Sustained Efficacy of the Pentavalent Rotavirus Vaccine, RV5, up to 3.1 Years Following the Last Dose of Vaccine

Abstract

RVGE-associated hospitalizations and ED visits remain common in the second year of life but decrease in the third year of life. RV5 showed sustained protective efficacy against RVGE-associated hospitalizations and ED visits, regardless of rotavirus serotype, for up to 3.1 years after vaccination.

Decline in rotavirus hospitalizations following the first three years of vaccination in Castile-La Mancha, Spain

“…[10][11][12][13] Other industrialized countries have already shown a reduction in hospital admissions after 1 to 2 y of a complete immunization schedule, [14][15][16] with the vaccine remaining effective up to 3 y after the last dose. 17,18 The aim of our research is to describe the burden borne by hospitals due to community-acquired rotavirus in CLM and its …”

Analysis by rotavirus gene 6 reverse transcriptase-polymerase chain reaction assay of rotavirus-positive gastroenteritis cases observed during the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST)

“…The median clinical severity scores for the RVGE cases among vaccine recipients attributed to vaccine virus were less than the clinical severity scores of RVGE cases attributed to wild-type rotavirus, as follows: for RVGE cases attributed to vaccine virus, the median clinical severity score was 4 (range, 1-11) and for RVGE cases attributed to wild-type rotavirus, the median clinical severity score was 6 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17]. The median clinical severity score of RVGE cases among placebo recipients was 10 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19], which is indicative of moderate-to-severe RVGE.…”

“…The median clinical severity score of RVGE cases among placebo recipients was 10 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19], which is indicative of moderate-to-severe RVGE. The median score reduction between the wild-type RVGE cases among placebo recipients and vaccine-type RVGE among vaccine recipients was 6 (95% confidence interval [CI]: 4, 7); whereas, the median score reduction between the wild-type RVGE cases among placebo recipients and wild-type RVGE among vaccine recipients was 4 (95% CI: -1, 7).…”

“…This finding comes in addition to the per-protocol results from REST that showed that completion of the 3-dose series provides durable and optimal protection. 5,6 Overall, according to the rotavirus gene 6 RT-PCR assay the rate of occurrence of vaccine-type RVGE was 2.5% in the clinical-efficacy cohort, which captured all severities of illness, and 0.04% in the large-scale cohort of REST, which captured all RVGE-related hospitalizations and ED visits. These results are consistent with previous findings, which showed that RV5 was well tolerated, with a slight (1.3%) increase in the rates of mild vomiting and mild diarrhea within the first week after the first dose.…”

“…6 During the vaccination phase of REST, the period beginning the day of administration of dose 1 through 13 d after the administration of dose 3, more wild-type RVGE cases occurred among the vaccine recipients compared with placebo recipients using the protocol-specified microbiological plaque assay in the clinical-efficacy (N = 5,673) trial cohort, a subset of subjects where vaccine efficacy against RVGE of any severity was assessed. In the clinical-efficacy cohort, 62% of such cases occurred among the vaccine recipients, even though the study was randomized 1:1 to receive RV5 or placebo.…”