Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines

Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants

“…Furthermore, there has been evidence from earlier studies in South Africa and Bangladesh which indicates a lack of interference between RIX4414 and OPV in terms of immunogenicity of both vaccines even when the two vaccines were co-administered. 11,12 In our study, we found that at the age of enrolment (eight weeks), about a quarter of the infants were already seropositive for anti-rotavirus IgA. Similarly high initial seropositivity rates (in the absence of prior vaccination) have been observed in South Asia 5.5% in RIX4414 group and 6.6% in placebo group.…”

“…9,11,12 However, higher seroconversion rates have been observed in more developed Asian settings, including infants of Indian ethnicity. 13 While the effect of socio-economic status on the immunogenicity of the vaccine is not fully determined yet, data from a wide range of countries suggest that lower socio-economic status may be associated with lower seroconversion rate, but not necessarily a lower efficacy.…”

Rotavirus vaccines: Opportunities and challenges

“…111 However, this is likely to change with preliminary data presented recently in abstract form of studies examining OPV co-administration with oral rotavirus vaccines. Although a study from South Africa reported that OPV interfered with seroconversion rates for HRV after the first, but not the second, dose of HRV, 133 further trials from Panama and Bangladesh showed concomitant administration of HRV and OPV did not affect the immune response to either vaccine. 134,135 Similarly, another study from Latin America found PRV did not interfere with the immune response to OPV and while co-administration may reduce serum anti-rotavirus IgA levels by about 50% compared to concentrations achieved when OPV was given separately, the rates of anti-rotavirus IgA seroconversion were unchanged and exceeded 90%.…”

Rotavirus vaccines for global use: What are the remaining issues and challenges?

“…Indeed, in a phase II trial of Rotarix™ conducted in South Africa, the IgA antibody seroconversion rates for 2 doses administered at 6 and 10 weeks of age were 36% -43%, compared with a rate of 55% -61% when the 2 doses were given at 10 and 14 weeks. 12 Despite these observations, SAGE recommended that Rotarix™ be administered together with the first and second doses of DTP, which are recommended at 6 and 10 weeks, to maximize immunization coverage of the vaccine. As Rotarix™ and RotaTeq ® are adopted in routine immunization programs, post-licensure evaluations should be conducted to compare vaccine effectiveness at this recommended schedule with efficacy seen in pre-licensure trials, where the vaccine was tested at 6, 10 and 14 week or 10 and 14 week schedules.…”