Study concept and design: Mulligan, Bernstein, Winokur, Rupp, Hill, Bellamy.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Mulligan, Bernstein, Winokur, Rupp, Anderson, Bellamy.
Critical revision of the manuscript for important intellectual content: Mulligan, Bernstein, Anderson, Rouphael, Dickey, Stapleton, Edupuganti, Spearman, Ince, Noah, Hill.
Statistical analysis: Mulligan, Hill, Bellamy.
Obtained funding: Mulligan, Bernstein, Winokur, Rupp, Noah, Hill.
Administrative, technical, or material support: Mulligan, Bernstein, Winokur, Anderson, Rouphael, Dickey, Stapleton, Ince, Noah.
Study supervision: Mulligan, Bernstein, Winokur, Anderson, Rupp, Noah, Hill.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Mulligan reported serving on a data and safety monitoring committee for VaxInnate Inc and receiving a personal fee for this service. No other disclosures were reported.
Funding/Support: This project has been funded in whole or in part with 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 under contracts HHSN272200800005C (Emory University), HHSN272200800006C (Cincinnati Children’s Hospital Medical Center), HHSN272200800008C (University of Iowa, Iowa City), HHSN272200800002C (Baylor University College of Medicine and subcontractor University of Texas Medical Branch), HHSN272201200003I and HHSN27200003 (Battelle and subcontractor Southern Research Inc), and HHSN272200800013C (EMMES Corporation). Additional support was provided by the Georgia Research Alliance, Children’s Healthcare of Atlanta, and the National Center for Advancing Translational Sciences of the National Institutes of Health under awards UL1TR000454 and UL1TR000442. The authors and participating faculty and staff were compensated for their work on this project through the US government contracts to their institutions listed above. The vaccine and adjuvant provided by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority from the National Pre-pandemic Influenza Vaccine Stockpile and were manufactured by Sanofi Pasteur (H7N9 vaccine) and Novartis Vaccines (M59 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.
Group Information: The DMID 13-0032 H7N9 Vaccine Study Group includes the authors listed in the byline and the following participating investigators and staff from our institutions who contributed to the conduct of the study and data collection: Karen Mask, MPH, RN, Allison Beck, PA-C, Lilin Lai, MD, Nayoka Rimann, BS, Colleen Kelley, MD, Melinda Ogilvie, BS, Eileen Osinski, BS, Dawn Battle (Hope Clinic of the Emory Vaccine Center); Andres Camacho-Gonzalez, MD, Anita McElroy, PhD, MD, Andi Shane, MD, MPH, MSc, Larry Anderson, MD, Kathy Stephens, RN, MSN, Brooke Hartwell, RN, BS, Teresa Ball, RN, BA, Laila Hussani, BS, Theda Gibson, MS, Melanie Johnson, BS, Bethany Sederdahl, BS, Natasha Mann, BA (Emory Children’s Center); Robert Frenck, MD, Rebecca Brady, MD, Tara Foltz, BA, Amy Cline, BSN, Sarah McCartney, BSN, Margery Huron, BSN (Cincinnati Children’s Hospital Medical Center); Jeffrey Meier, MD, Margo Schilling, MD, Nancy Wagner, RN, Geraldine Dull, BA, Kathy Flanders, ARNP, Dan Zhao, RN, Mary Reidy, RN, Gretchen Cress, RN, Nikki Gerot, BA (University of Iowa); Diane Barrett, MS, Carrie Harrington, RN, Amy McMahan, LVN, Marianne Shafer, BA, Lori Simon, BSN (University of Texas Medical Branch); Barbara Taggart, BS, Valerie Johnson, BS, Donna Bowen, AS, Shixiong Li, MS, Candi Looney, BS, MBA, Megan May, BS, Rachel May, BS, Lawanda Parker, BS, Bridgette Myers, BS, Nertaissa Cochran, BS, Michelle Bell, Logan Haller, PMP (Southern Research Institute); Claire Stablein, BS, Sara Marshall, PhD, Megan McDonough, MPH, Fenhua He, MS, Kuo Guo, MS (EMMES Corporation); and Linda Lambert, PhD, Wendy Buchanan, MS, Valerie Riddle, MD, Suzanne Murray, RN, BSN, Richard Gorman, MD (National Institute of Allergy and Infectious Diseases DMID Respiratory Diseases Branch).
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Previous Presentation: This work was presented in part at the Second World Health Organization Integrated Meeting on Development and Clinical Trials of Influenza Vaccines that Induce Broadly Protective and Long-Lasting Immune Responses; May 5-7, 2014; Geneva, Switzerland.
Additional Contributions: The investigators at the 4 National Institute of Allergy and Infectious Diseases Vaccine and Treatment Evaluation Units thank the study participants who made this study possible. We are grateful for the manuscript review expertise provided by following colleagues at the US Department of Health and Human Services: Robin Robinson, PhD, Rick Bright, PhD, Michael O’Hara, PhD, Corrina Pavetto, MS, Bai Yeh, MBA, Vittoria Cioce, PhD, James King, MD, and Karen Biscardi, MS. These individuals were not specifically compensated for these contributions.