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Vaccine May 2009The live attenuated strains used in the oral poliovirus (OPV) have been the main tool in the WHO polio eradication programme. However, these strains replicate in the... (Review)
Review
The live attenuated strains used in the oral poliovirus (OPV) have been the main tool in the WHO polio eradication programme. However, these strains replicate in the human gut and are excreted for several weeks after immunisation. During this period, the attenuating mutations in the vaccine strains can rapidly revert. This may, in rare cases, cause vaccine-associated paralytic poliomyelitis (VAPP) in vaccinees or result in transmissible and neurovirulent circulating vaccine-derived poliovirus (cVDPV) strains. Outbreaks of poliomyelitis caused by VDPV have recently occurred in communities with long-term incomplete immunisation coverage. Hypogammaglobulinaemic vaccinees can chronically excrete immunodeficient VDPV (iVDPV) for several decades. As long as OPV is used, cVDPV and iVDPV pose a risk of causing poliomyelitis in unprotected individuals and threaten the goal of poliovirus eradication. VDPV cannot arise from the inactivated poliovirus vaccine (IPV), but financial and logistical barriers to replace OPV with IPV remain.
Topics: Cross Infection; Disease Outbreaks; Humans; Mutation; Poliomyelitis; Poliovirus; Poliovirus Vaccines; Vaccines, Attenuated
PubMed: 19428874
DOI: 10.1016/j.vaccine.2009.02.071 -
Biologicals : Journal of the... Nov 2016The Global Polio Eradication Initiative (GPEI) has seen significant progress since it began in 1988, largely due to the worldwide use of oral poliovirus vaccine (OPV).... (Review)
Review
The Global Polio Eradication Initiative (GPEI) has seen significant progress since it began in 1988, largely due to the worldwide use of oral poliovirus vaccine (OPV). In order to achieve polio eradication the global cessation of OPV is necessary because OPV contains live attenuated poliovirus, which in rare circumstances could re-gain wild poliovirus (WPV) characteristics with potential to establish transmission. The GPEI endgame strategy for the period 2013-2018 recommends the globally synchronised sequential cessation of the Sabin strains contained in the OPV, starting with type 2 Sabin. The withdrawal of Sabin type 2 took place in April 2016, with the introduction of at least one dose of inactivated poliovirus vaccine (IPV) as a risk mitigation strategy. The introduction of IPV into 126 countries since 2013 has required a rapid scale-up of IPV production by the two manufacturers supplying the global public sector market. This scale-up has been fraught with challenges, resulting in reductions of 40-50% of initial supply commitments. Consequently, 22 countries will not be supplied until 2018, and another 23 countries will experience serious stock-outs. In the last decade repeated calls-for-action were made to the global community to invigorate their vision and investment in developing "new poliovirus vaccines" including the development of IPV from less-virulent strains, such as Sabin-IPV (S-IPV). The conventional Salk-IPV production is limited to high-income industrialized-country manufacturers due to the containment requirements (i.e., high sanitation, low force-of-poliovirus-infection, and high population immunity). The use of Sabin strains in the production of S-IPV carries a lower biosafety risk, and was determined to be suitable for production in developing countries, expanding the manufacturing base and making IPV more affordable and accessible in the long term. Significant progress in the S-IPV has been made since 2006. S-IPV is now licensed as S-IPV in Japan and as standalone S-IPV in China, demonstrating the feasibility of this vaccine. In addition, production process improvements can further reduce the cost of production. The latter are critical to the economic success of this vaccine in the global market. We summarize the progress made to date in S-IPV technology, the scientific data and economic evidence in support of S-IPV development.
Topics: Humans; Poliovirus; Poliovirus Vaccines; Vaccines, Attenuated
PubMed: 27720268
DOI: 10.1016/j.biologicals.2016.08.005 -
Lancet (London, England) Nov 2016
Topics: Antibodies, Viral; Humans; Immunization Schedule; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Poliovirus Vaccines
PubMed: 27871742
DOI: 10.1016/S0140-6736(16)32177-8 -
Globalization and Health Jul 2020The World Health Organisation Western Pacific Region countries were declared free of polio in 2000 until a polio outbreak involving 305 cases occurred in Indonesia in...
The World Health Organisation Western Pacific Region countries were declared free of polio in 2000 until a polio outbreak involving 305 cases occurred in Indonesia in 2006. It was not until 2014 that the World Health Organisation South East Asia region was officially declared polio-free again. However, in February 2019, the Global Polio Eradication Initiative announced a new circulating vaccine-derived poliovirus outbreak in the Papua province of Indonesia. To make matter worse, the outbreak responses were tardy and led to transmission among migrating communities to other cities. The pressing regional issues of polio outbreak caused by circulating vaccine-derived poliovirus and use of oral polio vaccine have not been well presented. Our letter highlighted the suboptimal outbreak responses as well as the necessity of cross-border vaccination to curb continued poliovirus transmission.
