A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

Kulkarni, Prasad S.; Desai, Sajjad; Tewari, Tushar; Kawade, Anand; Goyal, Nidhi; Bs, Garg; Kumar, Dinesh; Kanungo, Suman; Kamat, Veena; Kang, Gagandeep; Bavdekar, Ashish; Babji, Sudhir; Juvekar, Sanjay; Manna, Byomkesh; Dutta, Shanta; Angurana, Rama; Dewan, Deepika; Dharmadhikari, Abhijeet; Zade, Jagdish K.; Dhere, Rajeev; Fix, Alan; Power, Maureen; Uprety, Vidyasagar; Parulekar, Varsha; Cho, Iksung; Chandola, Temsunaro Rongsen; Kedia, Vikash K.; Raut, Abhishek; Flores, Jorge; Shaikh, Hanif; Gupta, Lalit; Patil, Rakesh; Aslam, Mohd; Arya, Alok; Rafiqi, Farhana; Gupta, Subodh S; Maliye, Chetna; Bahulekar, Pramod; Bala, Kiran; Shora, Tajali Nazir; Hussain, Shahid; Bhattacharya, Mihir; Mukhopadhyay, Ashis K.; Pal, Dilip Kumar; Saha, Jayanta; Shetty, Ranjitha S; Kulkarni, Muralidhar M; Raj, Chythra V.

doi:10.1016/j.vaccine.2017.09.014

Cited by 107 publications

(110 citation statements)

References 34 publications

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“…For the last many years, vaccines against diphtheria, pertussis, tetanus, hepatitis B, haemophilus influenzae type b, and polio have also been given at these time points. As per regulatory requirements, it has to be demonstrated that any new vaccine does not interfere with the immune responses to these vaccines [7] .…”

Section: Introductionmentioning

confidence: 99%

Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine

Desai

Rathi

Kawade³

et al. 2018

Vaccine

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Background A newly developed bovine-human reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was tested for its potential effect on the immunogenicity of concomitantly administered EPI vaccines in infants in a randomized controlled study in India. Methods In this Phase III, multicenter, open label, randomized, controlled study, three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given to healthy infants at 6, 10, and 14 weeks of age. Subjects also received three doses of DTwP-HepB-Hib (diphtheria, tetanus, whole-cell pertussis, hepatitis B, and haemophilus influenzae type b conjugate – pentavalent vaccine) and oral polio vaccine concomitantly at 6, 10, and 14 weeks of age and a single dose of inactivated polio vaccine at 14 weeks of age. Blood samples were collected four weeks after the final vaccination to assess immune responses to all the vaccines administered. For diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 antibodies, non-interference was to be supported if the lower limit of the two-sided 90% confidence interval (CI) for the seroprotection rate difference for the BRV-PV group minus the Rotarix® group was >10.0%. For pertussis antibodies, non-interference was to be supported if the lower limit of the two-sided 90% CI for the ratio of geometric mean concentrations (GMCs) was >0.5. Results A total of 1500 infants were randomized to either BRV-PV (1125 infants) or Rotarix® (375 infants), of which 1341 completed the study as per the protocol. More than 97% of subjects achieved seroprotective antibody titres against diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 in both groups. The difference in seroprotection rates between the BRV-PV group and the Rotarix® group for all these antibodies was less than 1%. The ratio of GMCs of anti-pertussis IgG concentrations for the BRV-PV group versus Rotarix® was 1.04 [90% CI: 0.90; 1.19]. Conclusion BRV-PV does not interfere with the immunogenicity of concomitantly administered routine infants vaccines.

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Section: Introductionmentioning

confidence: 99%

Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine

Desai

Rathi

Kawade³

et al. 2018

Vaccine

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“…Therefore, the VP4 and VP7 reassortants generated here may be useful for the generation of vaccines based on strains circulating in Africa. Recently, two additional rotavirus vaccines (Rotavac and Rotasiil) have been developed in India [55,56]. Rotavac is based on strain 116E, which is a naturally-occurring G9P [11] human reassortant with bovine VP4 and was originally isolated from neonates with asymptomatic infection in India [57].…”

Section: Discussionmentioning

confidence: 99%

Generation of Simian Rotavirus Reassortants with VP4- and VP7-Encoding Genome Segments from Human Strains Circulating in Africa Using Reverse Genetics

Falkenhagen

Patzina-Mehling

Gadicherla

et al. 2020

Viruses

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Human rotavirus A (RVA) causes acute gastroenteritis in infants and young children. The broad use of two vaccines, which are based on RVA strains from Europe and North America, significantly reduced rotavirus disease burden worldwide. However, a lower vaccine effectiveness is recorded in some regions of the world, such as sub-Saharan Africa, where diverse RVA strains are circulating. Here, a plasmid-based reverse genetics system was used to generate simian RVA reassortants with VP4 and VP7 proteins derived from African human RVA strains not previously adapted to cell culture. We were able to rescue 1/3 VP4 mono-reassortants, 3/3 VP7 mono-reassortants, but no VP4/VP7 double reassortant. Electron microscopy showed typical triple-layered virus particles for the rescued reassortants. All reassortants stably replicated in MA-104 cells; however, the VP4 reassortant showed significantly slower growth compared to the simian RVA or the VP7 reassortants. The results indicate that, at least in cell culture, human VP7 has a high reassortment potential, while reassortment of human VP4 from unadapted human RVA strains with simian RVA seems to be limited. The characterized reassortants may be useful for future studies investigating replication and reassortment requirements of rotaviruses as well as for the development of next generation rotavirus vaccines.

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“…ROTASIIL, developed by the Serum Institute of India, is a bovine/human reassortant vaccine. It comprises the G6P [5] bovine rotavirus as a backbone, with the VP7 genes from human rotavirus strains incorporated to produce reassortant strains [10]. The vaccine received national licensure in India by the DCGI in 2016, and is awaiting WHO prequalification.…”

Section: Rotavirus Vaccinesmentioning

confidence: 99%

Update on vaccines for enteric pathogens

Riddle

Chen

Kirkwood

et al. 2018

Clinical Microbiology and Infection

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A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

Cited by 107 publications

References 34 publications

Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine

Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine

Generation of Simian Rotavirus Reassortants with VP4- and VP7-Encoding Genome Segments from Human Strains Circulating in Africa Using Reverse Genetics

Update on vaccines for enteric pathogens

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