-
Diagnostic Microbiology and Infectious... Jan 2006After exposure to the oral poliovirus vaccine (OPV), immunocompetent persons excrete poliovirus (PV) vaccine strains for a limited period. In contrast, immunodeficient...
After exposure to the oral poliovirus vaccine (OPV), immunocompetent persons excrete poliovirus (PV) vaccine strains for a limited period. In contrast, immunodeficient individuals remain sometimes chronically infected, and in some cases, PV excretion times as long as 10 years have been reported. During prolonged replication in the human intestine, the PV vaccine strain almost invariably reverts its attenuated character and acquires neurovirulent properties (vaccine-derived PVs, or VDPVs), which resemble wild-type PV strains. The aim of this study was to determine the occurrence of OPV strains in stools of immunodeficient children from a selected area in South Africa, as a first step toward future research on the prevalence and potential health impact of VDPVs. In a period of 1 year, a total of 164 stool samples of HIV-positive children aged 4 months to 8 years were studied for the excretion of OPV strains. In addition, 23 stool samples from healthy immunocompetent children were analyzed after receiving their OPV immunization. By applying a reverse transcription-polymerase chain reaction in combination with a nested PCR, a total of 54 enteroviruses (EVs) were detected in the stool specimens of the immunodeficient children. Using restriction enzyme analysis, 13 PVs were distinguished from 41 nonpolio EVs (NPEVs). A Sabin-specific RT-triplex PCR confirmed the presence of 7 Sabin PV type 1, 4 Sabin PV type 3, and 2 Sabin PV type 2 isolates. The majority of the NPEV group was made up of 7 coxsackievirus B3 (CBV3), 6 echovirus 11 (ECV11), 5 ECV9, and 3 coxsackievirus A6 (CAV6) isolates. According to the results, two of the immunodeficient patients (P023 and P140) who had received their last OPV immunization more than 15 months before (vaccinated at 14 weeks of age) tested positive for Sabin PVs types 3 and 1, respectively. A 5-year-old immunodeficient patient (P052) who had received her last OPV immunization more than 42 months before (vaccinated at 18 months of age) tested positive for Sabin PV type 1. These results suggested that immunodeficient patients vaccinated with OPV might excrete potentially pathogenic VDPVs for a prolonged period. These VDPVs may circulate in the community, resulting in possible infections in the unvaccinated population. Therefore, the information obtained in this study would be essential for strategies aimed at the protection of both immunodeficient as well as immunocompetent individuals against complications of vaccination with OPV.
Topics: Child; Feces; Humans; Immunocompromised Host; Poliovirus; Poliovirus Vaccine, Oral; Poliovirus Vaccines; South Africa; Vaccination; Virus Shedding
PubMed: 16290028
DOI: 10.1016/j.diagmicrobio.2005.08.011 -
Annual Review of Virology Sep 2018Since the launch of the Global Polio Eradication Initiative (GPEI), paralytic cases associated with wild poliovirus (WPV) have fallen from ∼350,000 in 1988 to 22 in... (Review)
Review
Since the launch of the Global Polio Eradication Initiative (GPEI), paralytic cases associated with wild poliovirus (WPV) have fallen from ∼350,000 in 1988 to 22 in 2017. WPV type 2 (WPV2) was last detected in 1999, WPV3 in 2012, and WPV1 appeared to be localized to Pakistan and Afghanistan in 2017. Through continuous refinement, the GPEI has overcome operational and biological challenges far more complex and daunting than originally envisioned. Operational challenges had led to sustained WPV endemicity in core reservoirs and widespread dissemination to polio-free countries. The biological challenges derive from intrinsic limitations to the oral poliovirus vaccine: ( a) reduced immunogenicity in high-risk settings and ( b) genetic instability, leading to repeated outbreaks of circulating vaccine-derived polioviruses and prolonged infections in individuals with primary immunodeficiencies. As polio eradication enters its multifaceted endgame, the GPEI, with its technical, operational, and social innovations, stands as the preeminent model for control of vaccine-preventable diseases worldwide.
Topics: Communicable Disease Control; Disease Eradication; Disease Transmission, Infectious; Drug Stability; Global Health; Humans; Poliomyelitis; Poliovirus Vaccines
PubMed: 30001183
DOI: 10.1146/annurev-virology-101416-041749 -
The Pan African Medical Journal 2021vaccine utilization monitoring provides valuable information for practical forecasting and formulation of strategies to reduce avoidable wastage. This monitoring is weak...
INTRODUCTION
vaccine utilization monitoring provides valuable information for practical forecasting and formulation of strategies to reduce avoidable wastage. This monitoring is weak at county and health facility levels in South Sudan. Lack of national wastage rates could result in inaccurate forecasting, leading to vaccine shortages or overstocking and expiration of vaccines at the subnational and service delivery points. As the country gears to introduce relatively expensive vaccines such as rotavirus and pneumococcal vaccines, a robust vaccine utilization monitoring system must be rolled out. This study provides the best possible estimates of vaccine wastage rates and the possible causes of the wastage.
