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The Journal of Infectious Diseases Aug 2022We conducted a trial in Nigeria to assess the immunogenicity of the new bivalent oral poliovirus vaccine + inactivated poliovirus vaccine (bOPV+IPV) immunization... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
We conducted a trial in Nigeria to assess the immunogenicity of the new bivalent oral poliovirus vaccine + inactivated poliovirus vaccine (bOPV+IPV) immunization schedule and gains in type 2 immunity with addition of second dose of IPV. The trial was conducted in August 2016-March 2017, well past the trivalent OPV-bOPV switch in April 2016.
METHODS
This was an open-label, 2-arm, noninferiority, multicenter, randomized, controlled trial. We enrolled 572 infants aged ≤14 days and randomized them into 2 arms. Arm A received bOPV at birth, 6, and 10 weeks, bOPV+IPV at week 14, and IPV at week 18. Arm B received IPV each at 6, 10, and 14 weeks and bOPV at 18 weeks of age.
RESULTS
Seroconversion rates for poliovirus types 1 and 3, respectively, were 98.9% (95% confidence interval [CI], 96.7-99.8) and 98.1% (95% CI, 88.2-94.8) in Arm A and 89.6% (95% CI, 85.4-93.0) and 98.5% (95% CI, 96.3-99.6) in Arm B. Type 2 seroconversion with 1 dose IPV in Arm A was 72.0% (95% CI, 66.2-77.3), which increased significantly with addition of second dose to 95.9% (95% CI, 92.8-97.9).
CONCLUSIONS
This first trial on the new Expanded Program on Immunization (EPI) schedule in a sub-Saharan African country demonstrated excellent immunogenicity against poliovirus types 1 and 3 and substantial/enhanced immunogenicity against poliovirus type 2 after 1 to 2 doses of IPV, respectively.
Topics: Antibodies, Viral; Child; Humans; Immunization Schedule; Infant; Infant, Newborn; Nigeria; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Vaccines, Combined
PubMed: 33230550
DOI: 10.1093/infdis/jiaa726 -
Risk Analysis : An Official Publication... Feb 2021Countries face different poliovirus risks, which imply different benefits associated with continued and future use of oral poliovirus vaccine (OPV) and/or inactivated...
Countries face different poliovirus risks, which imply different benefits associated with continued and future use of oral poliovirus vaccine (OPV) and/or inactivated poliovirus vaccine (IPV). With the Global Polio Eradication Initiative (GPEI) continuing to extend its timeline for ending the transmission of all wild polioviruses and to introduce new poliovirus vaccines, the polio vaccine supply chain continues to expand in complexity. The increased complexity leads to significant uncertainty about supply and costs. Notably, the strategy of phased OPV cessation of all three serotypes to stop all future incidence of poliomyelitis depends on successfully stopping the transmission of all wild polioviruses. Countries also face challenges associated with responding to any outbreaks that occur after OPV cessation, because stopping transmission of such outbreaks requires reintroducing the use of the stopped OPV in most countries. National immunization program leaders will likely consider differences in their risks and willingness-to-pay for risk reduction as they evaluate their investments in current and future polio vaccination. Information about the costs and benefits of future poliovirus vaccines, and discussion of the complex situation that currently exists, should prove useful to national, regional, and global decisionmakers and support health economic modeling. Delays in achieving polio eradication combined with increasing costs of poliovirus vaccines continue to increase financial risks for the GPEI.
Topics: Costs and Cost Analysis; Disease Eradication; Disease Outbreaks; Global Health; Health Care Costs; Humans; Immunization Programs; Models, Economic; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Risk; Risk Management; Serogroup; Vaccination
PubMed: 32645244
DOI: 10.1111/risa.13557 -
International Health Mar 2023
Topics: Humans; Poliovirus; Poliomyelitis; Poliovirus Vaccine, Oral; Global Health; Disease Eradication
PubMed: 36271900
DOI: 10.1093/inthealth/ihac068 -
Emerging Infectious Diseases May 2021In 2019, the Public Health Agency of Barcelona, Spain, was notified of a vaccine-derived poliovirus infection. The patient had an underlying common variable...
