Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Romina Libster; Monica McNeal; Emmanuel B Walter; Andi L Shane; Patricia Winokur; Gretchen Cress; Andrea A Berry; Karen L Kotloff; Kwabena Sarpong; Christine B Turley; Christopher J Harrison; Barbara A Pahud; Jyothi Marbin; John Dunn; Jill El-Khorazaty; Jill Barrett; Kathryn M Edwards; VTEU Rotavirus Vaccine Study Work Group

doi:10.1542/peds.2015-2603

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Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Journal article

Open access

Peer reviewed

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Romina Libster, Monica McNeal, Emmanuel B Walter, Andi L Shane, Patricia Winokur, Gretchen Cress, Andrea A Berry, Karen L Kotloff, Kwabena Sarpong, Christine B Turley, …

Pediatrics (Evanston), Vol.137(2), pp.e20152603-e20152603

02/2016

DOI: 10.1542/peds.2015-2603

PMCID: PMC4732359

PMID: 26823540

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Abstract

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. 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. 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. Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.

Patient Safety

Enzyme-Linked Immunosorbent Assay

Rotavirus Vaccines - immunology

Humans

Rotavirus - immunology

Rotavirus Vaccines - adverse effects

Female

Immunization Schedule

Infant

Male

Biomarkers - blood

Antibodies, Viral - blood

Details

Title: Subtitle: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Creators: Romina Libster - Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, Tennessee; Fundación INFANT, CABA, Argentina; National Scientific and Technical Research Council (CONICET), CABA, Argentina
Monica McNeal - Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
Emmanuel B Walter - Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina
Andi L Shane - Emory University School of Medicine, Atlanta, Georgia
Patricia Winokur - University of Iowa, Iowa City, Iowa
Gretchen Cress - University of Iowa, Iowa City, Iowa
Andrea A Berry - Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland
Karen L Kotloff - Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland
Kwabena Sarpong - The University of Texas Medical Branch, Galveston, Texas
Christine B Turley - The University of Texas Medical Branch, Galveston, Texas
Christopher J Harrison - Children's Mercy Hospital, Kansas City, Missouri
Barbara A Pahud - Children's Mercy Hospital, Kansas City, Missouri
Jyothi Marbin - UCSF Benioff Children's Hospital Oakland, California
John Dunn - Group Health Cooperative, Seattle, Washington; and
Jill El-Khorazaty - Emmes Corporation, Rockville, Maryland
Jill Barrett - Emmes Corporation, Rockville, Maryland
Kathryn M Edwards - Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, Tennessee; kathryn.edwards@vanderbilt.edu
VTEU Rotavirus Vaccine Study Work Group
Resource Type: Journal article
Publication Details: Pediatrics (Evanston), Vol.137(2), pp.e20152603-e20152603
DOI: 10.1542/peds.2015-2603
PMID: 26823540
PMCID: PMC4732359
NLM abbreviation: Pediatrics
ISSN: 0031-4005
eISSN: 1098-4275
Publisher: American Academy of Pediatrics
Grant note: HHSN27220800008C / PHS HHS UL1 RR024975 / NCRR NIH HHS KL2 RR024977 / NCRR NIH HHS HHSN272200800057C / PHS HHS HHSN272200800006C / PHS HHS HHSN272200800057C / NIAID NIH HHS HHSN272200800013C / NIAID NIH HHS UL1RR024975-01 / NCRR NIH HHS HHSN27220080000C / PHS HHS HHSN272200800004C / NIAID NIH HHS U54 TR001356 / NCATS NIH HHS HHSN272200800006C / NIAID NIH HHS U54 TR001013 / NCATS NIH HHS HHSN272200800013C / PHS HHS U54TR001013 / NCATS NIH HHS HHSN272200800004C / PHS HHS UI PO 1000920057 / PHS HHS
Language: English
Date published: 02/2016
Academic Unit: Infectious Diseases; Stead Family Department of Pediatrics; Gastroenterology, Hepatology, Pancreatology, and Nutrition; Medicine Administration; Internal Medicine
Record Identifier: 9984093210602771

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