METHODS
we conducted the study in 45 conveniently sampled health facilities across 9 of the ten states in South Sudan. Vaccine consumption data was prospectively collected to estimate vaccine wastage and the reason for the wastage of each vaccine type.
RESULTS
wastage of lyophilized vaccines, measles, and Bacillus Calmette-Guérin (BCG) ranged between 39.0-66.7% and 52.1-74.3%, respectively, mainly due to doses that were discarded 6 hours after the opening of the vial or at the end of the immunization session. Wastage of liquid vaccines Oral poliovirus vaccines (OPV), Penta, Inactivated polio vaccine (IPV), and Tetanus- diphtheria (Td) ranged between 24.4-49%, 15.5-43.4%, 25.3-57.9%, and 3.8-57.2%, respectively, mainly due to unusable VVM, expiry, unused doses at the end of outreach sessions, and vials without labels.
CONCLUSION
wasted rates for all vaccines were higher than the indicative WHO wastage rates used in South Sudan to forecast national vaccine needs. Unopened vial wastage was high and needs immediate attention.
Topics: Humans; Immunization; Immunization Programs; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; South Sudan; Vaccination
PubMed: 34887988
DOI: 10.11604/pamj.2021.40.114.28373 -
Journal of Immunological Methods May 2022Next generation poliovirus vaccines are critical to reaching global poliovirus eradication goals. Recent efforts have focused on creating inactivated vaccines using...
Next generation poliovirus vaccines are critical to reaching global poliovirus eradication goals. Recent efforts have focused on creating inactivated vaccines using attenuated Sabin strains that maintain patient safety benefits and immunogenicity of conventional inactivated vaccines while increasing manufacturing safety and lowering production costs, and on developing novel oral vaccines using modified Sabin strains that provide critical mucosal immunity but are further attenuated to minimize risk of reversion to neurovirulence. In addition, there is a push to improve the analytical tools for poliovirus vaccine characterization. Conventional and Sabin inactivated poliovirus vaccines typically rely on standard plate-based ELISA as in vitro D-antigen potency assays in combination with WHO international standards as calibrants. While widely utilized, the current D-antigen ELISA assays have a long time to result (up to 72 h), can suffer from lab-to-lab inconsistency due to non-standardized protocols and reagents, and are inherently singleplex. For D-antigen quantitation, we have developed the VaxArray Polio Assay Kit, a multiplexed, microarray-based immunoassay that uses poliovirus-specific human monoclonal antibodies currently under consideration as standardized reagents for characterizing inactivated Sabin and Salk vaccines. The VaxArray assay can simultaneously quantify all 3 poliovirus serotypes with a time to result of less than 3 h. Here we demonstrate that the assay has limits of quantification suitable for both bioprocess samples and final vaccines, excellent reproducibility and precision, and improved accuracy over an analogous plate-based ELISA. The assay is suitable for adjuvanted combination vaccines, as common vaccine additives and crude matrices do not interfere with quantification, and is intended as a high throughput, standardized quantitation tool to aid inactivated poliovirus vaccine manufacturers in streamlining vaccine development and manufacturing, aiding the global polio eradication effort.
Topics: Antibodies, Viral; Antigens, Viral; Enzyme-Linked Immunosorbent Assay; Humans; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Reproducibility of Results; Vaccines, Inactivated
PubMed: 35314144
DOI: 10.1016/j.jim.2022.113259 -
Vaccine Feb 2018Vaccine-associated paralytic poliomyelitis (VAPP) is one of the most important adverse effects of vaccines that are in current use globally. The Chinese national adverse...
INTRODUCTION
Vaccine-associated paralytic poliomyelitis (VAPP) is one of the most important adverse effects of vaccines that are in current use globally. The Chinese national adverse event following immunization information system (CNAEFIS) is a passive surveillance system which collects data on VAPP.
AIMS
To describe the epidemiological characteristics of VAPP and estimate the risk of recipient VAPP in China.
METHODS
We retrieved information from reported cases of recipient VAPP from CNAEFIS from 2010 to 2015, examined the demographic characteristics of the cases, and used administrative data on vaccination doses and the estimated number of births as denominators to calculate VAPP incidence.
RESULTS
During 2010-2015, 157 cases of recipient VAPP were reported to CNAEFIS (male-to-female ratio, 8.2:1); 151 cases (96.2%) were less than six months old. All cases were associated with trivalent OPV (tOPV), and 89.8% occurred after the receipt of first dose. Of the 157 recipient VAPP cases, type II, type III, and type I poliovirus vaccine strains were isolated from 27 (17.2%) , 25 (15.9%) , and 16 (10.2%) cases, respectively. One case died and one case recovered completely; the other 155 cases had various physical disabilities, such as monolateral or bilateral limping. Using the administered doses of OPV as the denominator, the incidence of recipient VAPP during the study period was estimated at 0.4 per million doses. The estimated recipient VAPP per million births ranged from 1.0 to 2.4 during 2010-2015.
CONCLUSION
The epidemiological characteristics of recipient VAPP cases in China, such as age distribution, were comparable to those in previous studies from other countries. The risk of recipient VAPP, using either estimated births or vaccination doses, was comparable to that in the US and Japan. We recommend using an inactive poliovirus vaccine to decrease the number of recipient VAPP cases in China.
