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Randomized Controlled Trial
. 2016 Feb;137(2):e20152603.
doi: 10.1542/peds.2015-2603. Epub 2016 Jan 28.

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Romina Libster  1 , Monica McNeal  2 , Emmanuel B Walter  3 , Andi L Shane  4 , Patricia Winokur  5 , Gretchen Cress  5 , Andrea A Berry  6 , Karen L Kotloff  6 , Kwabena Sarpong  7 , Christine B Turley  7 , Christopher J Harrison  8 , Barbara A Pahud  8 , Jyothi Marbin  9 , John Dunn  10 , Jill El-Khorazaty  11 , Jill Barrett  11 , Kathryn M Edwards  12 ; VTEU Rotavirus Vaccine Study Work Group
Affiliations
Randomized Controlled Trial

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Romina Libster et al. Pediatrics. 2016 Feb.

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.

Trial registration: ClinicalTrials.gov NCT01266850.

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Figures

FIGURE 1
FIGURE 1
Flowchart. Enrollment, randomization, and follow-up of the study participants.
FIGURE 2
FIGURE 2
Geometric mean titers measured by serum anti-rotavirus IgA levels according the vaccine schedule study groups. Immunogenicity response (GMTs) measured by serum anti-rotavirus IgA levels was comparable for sequential mixed vaccine schedule groups when compared with reference groups against WC3 and 89–12.
See this image and copyright information in PMC

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