@article{d3a2318c149f4f3982af2bb114af084f,
title = "Safety and immunogenicity of sequential rotavirus vaccine schedules",
abstract = "BACKGROUND AND OBJECTIVES: Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone. METHODS: Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A >20 U/mL) were compared in all the vaccine groups. RESULTS: Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated. CONCLUSIONS: Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.",
author = "Romina Libster and Monica McNeal and Walter, {Emmanuel B.} and Shane, {Andi L.} and Patricia Winokur and Gretchen Cress and Berry, {Andrea A.} and Kotloff, {Karen L.} and Kwabena Sarpong and Turley, {Christine B.} and Harrison, {Christopher J.} and Pahud, {Barbara A.} and Jyothi Marbin and John Dunn and Jill El-Khorazaty and Jill Barrett and Edwards, {Kathryn M.}",
note = "Funding Information: The authors thank Prof David Bernstein, Cincinnati Children''s Hospital Medical Center, for proposing the study design and for his insights and guidance on its conduct, and to the various groups that made this trial possible: Suzanne Murray, RN, BSN, Richard Gorman, MD, (National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases); Fred Cassels, PhD, Shahida Baqar, PhD, Diana Berard, Gabriele Feolo, and Stephanie Zafonte, MSN, RN, (Enteric and Hepatic Diseases Branch, DMID); the members of the Safety Monitoring Committee (Drs Penelope Dennehy, David Matson, and Derek Williams). We also thank each member of the study teams for their important contributions to the conduct of this clinical trial: 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, and Amy Kinsey (Vanderbilt University); Lynn Harrington, RN, BSN, Lori Hendrickson, RN, BSN, Beth Patterson, RN, BSN, Liz Fisher, Luis Ballon, Bethany Applebome, Devon Clark, and the nursing staff of Duke Children''s Primary Care and Durham Pediatrics (Duke University Health System); Nicole Meyer, MS, Courtney Rhorer, BS, and Brandi Phillips, MS (Cincinnati Children''s Hospital); Brooke Hartwell, RN, BSN; Melanie A. Johnson, BS; the physicians and staff of Children''s Medical Group; Kathy A. Stephens, RN, MSN; Andres F. Camacho-Gonzalez, MD, MSc; Theda Gibson, MS; Jianguo Xu, RPh, PhD; Susan D. Rodgers, BS (Emory University); Manuela Murray, MD, Peggy Haardt, PA-C and the Division of General Pediatrics Faculty (University of Texas Medical Branch), Richard Rupp, MD, Kristin Pollock, RN, Lori Simon, BSN, CCRP, Marianne Shafer, BA, CCRP, and staff from the Sealy Center For Vaccine Development (University of Texas Medical Branch); Kathy Flanders, ARNP, Gretchen Cress, RN, MPH, Mary Reidy, RN, Ellen Segar, RN, Jin Zhou, RN, Ruthann Schrock, RN, and Michelle Rodenburg and the rest of the VTEU team at the University of Iowa; Cyrille Amegashie, MPH, Mark Wolff, PhD (Emmes); Patricia Chase, MD, Mindy Benson, PNP, Adam Davis, Cindy Nelson Purdy, PNP, Hollie Stessel, Roberto Mok (UCSF Benioff Children''s Hospital Oakland); Lisa Jackson, MD, MPH, Barbara Carste, MPH, Maya Dunstan, MS, RN, Patty Starkovich, RN, Janice Suyehira, MD, Alyssa Spingola, MN, ARNP, Angel Mathis, MN, MPH, ARNP, Joyce Benoit, RN, Joanne Greene, MBA, RN, Michelle Hill, MS, RN, Lawrence Madziwa, MS, Hallie Phillips, MEd, Michael Witte, PharmD, (Group Health Cooperative); Kimberly Wilhelmi, RN, BSN, MS, Linda Wadsworth, RN, Nancy Wymer, RN, BSN, Ginny Cummings, MS, CRNP; Charles Parmele, MD, and the members of Annapolis Pediatrics; Wayne Crowder, MD, and the members of The Pediatric Center of Frederick, LLC; Samer El-Kamary, MB, ChB, MPH; Susan Feigelman, MD, and the members of University of Maryland Pediatrics