Title: “Immunogenicity and lot-to-lot consistency of a ready to use liquid Bovine - human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants”is an ongoing study at KEMHRC, Vadu.

Sponsor/ Collaborator: Serum Institute of India, Pune.

Objective: The objective of the study is to demonstrate non-inferiority in the immunogenicity of LBRV-PV as compared with ROTASIIL (lyophilized BRV-PV) in infants, manufacturing consistency of LBRV-PV by evaluating and comparing the immunogenicity of three cGMP lots and to evaluate the safety of LBRV-PV in terms of immediate post-vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception”. There has been unprecedented demand for rotavirus vaccines. UNICEF and the GAVI Alliance have supported 9 countries to introduce Rotavirus Vaccines (RV) into their national immunization programs and GAVI has approved 20 additional countries for vaccine introduction, with procurement through UNICEF. In spite of this, given the combined surviving infant population of 9 million children around the world, and the existence of only two manufacturers prequalified by WHO to supply the vaccine, a clear and significant shortage of vaccine exists. Liquid vaccines are ready to use, whereas lyophilized ones require mixing of the freeze-dried powder mixed with a liquid diluent to reconstitute the vaccine before administration. Thus making liquid vaccine simpler to administer. Proof of safety and efficacy of the BRV lyophilized and liquid formulation, their licensure by DCGI and prequalification by WHO, along with the vast manufacturing capacity of SIIPL will have a significant impact in filling the gaps for vaccine availability in the future. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards. Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRVPV to Rotasiilwas 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91(0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil group was causally related. LBRV-PV was found similar to Rotasiil_ in terms of safety and immunogenicity and lot-to-lot consistency of LBRV-PV has also been demonstrated. The liquid presentation will give an additional ready to use option of BRV-PV to the health care workers and will try to bridge the demand supply gap.

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