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

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

doi:10.1016/j.vaccine.2019.03.067

Cited by 16 publications

(8 citation statements)

References 17 publications

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“…Our approach to determine non-inferiority of ROTAVAC 5D with respect to ROTAVAC applied robust statistical methodology by establishing an a priori threshold GMC ratio between the two vaccines of > 0.5 to demonstrate immunologic non-inferiority of the former to the latter. These criteria have been used previously in comparing other rotavirus formulations [15] .…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Chilengi

Mwila-Kazimbaya

Chirwa

et al. 2021

Vaccine

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Background and Aims ROTAVAC® (frozen formulation stored at −20 °C) and ROTAVAC 5D® (liquid formulation stable at 2–8 °C) are rotavirus vaccines derived from the 116E human neonatal rotavirus strain, developed and licensed in India. This study evaluated and compared the safety and immunogenicity of these vaccines in an infant population in Zambia. Methods We conducted a phase 2b, open-label, randomized, controlled trial wherein 450 infants 6 to 8 weeks of age were randomized equally to receive three doses of ROTAVAC or ROTAVAC 5D, or two doses of ROTARIX®. Study vaccines were administered concomitantly with routine immunizations. Blood samples were collected pre-vaccination and 28 days after the last dose. Serum anti-rotavirus IgA antibodies were measured by ELISA, with WC3 and 89–12 rotavirus strains as viral lysates in the assays. The primary analysis was to assess non-inferiority of ROTAVAC 5D to ROTAVAC in terms of the geometric mean concentration (GMC) of serum IgA (WC3) antibodies. Seroresponse and seropositivity were also determined. Safety was evaluated as occurrence of immediate, solicited, unsolicited, and serious adverse events after each dose. Results The study evaluated 388 infants in the per-protocol population. All three vaccines were well tolerated and immunogenic. The post-vaccination GMCs were 14.0 U/mL (95% CI: 10.4, 18.8) and 18.1 U/mL (95% CI: 13.7, 24.0) for the ROTAVAC and ROTAVAC 5D groups, respectively, yielding a ratio of 1.3 (95% CI: 0.9, 1.9), thus meeting the pre-set non-inferiority criteria. Solicited and unsolicited adverse events were similar across all study arms. No death or intussusception case was reported during study period. Conclusions Among Zambian infants, both ROTAVAC and ROTAVAC 5D were well tolerated and the immunogenicity of ROTAVAC 5D was non-inferior to that of ROTAVAC. These results are consistent with those observed in licensure trials in India and support use of these vaccines across wider geographical areas.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Chilengi

Mwila-Kazimbaya

Chirwa

et al. 2021

Vaccine

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“…Each vaccine, kept between 2 and 8 • C, contained ≥10 5.6 FFU each of G1, G2, G3, G4, and G9 serotypes per dose of 2.0 mL administered at 6, 10, and 14 weeks of age. The GMC of anti-rotavirus IgA was 36.35% for LR vs. 30.51% for PR (GMC ratio = 1.19), the seropositivity ≥20 U/mL was 60.41% for LR vs. 52.75% for PR (GMC ratio = 7.66), and the GMC ratio of anti-rotavirus IgA among the three lots was 1.34 for lot A vs. B, 1.22 for lot A vs. C, and 0.91 for lot B vs. C [356]. Non-inferiority of the LR to PR was proven because the GMC ratio was >0.5, and the lot-to-lot consistency was also established because the GMC ratios were within 0.5-2.0 [356].…”

Section: Live-attenuated Oral Rotavirus Vaccines Require Cold Storage Facility and Transportationmentioning

confidence: 95%

“…The GMC of anti-rotavirus IgA was 36.35% for LR vs. 30.51% for PR (GMC ratio = 1.19), the seropositivity ≥20 U/mL was 60.41% for LR vs. 52.75% for PR (GMC ratio = 7.66), and the GMC ratio of anti-rotavirus IgA among the three lots was 1.34 for lot A vs. B, 1.22 for lot A vs. C, and 0.91 for lot B vs. C [356]. Non-inferiority of the LR to PR was proven because the GMC ratio was >0.5, and the lot-to-lot consistency was also established because the GMC ratios were within 0.5-2.0 [356]. The vaccine lots showed no interference with other childhood vaccines and were well-tolerated without any related associated adverse events.…”

Section: Live-attenuated Oral Rotavirus Vaccines Require Cold Storage Facility and Transportationmentioning

confidence: 95%

Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines

Folorunso

Sebolai

2020

Vaccines

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Safety, efficacy, and cost-effectiveness are paramount to vaccine development. Following the isolation of rotavirus particles in 1969 and its evidence as an aetiology of severe dehydrating diarrhoea in infants and young children worldwide, the quest to find not only an acceptable and reliable but cost-effective vaccine has continued until now. Four live-attenuated oral rotavirus vaccines (LAORoVs) (Rotarix®, RotaTeq®, Rotavac®, and RotaSIIL®) have been developed and licensed to be used against all forms of rotavirus-associated infection. The efficacy of these vaccines is more obvious in the high-income countries (HIC) compared with the low- to middle-income countries (LMICs); however, the impact is far exceeding in the low-income countries (LICs). Despite the rotavirus vaccine efficacy and effectiveness, more than 90 countries (mostly Asia, America, and Europe) are yet to implement any of these vaccines. Implementation of these vaccines has continued to suffer a setback in these countries due to the vaccine cost, policy, discharging of strategic preventive measures, and infrastructures. This review reappraises the impacts and effectiveness of the current live-attenuated oral rotavirus vaccines from many representative countries of the globe. It examines the problems associated with the low efficacy of these vaccines and the way forward. Lastly, forefront efforts put forward to develop initial procedures for oral rotavirus vaccines were examined and re-connected to today vaccines.

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“…70 The incidence of adverse events was similar across all four study arms. 53 There was only one vaccine-related serious adverse event of gastroenteritis in the ROTASIIL group. 53 The liquid formulation was found to be non-inferior from an immunologic and safety perspective compared to the lyophilized formulation, and the study demonstrated lot-to-lot consistency.…”

Section: New Presentationsmentioning

confidence: 92%

Product review of the rotavirus vaccines ROTASIIL, ROTAVAC, and Rotavin-M1

Skansberg

Sauer

Tan

et al. 2020

Human Vaccines & Immunotherapeutics

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Rotavirus is the leading cause of severe dehydrating gastroenteritis and death due to diarrhea among children under 5, causing over 180,000 under-5 deaths annually. Safe, effective rotavirus vaccines have been available for over a decade and are used in over 98 countries. In addition to the globally available, WHO-prequalified ROTARIX (GSK) and RotaTeq (Merck), several new rotavirus vaccines have attained national licensure -ROTAVAC (Bharat Biotech) and ROTASIIL (Serum Institute of India), licensed and manufactured in India and now WHO-prequalified, and Rotavin-M1 (PolyVac), licensed and manufactured in Vietnam. In this review, we summarize the available clinical trial and post-introduction evidence for these three new orally administered rotavirus vaccines. All three vaccines have demonstrated safety and efficacy against rotavirus diarrhea, although publicly available preclinical data are limited in some cases. This expanding product landscape presents a range of options to optimize immunization programs, and new presentations of each vaccine are currently under development.

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

Cited by 16 publications

References 17 publications

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants

Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines

Product review of the rotavirus vaccines ROTASIIL, ROTAVAC, and Rotavin-M1

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