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Article History

Received: 23 April 2025

Accepted: 8 December 2025

First Online: 16 January 2026

Declarations

:

: Andrew Ustianowski reports honoraria/speaker fees from AstraZeneca, Sanofi, Merck, Janssen, GSK, and Gilead; and advisory boards for Gilead, Merck, Pfizer, and ViiV Healthcare/GSK. Myron J. Levin reports advisory boards for GSK, Pfizer, Curevo, Moderna, Seqirus, and Dynavax; and research funds from GSK. Stephane De Wit reports honoraria/speaker fees from AstraZeneca, Sanofi, Merck, Janssen, GSK, and Gilead, and advisory boards for Gilead, Merck, Pfizer, and ViiV Healthcare/GSK. Odile Launay received honoraria/speaker fees for advisory boards or lectures from AstraZeneca, Sanofi, Pfizer, Merck, and GSK; and was principal investigator for the AstraZeneca-sponsored PROVENT study in France. Bernard Veekmans, Tommy Rampling, James G. Sullivan, Mark Vishnepolsky, and Priyantha Wijewardane have no disclosures to report. Yousef Fawadleh, Huixia Zhang, Meng Li, Dilki Wickramarachchi, Lauren Hirao, Vitalina Dzutseva, Seth Seegobin, Katie Streicher, Lee-Jah Chang, and Taylor S. Cohen are employees of, and hold or may hold stock in, AstraZeneca. Audrey Sharbaugh, Rohini Beavon, Jesse Thissen, Alexandre Kiazand, John L. Perez, and Mark T. Esser, were employees of AstraZeneca at the time the study was conducted.

: The independent Data Safety Monitoring Board that monitored the PROVENT parent study provided oversight to ensure safe and ethical conduct of the sub-study. The study was performed in accordance with the ethical principles derived from the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation Good Clinical Practice Guidelines, and applicable laws and regulations. The protocol, informed consent form, other relevant documents, and any amendments were approved by an institutional review board/independent ethics committee. All ethics approval details are provided in Online Resource 2.

: All PROVENT parent study participants provided written informed consent before enrollment [ ]. Written informed consent was provided separately for the sub-study before study procedures began.

: Not applicable.

: Not applicable.

: Interim data from the PROVENT sub-study were presented at the OPTIONS IX Congress, September 26–29, 2022, Belfast, UK (Abstract #O-90). Some of the data in this manuscript were presented at the IDWeek 2024 Annual Meeting, October 16–19, Los Angeles, CA, USA (Abstract P-1960).

: Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca's data sharing policy described at . Data for studies directly listed on Vivli can be requested through Vivli at . Data for studies not listed on Vivli could be requested through Vivli at . The AstraZeneca Vivli member page is also available outlining further details: .

: Alexandre Kiazand and Lee-Jah Chang designed the study. Jesse Thissen and Seth Seegobin performed the primary data analyses; Jesse Thissen, Seth Seegobin, and Lee-Jah Chang were involved in data curation. Andrew Ustianowski, Myron J. Levin, Stephane De Wit, Odile Launay, Bernard Veekmans, Tommy Rampling, James G. Sullivan, Mark Vishnepolsky, Priyantha Wijewardane, Alexandre Kiazand, and Mark T. Esser were involved in data collection. Audrey Sharbaugh, Alexandre Kiazand, Mark T. Esser, Lee-Jah Chang, and Taylor S. Cohen provided supervision. Mark T. Esser was involved in project administration and funding acquisition. All authors were involved in writing the original draft of the manuscript and in the reviewing and editing of subsequent drafts and approved the final draft of the manuscript.