Topics: Disease Eradication; Disease Outbreaks; Global Health; Humans; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Vaccination; World Health Organization
PubMed: 32677974
DOI: 10.1186/s12992-020-00594-z -
MBio Nov 2018As oral poliovirus vaccine (OPV) causes vaccine-associated paralytic poliomyelitis, the polio endgame strategy introduced by the Global Polio Eradication Initiative...
As oral poliovirus vaccine (OPV) causes vaccine-associated paralytic poliomyelitis, the polio endgame strategy introduced by the Global Polio Eradication Initiative calls for a phased withdrawal of OPV and an introduction of inactivated poliovirus vaccine (IPV). The introduction of IPV creates challenges in maintaining the cold chain for vaccine storage and distribution. Recent advances in lyophilization have helped in finding a temperature-stable formulation for multiple vaccines; however, poliovirus vaccines have yet to capture a stable, safe formula for lyophilization. In addition, efficient methods for antigen measurement are needed for screening stable vaccine formulations. Here, we report size exclusion high-performance liquid chromatography (SE-HPLC) as a reliable means to identify the leading lyophilized formulation to generate thermostable Sabin inactivated poliovirus vaccine (sIPV). High-throughput screening and SE-HPLC determined the leading formulation, resulting in 95% D-antigen recovery and low residual moisture content of sIPV following lyophilization. Furthermore, the lyophilized sIPV remained stable after 4 weeks of incubation at ambient temperature and induced strong neutralizing antibodies and full protection of poliovirus receptor transgenic mice against the challenge of wild-type poliovirus. Overall, this report describes a novel means for the high-throughput evaluation of sIPV antigenicity and a thermostable lyophilized sIPV with vaccine potency. Poliomyelitis is a highly contagious disease caused by the poliovirus. While the live attenuated OPV has been the vaccine of choice, a major concern is its ability to revert to a form that can cause paralysis, so-called vaccine-associated paralytic poliomyelitis. Therefore, the new endgame strategy of the Global Polio Eradication Initiative includes the introduction of an IPV. However, the feasibility of the use of current IPV formulations in developing countries is limited, because IPV is insufficiently stable to be purified, transported, and stored under unrefrigerated conditions. We successfully designed the sIPV for use in the dry state that maintains the full vaccine potency in animal models after incubation at ambient temperature. This report provides, for the first time, candidate formulations of sIPV that are stable at elevated temperatures.
Topics: Animals; Chromatography, Gel; Chromatography, High Pressure Liquid; Disease Models, Animal; Drug Stability; Freeze Drying; Mice, Transgenic; Poliomyelitis; Poliovirus Vaccine, Inactivated; Technology, Pharmaceutical; Temperature
PubMed: 30482835
DOI: 10.1128/mBio.02287-18 -
Human Vaccines & Immunotherapeutics Feb 2021In 2000, China was declared polio-free. However, in 2018, wild poliovirus (WPV) was still endemic in two of its neighboring countries, making WPV importation and...
In 2000, China was declared polio-free. However, in 2018, wild poliovirus (WPV) was still endemic in two of its neighboring countries, making WPV importation and outbreak alarming possibilities. This study documents the seroprevalence of poliovirus antibodies before and after the polio vaccine switch in 2012 and 2017 in Beijing. Cross-sectional population-based serologic surveys were conducted in 2012 and 2017 in Beijing. The study subjects were selected from 10 different age groups (<1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-29, 30-34, 35-39, and ≥40 y) using a multi-stage-stratified sampling method. Neutralizing antibody titers against poliovirus serotypes 1 (P1), 2 (P2), and 3 (P3) were assayed by World Health Organization standards. The seropositive rates (SR) and geometric mean titer (GMT) of the neutralizing antibodies were 91.71% and 1:130.26, respectively, for P1, 94.09% and 1:113.39, respectively, for P2, and 88.78% and 1:79.65, respectively, for P3 before the switch in 2012, and 87.78% and 1:108.93, respectively, for P1, and 81.67% and 1:70.56, respectively, for P3 after the switch in 2017, with a statistically significant difference for P1 and P3 between 2012 and 2017. The neutralizing antibodies for all poliovirus serotypes differed among different age and vaccination groups in both 2012 and 2017. After switching polio vaccines twice in 2014 and 2016, the P1 and P3 polio antibody levels were lower in 2017 than in 2012. The P2 antibody levels were determined from the first dose of IPV. The seroprevalence of poliovirus antibodies after adjustment of the immunization schedule of the polio vaccine on January 1, 2020, must be further monitored.
