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Mayo Clinic Proceedings Feb 2020The US Advisory Committee on Immunization Practices recommends that infants beginning at birth receive several vaccines directed against a variety of infectious diseases... (Review)
Review
The US Advisory Committee on Immunization Practices recommends that infants beginning at birth receive several vaccines directed against a variety of infectious diseases that currently pose threats of morbidity and mortality to infants and those around them, including the 3-dose hepatitis B (HepB) series. The first dose is due at birth. This series protects against maternal-infant transmission of the HepB virus and against exposure the rest of the infant's life. At age 2 months infants are to receive not only their second dose of HepB vaccine but also a series of vaccines directed against diphtheria, tetanus, pertussis, pneumococcus, rotavirus, poliovirus, and Haemophilus influenzae type b. At 4 months, infants are to repeat those vaccines except for the HepB vaccine. At age 6 months infants are to finish the HepB series and receive the third doses of the other vaccines received at 2 and 4 months except for the rotavirus vaccine, depending on the brand used. Also, starting at 6 months, depending on the time of year, infants are to begin a 2-dose series against influenza separated by 28 days. Each of these vaccines is due at a time when the vaccine works to protect against an immediate risk and to provide long-term protection. These vaccine-preventable diseases vary in terms of the nature of exposure, the form of the morbidity, the risk of mortality, and the ability of routine vaccination to prevent or ameliorate harm.
Topics: Diphtheria-Tetanus-Pertussis Vaccine; Haemophilus Vaccines; Hepatitis B Vaccines; Humans; Immunization Schedule; Infant; Infant, Newborn; Pneumococcal Vaccines; Poliovirus Vaccines; Rotavirus Vaccines; United States; Vaccination
PubMed: 31879133
DOI: 10.1016/j.mayocp.2019.06.007 -
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 -
Vaccine Jan 2020Several live vaccines may have beneficial non-specific effects (NSEs) reducing mortality more than can be explained by the prevention of the target infection, a... (Review)
Review
Several live vaccines may have beneficial non-specific effects (NSEs) reducing mortality more than can be explained by the prevention of the target infection, a phenomenon which has been linked to innate immune training. Most randomised controlled trials (RCTs) of oral polio vaccine (OPV) and measles vaccine (MV) have shown a large reduction in mortality that must have been at least partly nonspecific because it was much larger than the reduction explained by prevention of the target disease. Hence, stopping a live vaccine after disease-eradication could have negative health effects if the potential beneficial NSEs are not considered. We reviewed one eradicated disease, smallpox, and two infections likely to be eradicated in coming decades, polio and measles. No study was made of unintended effects of stopping smallpox vaccination when it happened in 1980. We have subsequently documented in both Guinea-Bissau and Denmark that smallpox-vaccinated individuals continued to have a survival advantage long after smallpox had been eradicated. The few studies which have examined the effect of OPV on survival all suggest strong beneficial NSEs; in RCTs, OPV compared with inactivated polio vaccine (IPV) has been associated with non-specific reductions in morbidity. RCTs, natural experiments and observational studies have found strong beneficial NSEs for MV. Hence, the imminent eradication of polio and the planned stop of OPV in 2024 and the subsequent eradication of measles infection and the possible stop to live MV could have negative effects for child survival. Before live vaccines are phased out, potential unintended effects of stopping these vaccines should be thoroughly studied.
Topics: BCG Vaccine; Disease Eradication; Guinea-Bissau; Humans; Measles; Measles Vaccine; Mortality; Poliomyelitis; Poliovirus Vaccine, Oral; Randomized Controlled Trials as Topic; Smallpox; Smallpox Vaccine; Tuberculosis
PubMed: 31648913
DOI: 10.1016/j.vaccine.2019.10.034 -
Virus Research Jan 2022An 8-month-old child diagnosed with severe combined immunodeficiency (SCID) was found to be excreting vaccine-derived poliovirus (VDPVs). Five stool samples from the...
