Study concept and design: Jackson, Campbell, Keitel, Kotloff, Creech.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Jackson, Keitel, Anderson, Bellamy.
Critical revision of the manuscript for important intellectual content: Jackson, Campbell, Frey, Edwards, Keitel, Kotloff, Berry, Graham, Atmar, Creech, Thomsen, Patel, Gutierrez, Sahly, Hill, Noah.
Statistical analysis: Jackson, Bellamy.
Obtained funding: Jackson, Edwards, Keitel, Kotloff, Noah.
Administrative, technical, or material support: Jackson, Campbell, Frey, Keitel, Kotloff, Berry, Creech, Thomsen, Anderson, Noah.
Study supervision: Jackson, Campbell, Edwards, Keitel, Kotloff, Gutierrez, Sahly.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Jackson reports receiving funding from Novavax for the conduct of a clinical trial of an unrelated vaccine. Dr Frey reports receiving funding from Novartis and from GlaxoSmithKline for the conduct of influenza vaccine trials. Dr Edwards reports receiving grant funding from Novartis for a study of an unrelated vaccine and serving on a data and safety monitoring board for a seasonal influenza vaccine made by Novartis. Dr Keitel reports serving as an unpaid advisor to ContraFect-flu antibodies and as an unpaid program reviewer for GlaxoSmithKline. Dr Kotloff reports receiving grant funding from Merck for an unrelated vaccine. Dr Creech reports receiving grant funding from Pfizer and from Novartis Vaccines for unrelated work. Dr El Sahly reports receiving grants to conduct clinical research from Protein Sciences Corp. No other disclosures were reported.
Funding/Support: This work was supported by federal funds from the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, and the US Department of Health and Human Services (contracts HHSN272200800004C [Group Health], HHSN27220080000C [Vanderbilt University], HHSN272200800001C [University of Maryland], HHSN272200800002C [Baylor College of Medicine], HHSN272200800003C [Saint Louis University], HHSN2722012000031 and HHSN27200003 [Battelle and subcontractor Southern Research], and HHSN272200800013C [EMMES Corporation]). At the University of Maryland, partial support was also provided by additional funding sources, including grant M01-RR-016500 from the University of Maryland General Clinical Research Center and grant K12-RR-023250 from the National Center for Research Resources. The vaccine and adjuvants were provided by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority from the national prepandemic influenza vaccine stockpile and were manufactured by Sanofi Pasteur (H7N9 vaccine), Novartis Vaccines (MF59 adjuvant), and GlaxoSmithKline (AS03 adjuvant).
Role of the Funders/Sponsors: The funders/sponsors participated in the design and monitoring of the study; and the review and approval of the manuscript. The funders/sponsors did not participate in the collection, management, analysis, and interpretation of the data; the preparation of the manuscript; or the decision to submit the manuscript for publication. The study product manufacturers had no role in the conduct of the study, analysis of the data, or preparation of this report.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Additional Contributions: The investigators at the 5 National Institute of Allergy and Infectious Diseases Vaccine and Treatment Units thank the various groups that made this trial possible: Linda Lambert, PhD, Wendy L. Buchanan, BSN, MS, Valerie Riddle, MD, Soju Chang, MD, MPH, Rhonda Pikaart-Tautges, BSBA, BS, Suzanne Murray, RN, BSN, Richard Gorman, MD (National Institute of Allergy and Infectious Diseases); Michael O’Hara, PhD, Corrina Pavetto, MS, Bai Yeh, MBA, Vittoria Cioce, PhD, Karen Biscardi, MS (Biomedical Advanced Research and Development Authority); Jeanne S. Sheffield, MD, Robert A. Salata, MD, H. Cody Meissner, MD, Richard Webby, PhD, and Maria Deloria Knoll, PhD (data and safety monitoring board). We also thank each member of the study teams for their important contributions to the conduct of this clinical trial: Kathleen Koehler, RN, Thomas Pacatte, BSN, MSW, RN, Janice Tennant, MPH, RN, Sabrina DiPiazza, BSN, RN, Linda Eggemeyer, BSN, RN, Kathleen Geldmacher, RN, Sharon Irby-Moore, MPH, RN, Mary Margaret Donavan MSN, RN, Joan Siegner, MSN, RN, Karla Mosby, RN, Carol Duane, PhD, RN, Richard Nickel, RPh, Nicole Purcell, Maria Woodson (Saint Louis University); Nancy Greenberg, RN, MS, Ginny Cummings, CRNP, Robin Barnes, CRNP, Milagritos Tapia, MD, Mark Travassos, MD, Monica McArthur, MD, PhD, Barbara Jean Albert, MD, Mardi Reymann, BS, Inna Ruslanova, MS, Brenda Dorsey, BSN, MS, CCRP, Alyson Kwon, BA, CCRC, Kimberly Wilhelmi, RN, BSN, MS, Naya Komninou, BA, Sandra Getlein, RN, Nancy Wymer, RN, Linda Wadsworth, RN, Myounghee Lee, PharmD, PhD, CCRP, Gillian Freedman, BA, Stephen Yu, BS, Sana IqBal, BS, MS, and the expert nursing assistance (University of Maryland School of Medicine); Todd Callahan, MD, MPH, Leigh Howard, MD, MPH, Kalpana Manthiram, MD, Elizabeth Williams, MD, MPH, Ashley Chadha, MD, Kim Fortner, MD, Deborah Myers, Debbie Hunter, BSN, Gayle Johnson, RN, Shanda Phillips, BSN, Wendi McDonald, BSN, Sara Anderson, Julie Anderson, RN, Mary Jones, RN, Kevin Booth, MBA, Roberta Winfrey, Megan Baker, Amy Kinsey (Vanderbilt University); Tracey Lanford, RN, Celsa Tajonera, RN, Nanette Bond, PA, Janet Brown, RPh, JD, Connie Rangel, RN, Virginia Mancha, MA, Annette Nagel, RN, Pedro A. Piedra, MD, Kathy Bosworth, BA, Jesus Banay, BS, Kirtida Patel, BS, Sneha Thakar, BS, Yvette Rugeley, Gwen Bennett, BBA, Verna Manley, Richard Hamill, MD, Mark Udden, MD (Baylor College of Medicine); Barbara Carste, MPH, Maya Dunstan, MS, RN, Patty Starkovich, RN, Janice Suyehira, MD, Colin Fields, MD, John Dunn, MD, MPH, Joyce Benoit, RN, Joanne Greene, MBA, RN, Jennifer Gross, MS, RN, Michelle Hill, MS, RN, Steve Koets, RN, Rebecca Lederman, RN, Angel Mathis, MN, MPH, ARNP, Alyssa Spingola, MN, ARNP, Hallie Phillips. MEd, Tom Archer, PharmD, Joyce Liew, PharmD, Michael Witte, PharmD, Lawrence Madziwa, MS, Matt Nguyen, MPH, Patti Benson, MPH, Scott Caparelli, BS, Alisa Fairweather, BS, Sarah Kotowski, PhD, JoAnn Lorenzo, BS, Mihir Parikh, BS, and Christine Truong, BS (Group Health). No one received additional compensation for their contribution.