Topics: Antibodies, Viral; Beijing; China; Cross-Sectional Studies; Humans; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Seroepidemiologic Studies; Vaccination
PubMed: 32703060
DOI: 10.1080/21645515.2020.1778409 -
Expert Review of Vaccines Feb 2009
Review
Topics: Humans; Poliomyelitis; Poliovirus Vaccines; Vaccines, Attenuated; Vaccines, Inactivated
PubMed: 19196189
DOI: 10.1586/14760584.8.2.127 -
Expert Review of Vaccines May 2011Following achievement of polio eradication, the routine use of all live-attenuated oral poliovirus vaccines should be discontinued. However, the costs per vaccine dose... (Review)
Review
Following achievement of polio eradication, the routine use of all live-attenuated oral poliovirus vaccines should be discontinued. However, the costs per vaccine dose for the alternative inactivated poliovirus vaccine (IPV) are significantly higher and the current production capacity is not sufficient for worldwide distribution of the vaccine. In order to achieve cost-prize reduction and improve affordability, IPV production processes and dose-sparing strategies should be developed to facilitate local manufacture at a relatively lower cost. The use of attenuated Sabin instead of wild-type polio strains will provide additional safety during vaccine production and permits production in low-cost settings. Sabin-IPV is under development by several manufacturers. This article gives an overview of results from clinical trials with Sabin-IPV and discusses the requirements and challenges in the clinical development of this novel IPV.
Topics: Biomedical Research; Clinical Trials as Topic; Humans; Poliomyelitis; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral
PubMed: 21604984
DOI: 10.1586/erv.11.51 -
The Journal of Infectious Diseases Dec 2005As polio eradication nears, the development of immunization policies for an era without the disease has become increasingly important. Outbreaks due to circulating...
BACKGROUND
As polio eradication nears, the development of immunization policies for an era without the disease has become increasingly important. Outbreaks due to circulating vaccine-derived poliovirus (VDPV) and rare cases of immunodeficient persons with prolonged VDPV shedding lend to the growing consensus that oral poliovirus vaccine (OPV) use should be discontinued as soon after polio eradication as possible. The present study was conducted to assess whether persons infected with human immunodeficiency virus (HIV) experience prolonged VDPV shedding and serve as a source of reintroduction of virus into the population.
METHODS
Adults infected with HIV had specimens tested (1) 8 months after a mass OPV campaign, to determine whether poliovirus related to OPV administered during the campaign was present (i.e., prolonged excretion), and (2) starting 7 weeks after a subsequent campaign, to determine whether poliovirus could be detected after the height of OPV exposure.
RESULTS
A total of 419 participants were enrolled--315 during the 8-12 months after an OPV campaign held in 2001 and 104 during the 7-13 weeks after a 2002 campaign. No poliovirus was isolated from any participants.
CONCLUSIONS
It appears unlikely that adults infected with HIV experience prolonged vaccine virus shedding, and, therefore, they probably represent a minimal risk of reintroducing vaccine virus into the population after poliovirus has been eradicated.
Topics: Adolescent; Adult; Aged; Cote d'Ivoire; Feces; Female; HIV Infections; Humans; Immunization Programs; Male; Middle Aged; Poliovirus; Poliovirus Vaccines; Virus Shedding
PubMed: 16288377
DOI: 10.1086/498166 -
Future Microbiology Dec 2016To estimate the incremental net benefits (INBs) of a hypothetical ideal vaccine with all of the advantages and no disadvantages of existing oral and inactivated...
AIM
To estimate the incremental net benefits (INBs) of a hypothetical ideal vaccine with all of the advantages and no disadvantages of existing oral and inactivated poliovirus vaccines compared with current vaccines available for future outbreak response.
METHODS
INB estimates based on expected costs and polio cases from an existing global model of long-term poliovirus risk management.
RESULTS
Excluding the development costs, an ideal poliovirus vaccine could offer expected INBs of US$1.6 billion. The ideal vaccine yields small benefits in most realizations of long-term risks, but great benefits in low-probability-high-consequence realizations.
CONCLUSION
New poliovirus vaccines may offer valuable insurance against long-term poliovirus risks and new vaccine development efforts should continue as the world gathers more evidence about polio endgame risks.
Topics: Humans; Models, Theoretical; Poliomyelitis; Poliovirus; Poliovirus Vaccines; Risk Management; Vaccination
PubMed: 27831742
DOI: 10.2217/fmb-2016-0126