Accepted for Publication: January 21, 2022.
Published Online: February 7, 2022. doi:10.1001/jama.2022.1206
Corresponding Author: Andrea G. Edlow, MD, MSc, Department of Obstetrics & Gynecology, Massachusetts General Hospital, 55 Fruit St, Their Bldg, Floor 9, Boston, MA 02114 (aedlow@mgh.harvard.edu).
Author Contributions: Drs Alter and Edlow had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr Shook and Ms Atyeo contributed equally to this work. Drs Alter and Edlow contributed equally to this work.
Concept and design: Yonker, Fasano, Alter, Edlow.
Acquisition, analysis, or interpretation of data: Shook, Atyeo, Yonker, Gray, Alter, Edlow.
Drafting of the manuscript: Shook, Atyeo, Yonker, Alter, Edlow.
Critical revision of the manuscript for important intellectual content: Shook, Atyeo, Yonker, Fasano, Gray, Alter.
Statistical analysis: Shook, Atyeo, Alter, Edlow.
Obtained funding: Fasano, Alter, Edlow.
Administrative, technical, or material support: Yonker, Gray, Alter, Edlow.
Supervision: Yonker, Fasano, Gray, Alter, Edlow.
Conflict of Interest Disclosures: Dr Fasano reported being a cofounder and stockholder of Alba Therapeutics; serving on the scientific advisory board of Viome; and receiving personal fees from Milky Way and Mead Johnson Nutrition. Dr Gray reported receiving nonfinancial support from Illumina, Aetion, and BillionToOne. Dr Alter reported being the founder of and consultant to Systems Seromyx; receiving grants from Sanofi, GlaxoSmithKline, BioNTech, and Medicago; and being a consultant to Leyden Labs. No other disclosures were reported.
Funding/Support: This study was supported by grants 1R01HD100022-01 and 3R01HD100022-02S2 (Dr Edlow) and 1K12HD103096 (Dr Shook) from the National Institute of Child Health and Human Development; grant 6-FY20-223 from the March of Dimes (Dr Edlow); grants K08HL1469630-03 and 3K08HL146963-02S1 (Dr Gray) and 5K08HL143183 (Dr Yonker) from the National Heart, Lung, and Blood Institute; the Ragon Institute of MGH, MIT, and Harvard and the MGH ECOR Scholars award (Dr Alter); the Nancy Zimmerman, Samana Kay MGH Research Scholars award (Dr Alter); grants 3R37AI080289-11S1, R01AI146785, U19AI42790-01, U19AI135995-02, 1U01CA260476-01, and CIVIC5N93019C00052 from the National Institute of Allergy and Infectious Diseases (Dr Alter); and grants OPP1146996 and INV-001650 from the Gates Foundation Global Health Vaccine Accelerator Platform (Dr Alter). The TAPII blood collection devices for infant blood draw were provided at reduced cost by YourBio Health.
Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Madeleine Burns, BS, MS, of the Massachusetts General Hospital Department of Pediatrics, for her contributions to participant recruitment and sample collection. She was not compensated for this work beyond her salary as a clinical research coordinator.
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