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

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 labe...

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Autores principales: Desai, Sajjad, Rathi, Niraj, Kawade, Anand, Venkatramanan, Padmasani, Kundu, Ritabrata, Lalwani, Sanjay K., Dubey, A.P., Venkateswara Rao, J., Narayanappa, D., Ghildiyal, Radha, Gogtay, Nithya J, Venugopal, P., Palkar, Sonali, Munshi, Renuka, Bavdekar, Ashish, Juvekar, Sanjay, Ganguly, Nupur, Niyogi, Prabal, Uttam, Kheya Ghosh, Kondekar, Alpana, Kumbhar, Dipti, Mohanlal, Smilu, Agarwal, Mukesh C., Shetty, Parvan, Antony, Kalpana, Gunale, Bhagwat, Dharmadhikari, Abhijeet, Deshpande, Jagdish, Nalavade, Uma, Sharma, Deepa, Bansal, Anurag, Tang, Yuxiao, Flores, Jorge, Kulkarni, Prasad S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Science 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6143481/
https://www.ncbi.nlm.nih.gov/pubmed/30104114
http://dx.doi.org/10.1016/j.vaccine.2018.07.064
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author Desai, Sajjad
Rathi, Niraj
Kawade, Anand
Venkatramanan, Padmasani
Kundu, Ritabrata
Lalwani, Sanjay K.
Dubey, A.P.
Venkateswara Rao, J.
Narayanappa, D.
Ghildiyal, Radha
Gogtay, Nithya J
Venugopal, P.
Palkar, Sonali
Munshi, Renuka
Bavdekar, Ashish
Juvekar, Sanjay
Ganguly, Nupur
Niyogi, Prabal
Uttam, Kheya Ghosh
Kondekar, Alpana
Kumbhar, Dipti
Mohanlal, Smilu
Agarwal, Mukesh C.
Shetty, Parvan
Antony, Kalpana
Gunale, Bhagwat
Dharmadhikari, Abhijeet
Deshpande, Jagdish
Nalavade, Uma
Sharma, Deepa
Bansal, Anurag
Tang, Yuxiao
Flores, Jorge
Kulkarni, Prasad S.
author_facet Desai, Sajjad
Rathi, Niraj
Kawade, Anand
Venkatramanan, Padmasani
Kundu, Ritabrata
Lalwani, Sanjay K.
Dubey, A.P.
Venkateswara Rao, J.
Narayanappa, D.
Ghildiyal, Radha
Gogtay, Nithya J
Venugopal, P.
Palkar, Sonali
Munshi, Renuka
Bavdekar, Ashish
Juvekar, Sanjay
Ganguly, Nupur
Niyogi, Prabal
Uttam, Kheya Ghosh
Kondekar, Alpana
Kumbhar, Dipti
Mohanlal, Smilu
Agarwal, Mukesh C.
Shetty, Parvan
Antony, Kalpana
Gunale, Bhagwat
Dharmadhikari, Abhijeet
Deshpande, Jagdish
Nalavade, Uma
Sharma, Deepa
Bansal, Anurag
Tang, Yuxiao
Flores, Jorge
Kulkarni, Prasad S.
author_sort Desai, Sajjad
collection PubMed
description 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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spelling pubmed-61434812018-09-20 Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine() Desai, Sajjad Rathi, Niraj Kawade, Anand Venkatramanan, Padmasani Kundu, Ritabrata Lalwani, Sanjay K. Dubey, A.P. Venkateswara Rao, J. Narayanappa, D. Ghildiyal, Radha Gogtay, Nithya J Venugopal, P. Palkar, Sonali Munshi, Renuka Bavdekar, Ashish Juvekar, Sanjay Ganguly, Nupur Niyogi, Prabal Uttam, Kheya Ghosh Kondekar, Alpana Kumbhar, Dipti Mohanlal, Smilu Agarwal, Mukesh C. Shetty, Parvan Antony, Kalpana Gunale, Bhagwat Dharmadhikari, Abhijeet Deshpande, Jagdish Nalavade, Uma Sharma, Deepa Bansal, Anurag Tang, Yuxiao Flores, Jorge Kulkarni, Prasad S. Vaccine Article 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. Elsevier Science 2018-09-05 /pmc/articles/PMC6143481/ /pubmed/30104114 http://dx.doi.org/10.1016/j.vaccine.2018.07.064 Text en © 2018 The Authors. Published by Elsevier Ltd. http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Desai, Sajjad
Rathi, Niraj
Kawade, Anand
Venkatramanan, Padmasani
Kundu, Ritabrata
Lalwani, Sanjay K.
Dubey, A.P.
Venkateswara Rao, J.
Narayanappa, D.
Ghildiyal, Radha
Gogtay, Nithya J
Venugopal, P.
Palkar, Sonali
Munshi, Renuka
Bavdekar, Ashish
Juvekar, Sanjay
Ganguly, Nupur
Niyogi, Prabal
Uttam, Kheya Ghosh
Kondekar, Alpana
Kumbhar, Dipti
Mohanlal, Smilu
Agarwal, Mukesh C.
Shetty, Parvan
Antony, Kalpana
Gunale, Bhagwat
Dharmadhikari, Abhijeet
Deshpande, Jagdish
Nalavade, Uma
Sharma, Deepa
Bansal, Anurag
Tang, Yuxiao
Flores, Jorge
Kulkarni, Prasad S.
Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine()
title Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine()
title_full Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine()
title_fullStr Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine()
title_full_unstemmed Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine()
title_short Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine()
title_sort non-interference of bovine-human reassortant pentavalent rotavirus vaccine rotasiil® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine()
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6143481/
https://www.ncbi.nlm.nih.gov/pubmed/30104114
http://dx.doi.org/10.1016/j.vaccine.2018.07.064
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