FIR - Shami, Sarah
IR  - Shami S
FIR - Drouin, Arnaud C
IR  - Drouin AC
FIR - Numbi, Florice K
IR  - Numbi FK
FIR - McElrath, Julie
IR  - McElrath J
FIR - Gale, Mike
IR  - Gale M
FIR - Baughman, Holly
IR  - Baughman H
FIR - McQuarrie, Lisa
IR  - McQuarrie L
FIR - Engel, Theresa M
IR  - Engel TM
FIR - Griffith, Caleb J
IR  - Griffith CJ
FIR - McDonald, Wendi L
IR  - McDonald WL
FIR - Burkey, Alissa E
IR  - Burkey AE
FIR - Hoopengardner, Lisa B
IR  - Hoopengardner LB
FIR - Linton, Jessica E
IR  - Linton JE
FIR - Gettinger, Nikki L
IR  - Gettinger NL
FIR - Lee, Marina
IR  - Lee M
FIR - Elsafy, Mohamed
IR  - Elsafy M
FIR - Pikaart-Tautges, Rhonda
IR  - Pikaart-Tautges R
FIR - Arega, Janice
IR  - Arega J
FIR - Hoang, Binh
IR  - Hoang B
FIR - Dan Curtin
IR  - Dan Curtin
FIR - Koo, Hyung
IR  - Koo H
FIR - Sindall, Elisa
IR  - Sindall E
FIR - DeGrace, Marciela M
IR  - DeGrace MM
FIR - Post, Diane J
IR  - Post DJ
FIR - Stephens, David S
IR  - Stephens DS
FIR - Neuzil, Kathleen M
IR  - Neuzil KM
FIR - Farley, Monica M
IR  - Farley MM
FIR - Marrazzo, Jeanne
IR  - Marrazzo J
FIR - Young, Sidnee Paschal
IR  - Young SP
FIR - Lennox, Jeffery
IR  - Lennox J
FIR - Atmar, Robert L
IR  - Atmar RL
FIR - McNeil, Linda
IR  - McNeil L
FIR - Brown, Elizabeth
IR  - Brown E
EDAT- 2023/08/29 00:42
MHDA- 2023/09/18 12:43
PMCR- 2023/08/28
CRDT- 2023/08/28 23:28
PHST- 2023/03/03 00:00 [received]
PHST- 2023/07/17 00:00 [accepted]
PHST- 2023/09/18 12:43 [medline]
PHST- 2023/08/29 00:42 [pubmed]
PHST- 2023/08/28 23:28 [entrez]
PHST- 2023/08/28 00:00 [pmc-release]
AID - 10.1038/s41591-023-02503-4 [pii]
AID - 2503 [pii]
AID - 10.1038/s41591-023-02503-4 [doi]
PST - ppublish
SO  - Nat Med. 2023 Sep;29(9):2334-2346. doi: 10.1038/s41591-023-02503-4. Epub 2023 Aug 
      28.