Immunogenicity of a three dose and five dose oral human rotavirus vaccine (RIX4414) schedule in south Indian infants

Abstract

Rotarix vaccine showed low immunogenicity in south Indian children and increasing the number of doses did not increase the proportion of infants seroconverting after vaccination.

A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

“…The rate of IgA seroresponses observed in this population (33%), while low, is similar to that of other rotavirus vaccine studies in India [29] . Responses to all three serotypes in the concomitantly administered oral poliovirus vaccine (OPV) were similar among placebo and vaccine recipients, demonstrating that BRV-PV did not interfere with OPV takes, a general concern that has been raised for other rotavirus vaccines, but which has not been substantiated for any [30] , [31] .…”

Association of human leukocyte antigen alleles and supertypes with immunogenicity of oral rotavirus vaccine given to infants in China

“…The low baseline IgA seropositivity indicated that most of the participants were not infected by RV before vaccination, thereby eliminating the effect of pre-infection on the immunogenicity of vaccine, which was observed in south Indian infants. [ 9 ] The results of our study show that RV3 is immunogenic in 62% of participants with a seroconversion detected, which is similar to that of Rotarix in China [ 7 ] ( P = .06) but lower than that of Rotarix studies conducted in Finland and France. [ 6 – 8 ]…”

“…Previous studies indicate that RV vaccines showed distinct immunogenicity and efficacy in different clinical trials. [ 5 ] Seroconversion rates of Rotarix are 84% to 95% in Finland [ 6 ] and France, [ 7 , 8 ] whereas they are 30% to 40% lower in India [ 9 ] and South Africa, [ 7 , 10 ] where the vaccine is needed most. In China, the seroconversion rate of Rotarix is 71%, [ 7 ] lower than that in Finland and France.…”

Rotavirus Vaccine Schedules and Vaccine Response Among Infants in Low- and Middle-Income Countries: A Systematic Review

“…The sample size was estimated using the estimate of seroconversion proportion and 95% confidence interval to solve for the standard error and sample size. In addition, one trial, Clinical Trials Registry of India (CTRI)-2012-02-002454, did not report 95% confidence intervals for seroconversion proportion [19]. Exact confidence intervals were estimated using the sample size and seroconversion proportion estimate.…”