An 8-month-old child diagnosed with severe combined immunodeficiency (SCID) was found to be excreting vaccine-derived poliovirus (VDPVs). Five stool samples from the child and stool samples from 24 contacts were collected during the following 7 months. Complete genome sequence by next generation sequencing (NGS) identified 0.7 to 1.4% nucleotide substitutions in the capsid P1 region of the first and the last isolates compared with Sabin 3 strain. Simplot analysis revealed that all isolates were Sabin 3/Sabin 1 recombinants, sharing a single recombination breakpoint in the 2C region. Multiple nucleotide variants were identified in the 5'UTR (T→C and G→A); amino acid mutations were identified in residues at VP1-6 (Thr to Ile), VP1-105 (Met to Thr), VP1-286 (Arg to Lys), VP2-155 (Lys to Glu), VP3-59 (Ser to Asn) and VP3-91 (Phe to Ser). These variants were commonly observed in other PV strains, which may contribute to attenuation and temperature sensitivity. None of the 24 tested contacts of the patient and related transmits was found to be infected with poliovirus. Our study provides a rapid and reliable method for the characterization of VDPV research in Poliovirus infection. In post-OPV era, immunodeficient people with persistent and chronic infection remain a major challenge for polio eradication in China.
Topics: Child; Humans; Infant; Nucleotides; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; Severe Combined Immunodeficiency; Vaccines, Synthetic
PubMed: 34793871
DOI: 10.1016/j.virusres.2021.198633 -
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 -
The Pan African Medical Journal 2023Polio is an infectious and disabling life-threatening disease caused by the poliovirus. This disease is prevented through vaccination. Though this viral infection has...
Polio is an infectious and disabling life-threatening disease caused by the poliovirus. This disease is prevented through vaccination. Though this viral infection has been eliminated in most parts of the world, a few countries are still endemic to wild poliovirus. In 2020, the World Health Organization (WHO) African Region, including Cameroon, was certified free of wild poliovirus. Some countries recurrently report circulating vaccine-derived poliovirus cases (cVDPV) despite recorded achievements. Also, the risk of importing poliovirus from endemic settings remains, particularly in the context of coronavirus disease (COVID-19). This study aimed to assess the state of polio in Cameroon and identify the situation during COVID-19. A data review was conducted from February to March 2023. Data on polio cases and vaccination coverage per region of Cameroon were reviewed from 2014 to 2022. Data were analyzed with Microsoft Excel, and the results were presented as proportions. The last wild poliovirus was reported in Cameroon in 2014, and the country benefitted from a response. No case of poliovirus was detected in the country from 2015 to 2018. After that, an increasing number of type two cVDPV were reported across 50% of the country's regions from 2019 to 2022. The outbreaks benefitted from responses with various oral polio vaccines, including the type two novel oral polio vaccine (nOPV-2). Though wild polioviruses have been eliminated in most countries, including Cameroon, cVDPV remains a significant problem. There is an urgent need to strengthen disease surveillance and vaccination to prevent cVDPV-2 in this country, particularly in the COVID-19 context.
Topics: Humans; Cameroon; Pandemics; COVID-19; Poliomyelitis; Poliovirus; Disease Outbreaks; Poliovirus Vaccine, Oral; Blindness
PubMed: 37663631
DOI: 10.11604/pamj.2023.45.90.35332 -
The American Journal of Tropical... Nov 2023Combining oral (OPV) and inactivated (IPV) poliovirus vaccines prevents importation of poliovirus and emergence of circulating vaccine-derived poliovirus. We measured...
Combining oral (OPV) and inactivated (IPV) poliovirus vaccines prevents importation of poliovirus and emergence of circulating vaccine-derived poliovirus. We measured the coverage with IPV and third dose of OPV (OPV-3) and identified determinants of coverage inequality in the most at-risk populations in Ethiopia. A national survey representing 10 partly overlapping underserved populations-pastoralists, conflict-affected areas, urban slums, hard-to-reach settings, developing regions, newly formed regions, internally displaced people (IDPs), refugees, and districts neighboring international and interregional boundaries-was conducted among children 12 to 35 months old (N = 3,646). Socioeconomic inequality was measured using the concentration index (CIX) and decomposed using a regression-based approach. One-third (95% CI: 31.5-34.0%) of the children received OPV-3 and IPV. The dual coverage was below 50% in developing regions (19.2%), pastoralists (22.0%), IDPs (22.3%), districts neighboring international (24.1%) and interregional (33.3%) boundaries, refugees (27.0%), conflict-affected areas (29.3%), newly formed regions (33.5%), and hard-to-reach areas (38.9%). Conversely, coverage was better in urban slums (78%). Children from poorest households, living in villages that do not have health posts, and having limited health facility access had increased odds of not receiving the vaccines. Low paternal education, dissatisfaction with vaccination service, fear of vaccine side effects, living in female-headed households, having employed and less empowered mothers were also risk factors. IPV-OPV3 coverage favored the rich (CIX = -0.161, P < 0.001), and causes of inequality were: inaccessibility of health facilities (13.3%), dissatisfaction with vaccination service (12.8%), and maternal (4.9%) and paternal (4.9%) illiteracy. Polio vaccination coverage in the most at-risk populations in Ethiopia is suboptimal, threatening the polio eradication initiative.