In 2019, the Public Health Agency of Barcelona, Spain, was notified of a vaccine-derived poliovirus infection. The patient had an underlying common variable immunodeficiency and no signs of acute flaccid paralysis. We describe the ongoing coordinated response to contain the infection, which included compassionate-use treatment with pocapavir.
Topics: Disease Eradication; Humans; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Spain
PubMed: 33900188
DOI: 10.3201/eid2705.204675 -
Current Opinion in Neurology Jun 2023Recent outbreaks of poliomyelitis in countries that have been free of cases for decades highlight the challenges of eradicating polio in a globalized interconnected... (Review)
Review
PURPOSE OF REVIEW
Recent outbreaks of poliomyelitis in countries that have been free of cases for decades highlight the challenges of eradicating polio in a globalized interconnected world beset with a novel viral pandemic. We provide an epidemiological update, advancements in vaccines, and amendments in public health strategy of poliomyelitis in this review.
RECENT FINDINGS
Last year, new cases of wild poliovirus type 1 (WPV1) were documented in regions previously documented to have eradicated WPV1 and reports of circulating vaccine-derived poliovirus type 2 (cVDPV2) and 3 (cVDPV3) in New York and Jerusalem made international headlines. Sequencing of wastewater samples from environmental surveillance revealed that the WPV1 strains were related to WPV1 lineages from endemic countries and the cVDPV2 strains from New York and Jerusalem were not only related to each other but also to environmental isolates found in London. The evidence of importation of WPV1 cases from endemic countries, and global transmission of cVDPVs justifies renewed efforts in routine vaccination programs and outbreak control measures that were interrupted by the COVID-19 pandemic. After the novel oral poliovirus vaccine type 2 (nOPV2) received emergency authorization for containment of cVDPV2 outbreaks in 2021, subsequent reduced incidence, transmission rates, and vaccine adverse events, alongside increased genetic stability of viral isolates substantiates the safety and efficacy of nOPV2. The nOPV1 and nOPV3 vaccines, against type 1 and 3 cVDPVs, and measures to increase accessibility and efficacy of inactivated poliovirus vaccine (IPV) are in development.
SUMMARY
A revised strategy utilizing more genetically stable vaccine formulations, with uninterrupted vaccination programs and continued active surveillance optimizes the prospect of global poliomyelitis eradication.
Topics: Humans; Poliovirus; Pandemics; COVID-19; Poliovirus Vaccine, Oral; Poliomyelitis; Disease Outbreaks
PubMed: 37078665
DOI: 10.1097/WCO.0000000000001156 -
Expert Review of Vaccines Jul 2020Over the last 20 years (2000-2019) the partners of the Global Polio Eradication Initiative (GPEI) invested in the development and application of mathematical models of... (Review)
Review
INTRODUCTION
Over the last 20 years (2000-2019) the partners of the Global Polio Eradication Initiative (GPEI) invested in the development and application of mathematical models of poliovirus transmission as well as economics, policy, and risk analyses of polio endgame risk management options, including policies related to poliovirus vaccine use during the polio endgame.
AREAS COVERED
This review provides a historical record of the polio studies published by the three modeling groups that primarily performed the bulk of this work. This review also systematically evaluates the polio transmission and health economic modeling papers published in English in peer-reviewed journals from 2000 to 2019, highlights differences in approaches and methods, shows the geographic coverage of the transmission modeling performed, identified common themes, and discusses instances of similar or conflicting insights or recommendations.
EXPERT OPINION
Polio modeling performed during the last 20 years substantially impacted polio vaccine choices, immunization policies, and the polio eradication pathway. As the polio endgame continues, national preferences for polio vaccine formulations and immunization strategies will likely continue to change. Future modeling will likely provide important insights about their cost-effectiveness and their relative benefits with respect to controlling polio and potentially achieving and maintaining eradication.
