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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 -
International Health Mar 2023
Topics: Humans; Poliovirus; Poliomyelitis; Poliovirus Vaccine, Oral; Global Health; Disease Eradication
PubMed: 36271900
DOI: 10.1093/inthealth/ihac068 -
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 -
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 -
Risk Analysis : An Official Publication... Feb 2021Beginning in 2013, multiple local government areas (LGAs) in Borno and Yobe in northeast Nigeria and other parts of the Lake Chad basin experienced a violent insurgency...
Beginning in 2013, multiple local government areas (LGAs) in Borno and Yobe in northeast Nigeria and other parts of the Lake Chad basin experienced a violent insurgency that resulted in substantial numbers of isolated and displaced people. Northeast Nigeria represents the last known reservoir country of wild poliovirus (WPV) transmission in Africa, with detection of paralytic cases caused by serotype 1 WPV in 2016 in Borno and serotype 3 WPV in late 2012. Parts of Borno and Yobe are also problematic areas for transmission of serotype 2 circulating vaccine-derived polioviruses, and they continue to face challenges associated with conflict and inadequate health services in security-compromised areas that limit both immunization and surveillance activities. We model poliovirus transmission of all three serotypes for Borno and Yobe using a deterministic differential equation-based model that includes four subpopulations to account for limitations in access to immunization services and dynamic restrictions in population mixing. We find that accessibility issues and insufficient immunization allow for prolonged poliovirus transmission and potential undetected paralytic cases, although as of the end of 2019, including responsive program activities in the modeling suggest die out of indigenous serotypes 1 and 3 WPVs prior to 2020. Specifically, recent and current efforts to access isolated populations and provide oral poliovirus vaccine continue to reduce the risks of sustained and undetected transmission, although some uncertainty remains. Continued improvement in immunization and surveillance in the isolated subpopulations should minimize these risks. Stochastic modeling can build on this analysis to characterize the implications for undetected transmission and confidence about no circulation.
Topics: Child; Child, Preschool; Disease Outbreaks; Humans; Immunization Programs; Infant; Nigeria; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Poliovirus Vaccines; Risk Assessment; Vaccination
PubMed: 32348621
DOI: 10.1111/risa.13485 -
Human Vaccines & Immunotherapeutics Dec 2022The DTacP-sIPV-Hib combination vaccine can replace the single-component acellular pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type B vaccines. In...
The DTacP-sIPV-Hib combination vaccine can replace the single-component acellular pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type B vaccines. In this study, we evaluated the safety and immunogenicity of a newly developed DTacP-sIPV-Hib combination vaccine in animal models. We used 40 mice and 46 cynomolgus monkeys to evaluate acute and long-term toxicity. Thirty-six guinea pigs were used for sensitization assessment. For immunogenicity assessment, 50 NIH mice and 50 rats were equally randomized to receive 3 doses of 3 different batches of the tested vaccine at an interval of 21 d, or physiological saline solution (0.5 mL). Orbital blood was collected at an interval of 21 d post inoculation to detect related antibody titers or neutralizing antibody titers against poliovirus. Gross autopsy and histopathological examination revealed no abnormal toxicity or irritation in mice and cynomolgus monkeys. Sensitization assessment in guinea pigs indicated the lack of evident allergic symptoms in the high- and low-dose vaccine groups within 30 min after repeated stimulation. The DTacP-sIPV-Hib combination vaccine induced significant immune responses in mice, rats, and cynomolgus monkeys, with 100% seroconversion rates after 3 doses. The DTacP-sIPV-Hib combination vaccine is safe and immunogenic in animal models. Three doses of the vaccine elicited satisfactory antibody responses in mice, rats, and cynomolgus monkeys.
Topics: Animals; Guinea Pigs; Mice; Rats; Antibodies, Bacterial; Haemophilus influenzae type b; Haemophilus Vaccines; Hepatitis B Vaccines; Macaca fascicularis; Models, Animal; Poliovirus Vaccine, Inactivated; Vaccines, Combined; Diphtheria-Tetanus-acellular Pertussis Vaccines
PubMed: 36576263
DOI: 10.1080/21645515.2022.2160158 -
International Journal of Infectious... Dec 2023During the COVID-19 pandemic, there was a decline in vaccine coverage, and the implementation of combined vaccines and co-administration strategies emerged as potential... (Randomized Controlled Trial)
Randomized Controlled Trial
Immunogenicity and safety of concomitant administration of the sabin-strain-based inactivated poliovirus vaccine, the diphtheria-tetanus-acellular pertussis vaccine, and measles-mumps-rubella vaccine to healthy infants aged 18 months in China.
OBJECTIVES
During the COVID-19 pandemic, there was a decline in vaccine coverage, and the implementation of combined vaccines and co-administration strategies emerged as potential solutions to alleviate this predicament. Our objective is to delve into the concurrent administration of the sabin-strain-based inactivated poliovirus vaccine (sIPV), the diphtheria-tetanus-acellular pertussis vaccine (DTaP), and measles-mumps-rubella vaccine (MMR), with the intention of bridging the evidentiary gap pertaining to vaccine co-administration in Chinese infants, and to ensure a safe and effective vaccination strategy, ultimately leading to an augmentation in immunization coverage.
METHODS
This study was a follow-up trial of the "Immunogenicity and safety of concomitant administration of the sIPV with the DTaP vaccine in children: a multicenter, randomized, non-inferiority, controlled trial." Blood samples were collected on day 0 and day 30, and serum antibody levels were detected to measure antibody responses to each of the antigens. Local and systemic adverse events were monitored and compared among groups. This study is the first to fill the knowledge gap in China regarding the safe and effective combined vaccination of sIPV, DTaP, and MMR vaccines.
