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Randomized Controlled Trial
. 2016 Jun 1;213(11):1686-93.
doi: 10.1093/infdis/jiw024. Epub 2016 Jan 27.

Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial

K Zaman  1 , Jessica A Fleming  2 , John C Victor  2 , Mohammad Yunus  1 , Tajul Islam A Bari  3 , Tasnim Azim  1 , Mustafizur Rahman  1 , Syed Mohammad Niaz Mowla  1 , William J Bellini  4 , Monica McNeal  5 , Joseph P Icenogle  4 , Ben Lopman  4 , Umesh Parashar  4 , Margaret M Cortese  4 , A Duncan Steele  2 , Kathleen M Neuzil  2
Affiliations
Randomized Controlled Trial

Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial

K Zaman et al. J Infect Dis. .

Abstract

Background: The burden of rotavirus morbidity and mortality is high in children aged <5 years in developing countries, and evaluations indicate waning protection from rotavirus immunization in the second year. An additional dose of rotavirus vaccine may enhance the immune response and lengthen the period of protection against disease, but coadministration of this dose should not interfere with immune responses to concurrently given vaccines.

Methods: A total of 480 9-month-old participants from Matlab, Bangladesh, were enrolled in a study with a primary objective to establish noninferiority of concomitant administration of measles-rubella vaccine (MR) and a third dose of human rotavirus vaccine (HRV; MR + HRV), compared with MR given alone. Secondary objectives included noninferiority of rubella antibody seroconversion and evaluating rotavirus IgA/IgG seroresponses in MR + HRV recipients.

Results: Two months after vaccination, 75.3% and 74.3% of MR + HRV and MR recipients, respectively, had seroprotective levels of measles virus antibodies; 100.0% and 99.6%, respectively, showed anti-rubella virus immunoglobulin G (IgG) seroprotection. In the MR + HRV group, antirotavirus immunoglobulin A and IgG seropositivity frequencies before vaccination (52.7% and 66.3%, respectively) increased to 69.6% and 88.3% after vaccination.

Conclusions: Vaccine-induced measles and rubella antibody responses are not negatively affected by concomitant administration of HRV. The HRV dose increases antirotavirus serum antibody titers and the proportion of infants with detectable antirotavirus antibody.

Clinical trials registration: NCT01700621.

Keywords: measles vaccine; non-interference; rotavirus vaccine; rubella vaccine; vaccine co-administration.

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Figures

Figure 1.
Figure 1.
Trial profile. Abbreviations: HRV, human rotavirus vaccine; MR, measles-rubella vaccine; SNA, serum neutralizing antibody.
Figure 2.
Figure 2.
Reverse cumulative distribution plot of antirotavirus immunoglobulin A (IgA) concentrations (U/mL) (A) and anti-rotavirus IgG concentrations (U/mL) (B) before vaccination and 2 months after vaccination among infants who received measles-rubella vaccine plus human rotavirus vaccine. Data are for all randomized children with prevaccination and postvaccination serum samples and rotavirus test results available.
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References

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