TY - JOUR
T1 - Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants
AU - Kawade, Anand
AU - Babji, Sudhir
AU - Kamath, Veena
AU - Raut, Abhishek
AU - Kumar, Chandra Mohan
AU - Kundu, Ritabrata
AU - Venkatramanan, Padmasani
AU - Lalwani, Sanjay K.
AU - Bavdekar, Ashish
AU - Juvekar, Sanjay
AU - Dayma, Girish
AU - Patil, Rakesh
AU - Kulkarni, Muralidhar
AU - Hegde, Asha
AU - Nayak, Dinesh
AU - Garg, B. S.
AU - Gupta, Subodh
AU - Jategaonkar, Smita
AU - Bedi, Nidhi
AU - Maliye, Chetna
AU - Ganguly, Nupur
AU - Uttam, Kheya Ghosh
AU - Niyogi, Prabal
AU - Palkar, Sonali
AU - Hanumante, Neeta
AU - Goyal, Nidhi
AU - Arya, Alok
AU - Aslam, Mohd
AU - Parulekar, Varsha
AU - Dharmadhikari, Abhijeet
AU - Gaikwad, Dutta
AU - Zade, Jagdish
AU - Desai, Sajjad
AU - Kang, Gagandeep
AU - Kulkarni, Prasad S.
PY - 2019/5/1
Y1 - 2019/5/1
N2 - Background: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency. Methods: This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. 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. Results: Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 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. Conclusion: The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®. Trial registration number: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].
AB - Background: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency. Methods: This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. 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. Results: Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 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. Conclusion: The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®. Trial registration number: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].
UR - http://www.scopus.com/inward/record.url?scp=85063748975&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85063748975&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2019.03.067
DO - 10.1016/j.vaccine.2019.03.067
M3 - Article
C2 - 30955982
AN - SCOPUS:85063748975
SN - 0264-410X
VL - 37
SP - 2554
EP - 2560
JO - Vaccine
JF - Vaccine
IS - 19
ER -