RESULTS
The geometric mean titer of the poliovirus types I, II, and III neutralizing antibodies were 1060.22 (95% CI: 865.73-1298.39), 1537.06 (95% CI: 1324.27-1784.05), and 1539.10 (95% CI: 1296.37-1827.29) in group I on day 30; geometric mean titer of antibodies against DTaP and MMR in the simultaneous vaccination group was non-inferior to those in the DTaP alone and MMR alone group. Reporting rates of local and systemic adverse reactions were similar between groups and no serious adverse events were reported throughout the clinical study period.
CONCLUSION
Co-administration of the sIPV, DTaP, and MMR was safe and did not impact immunogenicity, which would help to mitigate administrative costs and enhance vaccine coverage rates.
Topics: Child; Humans; Infant; Diphtheria-Tetanus-acellular Pertussis Vaccines; Measles-Mumps-Rubella Vaccine; Poliovirus Vaccine, Inactivated; Pandemics; Vaccines, Combined; Poliovirus; Diphtheria-Tetanus-Pertussis Vaccine; Haemophilus Vaccines; Antibodies, Bacterial; Immunization Schedule
PubMed: 37832931
DOI: 10.1016/j.ijid.2023.10.006 -
Expert Review of Vaccines Nov 2022Multiple vaccine options are available for polio prevention and risk management. Integrated global risk, economic, and poliovirus transmission modeling provides a tool...
BACKGROUND
Multiple vaccine options are available for polio prevention and risk management. Integrated global risk, economic, and poliovirus transmission modeling provides a tool to explore the dynamics of ending all use of one or more poliovirus vaccines to simplify the polio eradication endgame.
RESEARCH DESIGN AND METHODS
With global reported cases of poliomyelitis trending higher since 2016, we apply an integrated global model to simulate prospective vaccine policies and strategies for OPV-using countries starting with initial conditions that correspond to the epidemiological poliovirus transmission situation at the beginning of 2022.
RESULTS
Abruptly ending all OPV use in 2023 and relying only on IPV to prevent paralysis with current routine immunization coverage would lead to expected reestablished endemic transmission of poliovirus types 1 and 2, and approximately 150,000 expected cases of poliomyelitis per year. Alternatively, if OPV-using countries restart trivalent OPV (tOPV) use for all immunization activities and end IPV use, the model shows the lowest anticipated annual polio cases and lowest costs.
CONCLUSIONS
Poor global risk management and coordination of OPV cessation remain a critical failure mode for the polio endgame, and national and global decision makers face difficult choices due to multiple available polio vaccine options and immunization strategies.
Topics: Humans; Poliovirus Vaccine, Oral; Poliovirus Vaccine, Inactivated; Disease Eradication; Global Health; Poliomyelitis; Poliovirus
PubMed: 36154436
DOI: 10.1080/14760584.2022.2128108 -
The Pediatric Infectious Disease Journal Aug 2023This study investigated the immunogenicity and safety of a fully liquid, hexavalent, diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus... (Randomized Controlled Trial)
Randomized Controlled Trial
Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand.
BACKGROUND
This study investigated the immunogenicity and safety of a fully liquid, hexavalent, diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)- Haemophilus influenzae b (PRP-T) vaccine compared to licensed DTwP-HB-PRP~T, IPV, and bivalent oral poliovirus (bOPV) vaccines following co-administration with other pediatric vaccines [pneumococcal conjugate vaccine (PCV13) and rotavirus vaccine].
METHODS
Phase III, randomized, open-label study in Thailand. Healthy infants received DTwP-IPV-HB-PRP~T at 2, 4 and 6 months of age (N = 228), or DTwP-HB-PRP~T and bOPV (2, 4 and 6 months of age) and IPV (4 months of age) (N = 231). All participants received PCV13 (2, 4 and 6 months of age) and rotavirus vaccine (2 and 4 months of age). Immunogenicity for all antigens was assessed using validated assays, and noninferiority post-third dose was evaluated for anti-D, anti-T, anti-pertussis [anti-pertussis toxin (anti-PT) and anti-fimbriae 2/3 (anti-FIM)], anti-polio 1, 2, 3, anti-HB, and anti-PRP~T. Safety was assessed using parental reports.
RESULTS
Noninferiority was demonstrated for each antigen, and overall noninferiority of DTwP-IPV-HB-PRP~T versus DTwP-HB-PRP~T+bOPV+IPV was concluded. Similarity in each group was observed for the GMC ratio for antirotavirus antibodies (20.9 and 17.3, respectively) and anti-PCV13 antibodies (range: 8.46-32.6 and 7.53-33.1, respectively). Two serious adverse events were related to DTwP-IPV-HB-PRP~T (febrile convulsion and acute febrile illness) and 1 was related to DTwP-HB-PRP~T+bOPV+IPV (febrile seizure), but overall there were no safety concerns with similar rates of participants experiencing solicited (99.1% and 98.3%) and unsolicited (19.3% and 19.5%) adverse events in each group.
CONCLUSIONS
This study confirmed the suitability of DTwP-IPV-HB-PRP~T primary series vaccination in combination with rotavirus and PCV13 vaccines.
Topics: Humans; Infant; Antibodies, Bacterial; Antibodies, Viral; Diphtheria-Tetanus-Pertussis Vaccine; Haemophilus Vaccines; Hepatitis B; Hepatitis B Vaccines; Immunization Schedule; Poliovirus Vaccine, Inactivated; Rotavirus Vaccines; Thailand; Vaccines, Combined; Vaccines, Conjugate; Pneumococcal Vaccines; Immunogenicity, Vaccine
PubMed: 37257121
DOI: 10.1097/INF.0000000000003975