Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants

Anand Kawade; Sudhir Babji; Veena Kamath; Abhishek Raut; Chandra Mohan Kumar; Ritabrata Kundu; Padmasani Venkatramanan; Sanjay K. Lalwani; Ashish Bavdekar; Sanjay Juvekar; Girish Dayma; Rakesh Patil; Muralidhar Kulkarni; Asha Hegde; Dinesh Nayak; B. S. Garg; Subodh Gupta; Smita Jategaonkar; Nidhi Bedi; Chetna Maliye; Nupur Ganguly; Kheya Ghosh Uttam; Prabal Niyogi; Sonali Palkar; Neeta Hanumante; Nidhi Goyal; Alok Arya; Mohd Aslam; Varsha Parulekar; Abhijeet Dharmadhikari; Dutta Gaikwad; Jagdish Zade; Sajjad Desai; Gagandeep Kang; Prasad S. Kulkarni

doi:10.1016/j.vaccine.2019.03.067

Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants

Anand Kawade, Sudhir Babji, Veena Kamath, Abhishek Raut, Chandra Mohan Kumar, Ritabrata Kundu, Padmasani Venkatramanan, Sanjay K. Lalwani, Ashish Bavdekar, Sanjay Juvekar, Girish Dayma, Rakesh Patil, Muralidhar Kulkarni, Asha Hegde, Dinesh Nayak, B. S. Garg, Subodh Gupta, Smita Jategaonkar, Nidhi Bedi, Chetna MaliyeNupur Ganguly, Kheya Ghosh Uttam, Prabal Niyogi, Sonali Palkar, Neeta Hanumante, Nidhi Goyal, Alok Arya, Mohd Aslam, Varsha Parulekar, Abhijeet Dharmadhikari, Dutta Gaikwad, Jagdish Zade, Sajjad Desai, Gagandeep Kang, Prasad S. Kulkarni^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

18 Citations (Scopus)

Abstract

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].

Original language	English
Pages (from-to)	2554-2560
Number of pages	7
Journal	Vaccine
Volume	37
Issue number	19
DOIs	https://doi.org/10.1016/j.vaccine.2019.03.067
Publication status	Published - 01-05-2019

All Science Journal Classification (ASJC) codes

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.vaccine.2019.03.067

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Kawade, A., Babji, S., Kamath, V., Raut, A., Kumar, C. M., Kundu, R., Venkatramanan, P., Lalwani, S. K., Bavdekar, A., Juvekar, S., Dayma, G., Patil, R., Kulkarni, M., Hegde, A., Nayak, D., Garg, B. S., Gupta, S., Jategaonkar, S., Bedi, N., ... Kulkarni, P. S. (2019). Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants. Vaccine, 37(19), 2554-2560. https://doi.org/10.1016/j.vaccine.2019.03.067

@article{30d85edcb86e4757b65a35ad7ae0ad44,

title = "Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants",

abstract = "Background: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil{\textregistered}) 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{\textregistered} 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{\textregistered} 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{\textregistered} 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{\textregistered} group was causally related. Conclusion: The immunological non-inferiority of LBRV-PV against Rotasiil{\textregistered} as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil{\textregistered}. Trial registration number: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].",

author = "Anand Kawade and Sudhir Babji and Veena Kamath and Abhishek Raut and Kumar, {Chandra Mohan} and Ritabrata Kundu and Padmasani Venkatramanan and Lalwani, {Sanjay K.} and Ashish Bavdekar and Sanjay Juvekar and Girish Dayma and Rakesh Patil and Muralidhar Kulkarni and Asha Hegde and Dinesh Nayak and Garg, {B. S.} and Subodh Gupta and Smita Jategaonkar and Nidhi Bedi and Chetna Maliye and Nupur Ganguly and Uttam, {Kheya Ghosh} and Prabal Niyogi and Sonali Palkar and Neeta Hanumante and Nidhi Goyal and Alok Arya and Mohd Aslam and Varsha Parulekar and Abhijeet Dharmadhikari and Dutta Gaikwad and Jagdish Zade and Sajjad Desai and Gagandeep Kang and Kulkarni, {Prasad S.}",

note = "Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd",

year = "2019",

month = may,

day = "1",

doi = "10.1016/j.vaccine.2019.03.067",

language = "English",

volume = "37",

pages = "2554--2560",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier Ltd",

number = "19",

}

Kawade, A, Babji, S, Kamath, V, Raut, A, Kumar, CM, Kundu, R, Venkatramanan, P, Lalwani, SK, Bavdekar, A, Juvekar, S, Dayma, G, Patil, R, Kulkarni, M, Hegde, A, Nayak, D, Garg, BS, Gupta, S, Jategaonkar, S, Bedi, N, Maliye, C, Ganguly, N, Uttam, KG, Niyogi, P, Palkar, S, Hanumante, N, Goyal, N, Arya, A, Aslam, M, Parulekar, V, Dharmadhikari, A, Gaikwad, D, Zade, J, Desai, S, Kang, G & Kulkarni, PS 2019, 'Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants', Vaccine, vol. 37, no. 19, pp. 2554-2560. https://doi.org/10.1016/j.vaccine.2019.03.067

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].

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DO - 10.1016/j.vaccine.2019.03.067

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AN - SCOPUS:85063748975

SN - 0264-410X

VL - 37

SP - 2554

EP - 2560

JO - Vaccine

JF - Vaccine

IS - 19

ER -

Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants

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