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Abstract
Environmental surveillance was recommended for risk mitigation in a novel oral polio vaccine-2 (nOPV2) clinical trial (M5-ABMG) to monitor excretion, potential circulation, and loss of attenuation of the two nOPV2 candidates. The nOPV2 candidates were developed to address the risk of poliovirus (PV) type 2 circulating vaccine-derived poliovirus (cVDPV) as part of the global eradication strategy. Between November 2018 and January 2020, an environmental surveillance study for the clinical trial was conducted in parallel to the M5-ABMG clinical trial at five locations in Panama. The collection sites were located upstream from local treatment plant inlets, to capture the excreta from trial participants and their community. Laboratory analyses of 49 environmental samples were conducted using the two-phase separation method. Novel OPV2 strains were not detected in sewage samples collected during the study period. However, six samples were positive for Sabin-like type 3 PV, two samples were positive for Sabin-like type 1 PV, and non-polio enteroviruses NPEVs were detected in 27 samples. One of the nOPV2 candidates has been granted Emergency Use Listing by the World Health Organization and initial use started in March 2021. This environmental surveillance study provided valuable risk mitigation information to support the Emergency Use Listing application.
Highlights
The ES-M5 study was a risk assessment mitigation measure in the evaluation of the novel oral polio vaccine-2 (nOPV2) vaccine candidates administered as part of the M5-ABMG clinical trial in response to the unique context created by the confluence of wild type 2 PV eradication certification, OPV2 withdrawal, and World Health Organization (WHO) PV containment guidelines [8]
The risk mitigation information provided by the ES-M5 added a community safety component to the existing nOPV2 safety data
Sensitivity was demonstrated by detection of NPEV and Sabin-like polioviruses
Summary
Vaccination campaigns with oral polio vaccines (OPVs) have been a part of the global polio eradication initiative by the World Health Organization (WHO) since 1959. In 1974, the WHO formulated an Expanded Programme on Immunization to guide programs in developing countries and improve vaccination coverage. As a result of those programs, in 1990 approximately 80% of 1-year-old children had received three doses of OPV and the global morbidity and mortality associated with poliomyelitis decreased considerably [1]. In Panama the prevalence of polio is zero and the country is free from the disease. The last case of wild poliovirus type 2 in Panama was reported in 1971 and in 1972 there was a report of a non-determined wild poliovirus [2]
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