Non-interference of rotavirus vaccine with measles-rubella vaccine at 9 months and improvements in anti-rotavirus immunity: a randomized trial

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2016
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Background. The burden of rotavirus morbidity and mortality is high in children under 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, however co-administration should not interfere with immune responses to concurrently given vaccines. Methods. Enrolling 480 9-month old participants from Matlab, Bangladesh, the primary objective was to establish non-inferiority of concomitant administration of measles-rubella (MR) vaccine and a 3rddose of human monovalent rotavirus vaccine (HRV) [MR+HRV] compared to MR vaccine given alone [MR]. Secondary objectives included non-inferiority of rubella antibody seroconversion and evaluating rotavirus IgA/IgG seroresponses in MR+HRV participants. Results. Two months post-vaccination, 75.3% and 74.3% of MR+HRV and MR group infants, respectively, had seroprotective levels of measles virus antibodies. 100.0% and 99.6%, respectively, showed anti-rubella IgG seroprotection. In the MR+HRV group, pre-vaccination anti-rotavirus IgA and IgG seropositivities (52.7% and 66.3%, respectively) increased to 69.6% and 88.3% post-vaccination. Conclusions. Vaccine-induced measles and rubella antibody responses are not negatively affected by concomitant administration of HRV. The HRV dose increases anti-rotavirus serum antibody titres and the proportion of infants with detectable anti-rotavirus antibody