Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL®)

Naik, Sameer P.; Zade, Jagdish K.; Sabale, Rajendra N.; Pisal, Sambhaji S.; Menon, Ravi; Bankar, Subhash G.; Gairola, Sunil; Dhere, Rajeev

doi:10.1016/j.vaccine.2017.04.025

Cited by 50 publications

(36 citation statements)

References 15 publications

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“…There is only one available published study on this vaccine that includes evaluations of different virus concentrations and doses in a phase I adult-infant and phase II infant trials 34 . Rotasiil® is a UK bovine reassortant vaccine composed of five reassorted strains, with the added benefit of heat stability, developed in partnership with researchers from the USA, India, and Brazil 35 . In Nigerien children, three doses had an efficacy of 67% against severe rotavirus gastroenteritis 36 .…”

Section: Rotavirus Vaccinesmentioning

confidence: 99%

Rotavirus Vaccines: a story of success with challenges ahead

O’Ryan

2017

F1000Res

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Approximately 40 years have passed since the discovery of the rotavirus and 10 years since the introduction and progressive dissemination of rotavirus vaccines worldwide. Currently, 92 countries have introduced rotavirus vaccines into national or subnational programs with evident impact in disease reduction. Two vaccines have been widely used, and four additional vaccines have been licensed and are being used in defined regions. In this context, one main issue that remains unsolved is the lower vaccine efficacy/effectiveness in low-income countries. An additional partially answered issue relates to rotavirus strain circulation in vaccinated populations. These issues are discussed in this review. The most imperative challenge ahead is to fulfill the WHO’s recommendation to introduce rotavirus vaccines in all countries.

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Section: Rotavirus Vaccinesmentioning

confidence: 99%

Rotavirus Vaccines: a story of success with challenges ahead

O’Ryan

2017

F1000Res

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“…As a consequence, rotavirus surveillance studies became meaningful to build vaccine development strategies 10 . Commonly used two licensed vaccines i.e., Rotataq (monovalent), Rotarix (pentavalent) and other vaccines in China, India, and Vietnam have been implemented [11][12][13][14] . However, even after implementation of Rotarix in the national immunization schedule, G1P [8] became dominant genotype (52%) followed by G2P [4].…”

Section: Introductionmentioning

confidence: 99%

Multi valent DNA vaccine against group A human rotavirus: anin-silicoinvestigation

Dutta

2020

Preprint

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Gastroenteritis due to single rotavirus causes huge economic loss annually.Severity of rotaviral diarrhoea among children is primarily manifested by different combinations of G and P types. Rotavirus surveillance studies resulted in two ambitious globally licensed vaccine namely, Rotarix and RotaTaq and a few other.However, post-vaccination surveillance studies indicate, vaccine failure and other complications such as intussusception, environmental enteric dysfunction, etc.Herein, we design a multivalent DNA vaccine against rotavirus and tested its efficiency by using in silico tools. Two main neutralizing rotaviral antigens i.e, VP7 and VP8 were taken into account and respectively 390, 450 known sequences of different serogroup have been analyzed to obtain a consensus sequence for epitope prediction. Epitopes specific for MHC-I and -II were predicted using IEDB and chosen based on their best IC 50 value and CPR. A good binding profile with a monoclonal antibody specific for B-cell antigens is displayed by all epitopes they were found to be non-allergenic in the human host. Ethnic specificity of the epitopes is also within acceptable range except for South African and Central American populations. We use pBI-CMV1 bidirectional mammalian expression vector to design the DNA vaccine, where we stapled manually integrated epitopes for VP7 and VP8 at MCS1 and 2 respectively. In conclusion, this study provides a new set of data for a new DNA vaccine against rotavirus.

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“…39 HSRV04D5 also has improved stability compared to lyophilized Rotarix® (stable for 36 months 2–8°C and 7 days at 37°C), and Rotavac (storage at -20°C and 6 months at 5°C ± 3°C) while it is comparable to ROTASIIL® (stable for 36 months at 2–8°C and 25°C and 18 months at 40°C). 40 …”

Section: Discussionmentioning

confidence: 99%

Rational design of heat stable lyophilized rotavirus vaccine formulations

Madhu

Sikriwal

Sharma

et al. 2018

Human Vaccines & Immunotherapeutics

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To develop a safe and efficacious heat-stable rotavirus vaccine, new lyophilized formulations were developed using rotavirus serotypes constituting RotaTeq®. A series of formulation compositions, differing in buffering agents, bulking agents, cryoprotectants, amino acids and divalent cations, were screened for their ability to provide stability to rotavirus serotypes during lyophilization and when stored under elevated temperatures for extended periods. Lead formulations and lyophilization cycles were further optimized. Stability profiles of thus optimized formulations showed their ability to retain the potency of rotavirus for > 36 months at 5°C, 20 months at 37°C, and 7 months at 45°C. The heat-stable lyophilized rotavirus formulations developed met the all critical quality attributes for appearance, heat-stability during storage, moisture content as well as pH, viability and stability after reconstitution and has great potential to be used as vaccine candidates for improving access in low-income countries.

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Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL®)

Cited by 50 publications

References 15 publications

Rotavirus Vaccines: a story of success with challenges ahead

Rotavirus Vaccines: a story of success with challenges ahead

Multi valent DNA vaccine against group A human rotavirus: anin-silicoinvestigation

Rational design of heat stable lyophilized rotavirus vaccine formulations

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