Cargando…
Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial
BACKGROUND: The final endgame strategy of global polio eradication initiative includes switching from trivalent oral poliovirus vaccines (tOPV) to bivalent oral polio vaccine (bOPV), and introduction of inactivated poliovirus vaccine (IPV). This study compares IPV with tOPV week 39 boost in Indian i...
Autores principales: | , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5289926/ https://www.ncbi.nlm.nih.gov/pubmed/28194449 http://dx.doi.org/10.1016/j.heliyon.2016.e00223 |
_version_ | 1782504559078277120 |
---|---|
author | Kanungo, Suman Kim, Deok Ryun Haldar, Bisakha Snider, Cynthia Nalavade, Uma Kim, Soon Ae Park, Ju Yeon Sinha, Anuradha Mallick, Aiyel Haque Manna, Byomkesh Sur, Dipika Nandy, Ranjan Kumar Deshpande, Jagadish M. Czerkinsky, Cecil Wierzba, Thomas F Jr., William A Petri Ali, Mohammad Dey, Ayan |
author_facet | Kanungo, Suman Kim, Deok Ryun Haldar, Bisakha Snider, Cynthia Nalavade, Uma Kim, Soon Ae Park, Ju Yeon Sinha, Anuradha Mallick, Aiyel Haque Manna, Byomkesh Sur, Dipika Nandy, Ranjan Kumar Deshpande, Jagadish M. Czerkinsky, Cecil Wierzba, Thomas F Jr., William A Petri Ali, Mohammad Dey, Ayan |
author_sort | Kanungo, Suman |
collection | PubMed |
description | BACKGROUND: The final endgame strategy of global polio eradication initiative includes switching from trivalent oral poliovirus vaccines (tOPV) to bivalent oral polio vaccine (bOPV), and introduction of inactivated poliovirus vaccine (IPV). This study compares IPV with tOPV week 39 boost in Indian infants. METHODS: Starting 28 March 2012, we enrolled 372 Indian infant-mother pairs from Kolkata, India in an open-label, block-randomized, controlled trial comparing a 39 week tOPV to an IPV boost among infants immunized with three doses of tOPV. The primary outcome was mucosal immunity to poliovirus as measured by fecal polio virus shedding after OPV challenge. The secondary outcome was humoral response as defined by >1:8 titers for neutralizing antibodies at week 40. Seroconversion was measured by change in level of antibody titers from week 18 to week 40. The analyses were performed by both intention-to-treat (ITT) and per-protocol (PP) comparing the occurrences of outcomes between the arms of the study. FINDINGS: Both the study arms provided equivalent mucosal immunity at 52 weeks with a total shedding prevalence of 28%. Vaccination with IPV resulted in significantly higher seroconversion rates for Polio type 2 (p = 0.03) and Polio type 3 (p < 0.01). CONCLUSIONS: This study indicates that an IPV boost at week 39 is equivalent to tOPV in intestinal immunity, and provides higher seroconversion compared to tOPV. The major limitation of the study was the additional OPV doses receive by infants during pulse polio immunization resulted in additional mucosal boosting, diminishing the impact of IPV or tOPV boost at week 39. However, IPV for OPV boost should prove to be a step forward in the global polio eradication initiative to reduce the problem of circulating vaccine-derived poliovirus (cVDPV). |
format | Online Article Text |
id | pubmed-5289926 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-52899262017-02-13 Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial Kanungo, Suman Kim, Deok Ryun Haldar, Bisakha Snider, Cynthia Nalavade, Uma Kim, Soon Ae Park, Ju Yeon Sinha, Anuradha Mallick, Aiyel Haque Manna, Byomkesh Sur, Dipika Nandy, Ranjan Kumar Deshpande, Jagadish M. Czerkinsky, Cecil Wierzba, Thomas F Jr., William A Petri Ali, Mohammad Dey, Ayan Heliyon Article BACKGROUND: The final endgame strategy of global polio eradication initiative includes switching from trivalent oral poliovirus vaccines (tOPV) to bivalent oral polio vaccine (bOPV), and introduction of inactivated poliovirus vaccine (IPV). This study compares IPV with tOPV week 39 boost in Indian infants. METHODS: Starting 28 March 2012, we enrolled 372 Indian infant-mother pairs from Kolkata, India in an open-label, block-randomized, controlled trial comparing a 39 week tOPV to an IPV boost among infants immunized with three doses of tOPV. The primary outcome was mucosal immunity to poliovirus as measured by fecal polio virus shedding after OPV challenge. The secondary outcome was humoral response as defined by >1:8 titers for neutralizing antibodies at week 40. Seroconversion was measured by change in level of antibody titers from week 18 to week 40. The analyses were performed by both intention-to-treat (ITT) and per-protocol (PP) comparing the occurrences of outcomes between the arms of the study. FINDINGS: Both the study arms provided equivalent mucosal immunity at 52 weeks with a total shedding prevalence of 28%. Vaccination with IPV resulted in significantly higher seroconversion rates for Polio type 2 (p = 0.03) and Polio type 3 (p < 0.01). CONCLUSIONS: This study indicates that an IPV boost at week 39 is equivalent to tOPV in intestinal immunity, and provides higher seroconversion compared to tOPV. The major limitation of the study was the additional OPV doses receive by infants during pulse polio immunization resulted in additional mucosal boosting, diminishing the impact of IPV or tOPV boost at week 39. However, IPV for OPV boost should prove to be a step forward in the global polio eradication initiative to reduce the problem of circulating vaccine-derived poliovirus (cVDPV). Elsevier 2017-01-09 /pmc/articles/PMC5289926/ /pubmed/28194449 http://dx.doi.org/10.1016/j.heliyon.2016.e00223 Text en © 2017 The Authors 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 Kanungo, Suman Kim, Deok Ryun Haldar, Bisakha Snider, Cynthia Nalavade, Uma Kim, Soon Ae Park, Ju Yeon Sinha, Anuradha Mallick, Aiyel Haque Manna, Byomkesh Sur, Dipika Nandy, Ranjan Kumar Deshpande, Jagadish M. Czerkinsky, Cecil Wierzba, Thomas F Jr., William A Petri Ali, Mohammad Dey, Ayan Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial |
title | Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial |
title_full | Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial |
title_fullStr | Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial |
title_full_unstemmed | Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial |
title_short | Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial |
title_sort | comparison of ipv to topv week 39 boost of primary opv vaccination in indian infants: an open labelled randomized controlled trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5289926/ https://www.ncbi.nlm.nih.gov/pubmed/28194449 http://dx.doi.org/10.1016/j.heliyon.2016.e00223 |
work_keys_str_mv | AT kanungosuman comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT kimdeokryun comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT haldarbisakha comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT snidercynthia comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT nalavadeuma comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT kimsoonae comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT parkjuyeon comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT sinhaanuradha comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT mallickaiyelhaque comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT mannabyomkesh comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT surdipika comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT nandyranjankumar comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT deshpandejagadishm comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT czerkinskycecil comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT wierzbathomasf comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT jrwilliamapetri comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT alimohammad comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial AT deyayan comparisonofipvtotopvweek39boostofprimaryopvvaccinationinindianinfantsanopenlabelledrandomizedcontrolledtrial |