Evaluation of vaccine derived poliovirus type 2 outbreak response options: A randomized controlled trial, Karachi, Pakistan

Abstract

Background: Outbreaks of circulating vaccine derived polioviruses type 2 (cVDPV2) remain a risk to poliovirus eradication in an era without live poliovirus vaccine containing type 2 in routine immunization. We evaluated existing outbreak response strategies recommended by the World Health Organization (WHO) for control of cVDPV2 outbreaks.

Methods: Seronegative children for poliovirus type 2 (PV2) at 22 weeks of life were assigned to one of four study groups and received respectively (1) one dose of trivalent oral poliovirus vaccine (tOPV); (2) monovalent OPV 2 (mOPV2); (3) tOPV together with a dose of inactivated poliovirus vaccine (IPV); or (4) mOPV2 with monovalent high-potency IPV type 2. Stool and blood samples were collected and assessed for presence of PV2 (stool) and anti-polio antibodies (sera).

Results: We analyzed data from 265 children seronegative for PV2. Seroconversion to PV2 was achieved in 48, 76, 98 and 100% in Groups 1-4 respectively. mOPV2 was more immunogenic than tOPV alone (p < 0.001); and OPV in combination with IPV was more immunogenic than OPV alone (p < 0.001). There were 33%, 67%, 20% and 43% PV2 excretors in Groups 1-4 respectively. mOPV2 resulted in more prevalent shedding of PV2 than when tOPV was used (p < 0.001); and tOPV together with IPV resulted in lower excretion of PV2 than tOPV alone (p = 0.046).

Conclusion: mOPV2 was a more potent vaccine than tOPV. Adding IPV to OPV improved immunological response; adding IPV also seemed to have shortened the duration of PV2 shedding. mIPV2 did not provide measurable improvement of immune response when compared to conventional IPV. WHO recommendation to use mOPV2 as a vaccine of first choice in cVDPV2 outbreak response was supported by our findings. Clinical Trial registry number: NCT02189811.

Keywords: Polio outbreak response; Polio vaccines; Polio virus 2.

Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Figures

Fig. 1

Study consort chart [PV2 – Poliovirus type 2] [Group 1: tOPV, Group 2: mOPV 2, Group 3: tOPV+IPV, Group 4 mOPV 2+mIPV 2].

Fig. 2

Proportion of subjects who mounted an anamnestic response to poliovirus vaccine in PV2-seronegative children (measured as proportion of seroconvertors who responded to PV2 one week after vaccine administration and stratified by whether they had received prior IPV or not).

Fig. 3

Excretion of poliovirus type 2 in stool one week after OPV administration among seronegative children who were not excreting poliovirus type 2 at 22 weeks.