at UMMC Midtown Campus (University of Maryland); Nancy Neilan, MT (ASCP), CCRC; Shannon Clark, MPH, CCRC, Whitley Albright, RN, BSN, CCRC, Michele Rooney, BSN, RN, CPN; Jami Penny, LPN, CCRC; CCRC; Georgann Meredith, RN, CCRC (Children''s Mercy Hospital, Kansas City). Additional members of the VTEU Rotavirus Vaccine Study Work Group are as follows: Natasha Halasa, MD, MPH, C. Buddy Creech, MD, MPH, Todd S. Callahan, MD, MPH, Leigh Howard, MD, MPH, Kalpana Manthiram, MD, S. Elizabeth Williams, MD, MPH, Ashley Chadha, MD; Kim Fortner, MD (Vanderbilt University); Douglas Clark, MD, Carol Burk, MD, Lisa Ferrari, MD, Jeffrey Greene, MD, PhD, Martha Gagliano, MD, James Troutman, MD, Elaine Matheson, RN, MSN, CPNP, Elizabeth Landolfo, MD, Brian Eichner, MD, Dennis Clements, MD, MPH, PhD (Duke University Health System); Terry Buford, CPNP, Kirsten Weltmer, MD, Melissa Seybert, PNP, Robyn Livingston, MD, Angela Myers, MD (Children''s Mercy Hospital, Kansas City); and Anita Moonjely, MD, Riad Rahhal, MD, MS, Timothy Starner, MD (University of Iowa). Dr Libster has served as a consultant to Merck on an unrelated topic. Dr Walter has served as a consultant to Merck, as a DSMB (Data and Safety Monitoring Board) member for Novartis, and has served as an investigator for clinical studies funded by bioCSL, GlaxoSmithKline, Merck, Pfi zer, Novartis, and Novavax. Ms McNeal has laboratory service agreements with Merck and GSK. Dr Edwards has served as a DSMB member for Novartis and has research funding from Novartis for unrelated vaccine studies. Dr Berry has served as an investigator for clinical studies funded by GlaxoSmithKline, Novartis, Pfi zer, and Sanofi Pasteur. Dr Sarpong has served as a clinical investigator to clinical trials for unrelated trials with GlaxoSmithKline, Merck, and Sanofi Pasteur. Dr Harrison has served as investigator for clinical studies funded by GlaxoSmithKline, Pfi zer Inc, and Gilead. Dr Pahud has served on advisory boards for Pfi zer and Sanofi and has served as investigator for clinical studies funded by GlaxoSmithKline, Pfi zer Inc, and Gilead. Dr Kotloff is an investigator on a study funded by Merck. Dr Turley has served as investigator for unrelated trials with GlaxoSmithKline, Merck, Pfi zer, and Sanofi Pasteur, and holds publicly traded Abbott and Pfi zer stock. The other authors have indicated they have no potential confl icts of interest to disclose. Supported by 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 HHSN27220080000C (Vanderbilt University); HHSN272200800057C (University of Maryland, Baltimore); HHSN272200800006C (Cincinnati Children''s Hospital, Cincinnati, OH); HHSN27220800008C (University of Iowa); HHSN272200800004C (Group Health Cooperative); and HHSN272200800013C (Emmes Corporation). At Vanderbilt, partial support was also provided by CTSA (Clinical and Translational Science Awards) grant UL1 RR024975-01 from the National Institutes of Health. The University of Iowa used resources that have been supported by the CTSA grant from NCATS (National Center for Advancing Translational Sciences): U54TR001013. Children''s Mercy Hospital, Kansas City, used funds form DMID (Division of Microbiology and Infectious Diseases) under subcontract form The University of Iowa from UI PO 1000920057. Funded by the National Institutes of Health (NIH). Publisher Copyright: Copyright {\textcopyright} 2016 by the American Academy of Pediatrics.",
year = "2016",
month = feb,
doi = "10.1542/peds.2015-2603",
language = "English (US)",
volume = "137",
journal = "Pediatrics",
issn = "0031-4005",
publisher = "American Academy of Pediatrics",
number = "2",
}