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

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish (US)
Article numbere20152603
JournalPediatrics
Volume137
Issue number2
DOIs
StatePublished - Feb 1 2016

Fingerprint

Rotavirus Vaccines
Appointments and Schedules
Vaccines
Safety
Rotavirus
Immunoglobulin A
Vaccination

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Libster, R., McNeal, M., Walter, E. B., Shane, A. L., Winokur, P., Cress, G., ... Edwards, K. M. (2016). Safety and immunogenicity of sequential rotavirus vaccine schedules. Pediatrics, 137(2), [e20152603]. https://doi.org/10.1542/peds.2015-2603

Safety and immunogenicity of sequential rotavirus vaccine schedules. / Libster, Romina; McNeal, Monica; Walter, Emmanuel B.; Shane, Andi L.; Winokur, Patricia; Cress, Gretchen; Berry, Andrea A.; Kotloff, Karen L.; Sarpong, Kwabena; Turley, Christine B.; Harrison, Christopher J.; Pahud, Barbara A.; Marbin, Jyothi; Dunn, John; El-Khorazaty, Jill; Barrett, Jill; Edwards, Kathryn M.

In: Pediatrics, Vol. 137, No. 2, e20152603, 01.02.2016.

Research output: Contribution to journalArticle

Libster, R, McNeal, M, Walter, EB, Shane, AL, Winokur, P, Cress, G, Berry, AA, Kotloff, KL, Sarpong, K, Turley, CB, Harrison, CJ, Pahud, BA, Marbin, J, Dunn, J, El-Khorazaty, J, Barrett, J & Edwards, KM 2016, 'Safety and immunogenicity of sequential rotavirus vaccine schedules', Pediatrics, vol. 137, no. 2, e20152603. https://doi.org/10.1542/peds.2015-2603
Libster R, McNeal M, Walter EB, Shane AL, Winokur P, Cress G et al. Safety and immunogenicity of sequential rotavirus vaccine schedules. Pediatrics. 2016 Feb 1;137(2). e20152603. https://doi.org/10.1542/peds.2015-2603
Libster, Romina ; McNeal, Monica ; Walter, Emmanuel B. ; Shane, Andi L. ; Winokur, Patricia ; Cress, Gretchen ; Berry, Andrea A. ; Kotloff, Karen L. ; Sarpong, Kwabena ; Turley, Christine B. ; Harrison, Christopher J. ; Pahud, Barbara A. ; Marbin, Jyothi ; Dunn, John ; El-Khorazaty, Jill ; Barrett, Jill ; Edwards, Kathryn M. / Safety and immunogenicity of sequential rotavirus vaccine schedules. In: Pediatrics. 2016 ; Vol. 137, No. 2.
@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.}",
year = "2016",
month = "2",
day = "1",
doi = "10.1542/peds.2015-2603",
language = "English (US)",
volume = "137",
journal = "Pediatrics",
issn = "0031-4005",
publisher = "American Academy of Pediatrics",
number = "2",

}

TY - JOUR

T1 - Safety and immunogenicity of sequential rotavirus vaccine schedules

AU - Libster, Romina

AU - McNeal, Monica

AU - Walter, Emmanuel B.

AU - Shane, Andi L.

AU - Winokur, Patricia

AU - Cress, Gretchen

AU - Berry, Andrea A.

AU - Kotloff, Karen L.

AU - Sarpong, Kwabena

AU - Turley, Christine B.

AU - Harrison, Christopher J.

AU - Pahud, Barbara A.

AU - Marbin, Jyothi

AU - Dunn, John

AU - El-Khorazaty, Jill

AU - Barrett, Jill

AU - Edwards, Kathryn M.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84958720444&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84958720444&partnerID=8YFLogxK

U2 - 10.1542/peds.2015-2603

DO - 10.1542/peds.2015-2603

M3 - Article

VL - 137

JO - Pediatrics

JF - Pediatrics

SN - 0031-4005

IS - 2

M1 - e20152603

ER -