Topics: China; Female; Humans; Immunization Programs; Infant; Infant, Newborn; Male; Poliomyelitis; Poliovirus Vaccine, Oral; Poliovirus Vaccines
PubMed: 29395524
DOI: 10.1016/j.vaccine.2018.01.019 -
Biotechnology (Reading, Mass.) 1992
Review
Topics: Animals; History, 20th Century; Humans; Male; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Vaccines, Inactivated
PubMed: 1318134
DOI: 10.1016/b978-0-7506-9265-6.50015-4 -
Lancet (London, England) Apr 1965
Topics: Bacterial Vaccines; Child; Diphtheria; Diphtheria Toxoid; Humans; Immunization Schedule; Neutralization Tests; Poliomyelitis; Poliovirus Vaccine, Inactivated; Poliovirus Vaccines; Tetanus; Tetanus Toxoid; Vaccination
PubMed: 14272681
DOI: 10.1016/s0140-6736(65)92617-6 -
Vaccine Oct 2011Since the resolution of the World Assembly in 1988 to eradicate polio globally, substantial progress toward this target has been achieved, but the final goal remains... (Review)
Review
Since the resolution of the World Assembly in 1988 to eradicate polio globally, substantial progress toward this target has been achieved, but the final goal remains elusive. India and other tropical developing countries present a unique challenge because of the much lower oral poliovirus vaccine (OPV) immunogenicity compared to industrialized countries, both in terms of humoral and mucosal immunity. To overcome this challenge, further research is needed to elucidate the causes for the suboptimal OPV immunogenicity, better defining the optimal vaccine schedules and delivery strategies, developing and evaluating adjuvants to boost OPV immunogenicity, and improving the methods for directly measuring mucosal immunity.
Topics: Humans; Immunity, Mucosal; India; Poliomyelitis; Poliovirus; Poliovirus Vaccines
PubMed: 21896299
DOI: 10.1016/j.vaccine.2011.08.059 -
Human Vaccines & Immunotherapeutics May 2021This first-in-human study (NCT03032588), conducted in Belgium, evaluated a new inactivated poliovirus vaccines (IPV) candidate based on Sabin poliovirus strains grown on... (Randomized Controlled Trial)
Randomized Controlled Trial
This first-in-human study (NCT03032588), conducted in Belgium, evaluated a new inactivated poliovirus vaccines (IPV) candidate based on Sabin poliovirus strains grown on the high-yield PER.C6® cell line. Healthy adults (N = 32) were randomized (1:1) to receive a single dose of PER.C6-based Sabin-IPV (sIPV, 15:35:112.5 DU/dose) or conventional Salk-IPV (cIPV, 40:8:32 DU/dose). Reactogenicity was assessed up to 7 days after vaccination, immunogenicity 28 days after vaccination, and safety up to 6 months after vaccination.Solicited adverse events (AEs) were mild to moderate, no changes of concern in vital signs or safety laboratory values were observed, and no severe AEs (SAEs) or vaccine-related unsolicited AEs were reported after vaccination. A trend to more frequent solicited AEs after sIPV than after cIPV administration was observed. Most participants had preexisting neutralizing antibodies against poliovirus types (titer ≥8), which were strongly boosted by sIPV. Post-vaccination geometric mean titers were high (≥12,000) and similar across the two vaccination groups. Only participants with very high preexisting antibody levels did not show a vaccine-induced response, defined in seropositive participants as a 4-fold titer increase. The 10 initially seronegative (titer <8) participants (n = 5 in each study group) seroconverted and all participants had seroprotective antibody levels post-vaccination. The antibodies elicited by sIPV neutralized both Sabin and Salk poliovirus strains.In conclusion, the PER.C6®-based sIPV was well tolerated and highly immunogenic in adults with preexisting antibodies to poliovirus.
Topics: Adult; Antibodies, Viral; Belgium; Cell Line; Humans; Immunogenicity, Vaccine; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral
PubMed: 33175637
DOI: 10.1080/21645515.2020.1812315 -
The Journal of Infectious Diseases Nov 2014Polio eradication requires the removal of all polioviruses from human populations, whether wild poliovirus or those emanating from the oral poliovirus vaccine (OPV). The... (Review)
Review
Polio eradication requires the removal of all polioviruses from human populations, whether wild poliovirus or those emanating from the oral poliovirus vaccine (OPV). The Polio Eradication & Endgame Strategic Plan 2013-2018 provides a framework for interruption of wild poliovirus transmission in remaining endemic foci and lays out a plan for the new polio end game, which includes the withdrawal of Sabin strains, starting with type 2, and the introduction of inactivated poliovirus vaccine, for risk mitigation purposes. This report summarizes the rationale and evidence that supports the policy decision to switch from trivalent OPV to bivalent OPV and to introduce 1 dose of inactivated poliovirus vaccine into routine immunization schedules, and it describes the proposed implementation of this policy in countries using trivalent OPV.
Topics: Disease Eradication; Global Health; Humans; Poliomyelitis; Poliovirus Vaccines; Vaccination
PubMed: 25316865
DOI: 10.1093/infdis/jiu222