Topics: Disease Eradication; Global Health; Humans; Immunization Programs; Models, Economic; Models, Theoretical; Poliomyelitis; Poliovirus Vaccines; Risk Management; Vaccination
PubMed: 32741232
DOI: 10.1080/14760584.2020.1791093 -
The Journal of Infectious Diseases Apr 2021Fractional dose (one-fifth of full intramuscular dose) of inactivated poliovirus vaccine (fIPV) administered intradermally is used as IPV dose-sparing strategy. We... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Fractional dose (one-fifth of full intramuscular dose) of inactivated poliovirus vaccine (fIPV) administered intradermally is used as IPV dose-sparing strategy. We compared the rate of decline of poliovirus antibodies (PVA) in recipients of 2 doses of fIPV or IPV.
METHODS
A community-based randomized controlled trial was conducted in Karachi, Pakistan. Children aged 14 weeks were randomized into fIPV or full IPV (study arms A, B) and received 1 vaccine dose at age 14 weeks and 1 at age 9 months. PVAs were measured at age 14, 18 weeks and 10, 21 months.
RESULTS
Seroprevalence of poliovirus type 2 antibodies in 170/250 (68%) children after 2 IPV or fIPV doses at age 10 months in A and B reached 100% vs 99% (P = .339), and at 21 months, 86% vs 67% (P = .004). Between age 10 and 21 months antibody log2 titers dropped from ≥ 10.5 to 6.8 in A and from 9.2 to 3.7 in B.
CONCLUSIONS
There was a significant decline in antibody titers 12 months following the second IPV dose. The slope of decline was similar for full IPV and fIPV recipients. The results provide further evidence that fIPV is a viable option for IPV dose-sparing.
CLINICAL TRIALS REGISTRATION
NCT03286803.
Topics: Antibodies, Viral; Dose-Response Relationship, Immunologic; Humans; Immunization Schedule; Infant; Injections, Intradermal; Pakistan; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Seroepidemiologic Studies
PubMed: 32798224
DOI: 10.1093/infdis/jiaa504 -
Risk Analysis : An Official Publication... Apr 2023Pakistan and Afghanistan pose risks for international transmission of polioviruses as the last global reservoir for wild poliovirus type 1 (WPV1) and a reservoir for...
Pakistan and Afghanistan pose risks for international transmission of polioviruses as the last global reservoir for wild poliovirus type 1 (WPV1) and a reservoir for type 2 circulating vaccine-derived polioviruses (cVDPV2s). Widespread transmission of WPV1 and cVDPV2 in 2019-2020 and resumption of intensive supplemental immunization activities (SIAs) in 2020-2021 using oral poliovirus vaccine (OPV) led to decreased transmission of WPV1 and cVDPV2 as of the end of 2021. Using an established dynamic disease transmission model, we explore multiple bounding scenarios with varying intensities of SIAs using bivalent OPV (bOPV) and/or trivalent tOPV (tOPV) to characterize potential die out of transmission. This analysis demonstrates potential sets of actions that may lead to elimination of poliovirus transmission in Pakistan and/or Afghanistan. Some modeled scenarios suggest that Pakistan and Afghanistan could increase population immunity to levels high enough to eliminate transmission, and if maintained, achieve WPV1 and cVDPV2 elimination as early as 2022. This requires intensive and proactive OPV SIAs to prevent transmission, instead of surveillance followed by reactive outbreak response. The reduction of cases observed in 2021 may lead to a false sense of security that polio has already or soon will die out on its own, but relaxation of immunization activities runs the risk of lowering population immunity to, or below, the minimum die-out threshold such that transmission continues. Transmission modeling may play a key role in managing expectations and supporting future modeling about the confidence of no virus circulation in anticipation of global certification decisions.
