Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants

an open labelled randomized controlled trial

Suman Kanungo, Deok Ryun Kim, Bisakha Haldar, Cynthia Snider, Uma Nalavade, Soon Ae Kim, Ju Yeon Park, Anuradha Sinha, Aiyel Haque Mallick, Byomkesh Manna, Dipika Sur, Ranjan Kumar Nandy, Jagadish M. Deshpande, Cecil Czerkinsky, Thomas F. Wierzba, William A Petri Jr., Mohammad Ali, Ayan Dey

Research output: Contribution to journalArticle

Abstract

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).

Original languageEnglish (US)
Article numbere00223
JournalHeliyon
Volume3
Issue number1
DOIs
StatePublished - Jan 1 2017

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Inactivated Poliovirus Vaccine
Oral Poliovirus Vaccine
Poliomyelitis
Vaccination
Randomized Controlled Trials
Mucosal Immunity
Poliovirus Vaccines
Virus Shedding
Poliovirus
Neutralizing Antibodies
India
Immunity
Immunization
Vaccines
Mothers
Antibodies

Keywords

  • Health profession
  • Immunology
  • Infectious disease
  • Internal medicine
  • Pathology
  • Pediatrics
  • Pharmaceutical science
  • Public health

ASJC Scopus subject areas

  • General

Cite this

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.

In: Heliyon, Vol. 3, No. 1, e00223, 01.01.2017.

Research output: Contribution to journalArticle

Kanungo, S, Kim, DR, Haldar, B, Snider, C, Nalavade, U, Kim, SA, Park, JY, Sinha, A, Mallick, AH, Manna, B, Sur, D, Nandy, RK, Deshpande, JM, Czerkinsky, C, Wierzba, TF, Jr., WAP, Ali, M & Dey, A 2017, 'Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial', Heliyon, vol. 3, no. 1, e00223. https://doi.org/10.1016/j.heliyon.2016.e00223
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. In: Heliyon. 2017 ; Vol. 3, No. 1.
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abstract = "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).",
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T2 - an open labelled randomized controlled trial

AU - Kanungo, Suman

AU - Kim, Deok Ryun

AU - Haldar, Bisakha

AU - Snider, Cynthia

AU - Nalavade, Uma

AU - Kim, Soon Ae

AU - Park, Ju Yeon

AU - Sinha, Anuradha

AU - Mallick, Aiyel Haque

AU - Manna, Byomkesh

AU - Sur, Dipika

AU - Nandy, Ranjan Kumar

AU - Deshpande, Jagadish M.

AU - Czerkinsky, Cecil

AU - Wierzba, Thomas F.

AU - Jr., William A Petri

AU - Ali, Mohammad

AU - Dey, Ayan

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N2 - 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).

AB - 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).

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