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Clinical Trial
. 2018 Dec 18;36(52):7943-7949.
doi: 10.1016/j.vaccine.2018.11.006. Epub 2018 Nov 9.

A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

Niraj Rathi  1 , Sajjad Desai  2 , Anand Kawade  3 , Padmasani Venkatramanan  4 , Ritabrata Kundu  5 , Sanjay K Lalwani  6 , A P Dubey  7 , J Venkateswara Rao  8 , D Narayanappa  9 , Radha Ghildiyal  10 , Nithya Gogtay  11 , P Venugopal  12 , Sonali Palkar  6 , Renuka Munshi  10 , Gagandeep Kang  13 , Sudhir Babji  13 , Ashish Bavdekar  3 , Sanjay Juvekar  3 , Nupur Ganguly  5 , Prabal Niyogi  5 , Kheya Ghosh Uttam  5 , H S Rajani  9 , Alpana Kondekar  10 , Dipti Kumbhar  10 , Smilu Mohanlal  10 , Mukesh C Agarwal  11 , Parvan Shetty  11 , Kalpana Antony  1 , Bhagwat Gunale  2 , Abhijeet Dharmadhikari  2 , Yuxiao Tang  14 , Prasad S Kulkarni  15 , Jorge Flores  14
Affiliations
Clinical Trial

A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

Niraj Rathi et al. Vaccine. .

Abstract

Background: A heat-stable bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was developed in India. In this study, the vaccine was tested for safety, immunogenicity and clinical lot-to-lot consistency.

Methods: This was a Phase III, open label, randomized, equivalence design study. The primary objective was to demonstrate lot-to-lot consistency of BRV-PV. Subjects were randomized into four arms, three arms received Lots A, B, and C of BRV-PV and the control arm, received Rotarix®. Three doses of BRV-PV or two doses of Rotarix® and one dose of placebo 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. The three lots of BRV-PV were equivalent if the 95% Confidence Intervals (CIs) of the geometric mean concentration (GMC) ratios were between 0.5 and 2. Solicited reactions were collected by using diary cards.

Results: The study was conducted in 1500 randomized infants, of which 1341 infants completed the study. The IgA GMC ratios among the three lots were around 1 (Lot A versus Lot B: 1.07; Lot A versus Lot C: 1.06; and Lot B versus Lot C: 0.99). The 95% CIs for the GMC ratios were between 0.78 and 1.36. The IgA GMCs were: BRV-PV group 19.16 (95% CI 17.37-21.14) and Rotarix® group 10.92 (95% CI 9.36-12.74) (GMC ratio 1.75; 90% CI 1.51-2.04). Seropositivity rates were 46.98% (95% CI 43.86-50.11) and 31.12% (95% CI 26.17-36.41). The incidence of solicited reactions was comparable across the four arms. No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups.

Conclusion: Lot-to-lot consistency of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies. The vaccine safety and immunogenicity profiles were similar to those of Rotarix®. Clinical Trials.Gov [NCT02584816] and Clinical Trial Registry of India [CTRI/2015/07/006034].

Keywords: Bovine-Human Reassortant Pentavalent Rotavirus Vaccine (BRV-PV); Immunogenicity; Lot-to-Lot Consistency; Safety.

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Figures

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Study flowchart.
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References

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