Topics: Humans; Poliovirus; Afghanistan; Pakistan; Poliovirus Vaccine, Oral; Poliomyelitis
PubMed: 35739080
DOI: 10.1111/risa.13983 -
Human Vaccines & Immunotherapeutics Dec 2023This Phase I study evaluated the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), via subcutaneous (SC) or... (Randomized Controlled Trial)
Randomized Controlled Trial
This Phase I study evaluated the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), via subcutaneous (SC) or intramuscular (IM) administration, in healthy Japanese infants 3 months of age. A total of 133 participants were randomized to receive four doses (3 + 1 regimen) of V114-SC ( = 44), V114-IM ( = 45), or 13-valent PCV (PCV13)-SC ( = 44) at 3, 4, 5, and 12-15 months of age. Diphtheria, tetanus, and pertussis-inactivated poliovirus (DTaP-IPV) vaccine was administered concomitantly at all vaccination visits. The primary objective was to assess the safety and tolerability of V114-SC and V114-IM. Secondary objectives were to assess the immunogenicity of PCV and DTaP-IPV at 1-month post-dose 3 (PD3). On days 1-14 following each vaccination, the proportions of participants with systemic adverse events (AEs) were comparable across interventions, whereas injection-site AEs were higher with V114-SC (100.0%) and PCV13-SC (100.0%) than with V114-IM (88.9%). Most AEs were mild or moderate in severity and no vaccine-related serious AEs or deaths were reported. Serotype-specific immunoglobulin G (IgG) response rates at 1-month PD3 were comparable across groups for most shared serotypes between V114 and PCV13. For additional V114 serotypes 22F and 33F, IgG response rates were higher with V114-SC and V114-IM than with PCV13-SC. DTaP-IPV antibody response rates at 1-month PD3 for V114-SC and V114-IM were comparable with PCV13-SC. Findings suggest that vaccination with V114-SC or V114-IM in healthy Japanese infants is generally well tolerated and immunogenic.
Topics: Humans; Infant; Antibodies, Bacterial; East Asian People; Immunogenicity, Vaccine; Immunoglobulin G; Pneumococcal Infections; Pneumococcal Vaccines; Poliovirus Vaccine, Inactivated; Tetanus Toxoid; Vaccines, Conjugate; Vaccines, Combined
PubMed: 36882898
DOI: 10.1080/21645515.2023.2180973 -
BMJ Open Sep 2022To assess the contribution of partners in the introduction of two new vaccines concurrently: pneumococcal 10-valent conjugate vaccine (PCV-10) and inactivated polio... (Review)
Review
OBJECTIVE
To assess the contribution of partners in the introduction of two new vaccines concurrently: pneumococcal 10-valent conjugate vaccine (PCV-10) and inactivated polio vaccine (IPV) into the routine Expanded Programme on Immunization (EPI) in Bangladesh.
DESIGN
We conducted a prospective process evaluation that included the theory of change development, root cause analysis and in-depth investigation. As part of process tracking, we reviewed relevant documents, observed trainers' and vaccinators' training and key stakeholder meetings. We analysed the data thematically.
SETTING
We purposively selected eight (subdistrict) and one city corporation covering nine districts and seven administrative divisions of Bangladesh.
PARTICIPANTS
Nineteen national key informants were interviewed and 16 frontline health workers were invited to the group discussions considering their involvement in the vaccine introduction process.
RESULTS
The EPI experienced several challenges during the joint introduction of PCV-10 and IPV, such as frequent changes in the vaccine introduction schedule, delays in budget allocation, vaccine supply shortage and higher wastage rates of IPV. EPI addressed these challenges in collaboration with its partners, that is, the World Health Organization (WHO) and United Nations Children's Fund (UNICEF), who provided technical assistance to develop a training curriculum and communication materials and enhanced demand generation at the community level. In addition, the WHO conducted a country readiness assessment for PCV-10, and UNICEF supported vaccine shipment. Other government ministries, City Corporations and municipalities also supported the EPI.
CONCLUSIONS
The partnership among the EPI stakeholders effectively addressed various operational challenges during the joint introduction of PCV-10 and IPV helped strengthen Bangladesh's immunisation systems. These accomplishments are attributed to several factors that should be supported and strengthened for future vaccine introductions in Bangladesh and other low and-middle countries.
Topics: Bangladesh; Child; Humans; Immunization Programs; Pneumococcal Vaccines; Poliovirus Vaccine, Inactivated; Program Evaluation; Prospective Studies; Vaccines, Conjugate
PubMed: 36167397
DOI: 10.1136/bmjopen-2022-061742