Topics: Child, Preschool; Humans; Infant; Ethiopia; Poliomyelitis; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Risk Factors; Vaccination
PubMed: 37748762
DOI: 10.4269/ajtmh.23-0319 -
The Lancet. Infectious Diseases Apr 2021Following the global eradication of wild poliovirus, countries using live attenuated oral poliovirus vaccines will transition to exclusive use of inactivated poliovirus...
BACKGROUND
Following the global eradication of wild poliovirus, countries using live attenuated oral poliovirus vaccines will transition to exclusive use of inactivated poliovirus vaccine (IPV) or fractional doses of IPV (f-IPV; a f-IPV dose is one-fifth of a normal IPV dose), but IPV supply and cost constraints will necessitate dose-sparing strategies. We compared immunisation schedules of f-IPV and IPV to inform the choice of optimal post-eradication schedule.
METHODS
This randomised open-label, multicentre, phase 3, non-inferiority trial was done at two centres in Panama and one in the Dominican Republic. Eligible participants were healthy 6-week-old infants with no signs of febrile illness or known allergy to vaccine components. Infants were randomly assigned (1:1:1:1, 1:1:1:2, 2:1:1:1), using computer-generated blocks of four or five until the groups were full, to one of four groups and received: two doses of intradermal f-IPV (administered at 14 and 36 weeks; two f-IPV group); or three doses of intradermal f-IPV (administered at 10, 14, and 36 weeks; three f-IPV group); or two doses of intramuscular IPV (administered at 14 and 36 weeks; two IPV group); or three doses of intramuscular IPV (administered at 10, 14, and 36 weeks; three IPV group). The primary outcome was seroconversion rates based on neutralising antibodies for poliovirus type 1 and type 2 at baseline and at 40 weeks (4 weeks after the second or third vaccinations) in the per-protocol population to allow non-inferiority and eventually superiority comparisons between vaccines and regimens. Three co-primary outcomes concerning poliovirus types 1 and 2 were to determine if seroconversion rates at 40 weeks of age after a two-dose regimen (administered at weeks 14 and 36) of intradermally administered f-IPV were non-inferior to a corresponding two-dose regimen of intramuscular IPV; if seroconversion rates at 40 weeks of age after a two-dose IPV regimen (weeks 14 and 36) were non-inferior to those after a three-dose IPV regimen (weeks 10, 14, and 36); and if seroconversion rates after a two-dose f-IPV regimen (weeks 14 and 36) were non-inferior to those after a three-dose f-IPV regimen (weeks 10, 14, and 36). The non-inferiority boundary was set at -10% for the lower bound of the two-sided 95% CI for the seroconversion rate difference.. Safety was assessed as serious adverse events and important medical events. This study is registered on ClinicalTrials.gov, NCT03239496.
FINDINGS
From Oct 23, 2017, to Nov 13, 2018, we enrolled 773 infants (372 [48%] girls) in Panama and the Dominican Republic (two f-IPV group n=217, three f-IPV group n=178, two IPV group n=178, and three IPV group n=200). 686 infants received all scheduled vaccine doses and were included in the per-protocol analysis. We observed non-inferiority for poliovirus type 1 seroconversion rate at 40 weeks for the two f-IPV dose schedule (95·9% [95% CI 92·0-98·2]) versus the two IPV dose schedule (98·7% [95·4-99·8]), and for the three f-IPV dose schedule (98·8% [95·6-99·8]) versus the three IPV dose schedule (100% [97·9-100]). Similarly, poliovirus type 2 seroconversion rate at 40 weeks for the two f-IPV dose schedule (97·9% [94·8-99·4]) versus the two IPV dose schedule (99·4% [96·4-100]), and for the three f-IPV dose schedule (100% [97·7-100]) versus the three IPV dose schedule (100% [97·9-100]) were non-inferior. Seroconversion rate for the two f-IPV regimen was statistically superior 4 weeks after the last vaccine dose in the 14 and 36 week schedule (95·9% [92·0-98·2]) compared with the 10 and 14 week schedule (83·2% [76·5-88·6]; p=0·0062) for poliovirus type 1. Statistical superiority of the 14 and 36 week schedule was also found for poliovirus type 2 (14 and 36 week schedule 97·9% [94·8-99·4] vs 10 and 14 week schedule 83·9% [77·2-89·2]; p=0·0062), and poliovirus type 3 (14 and 36 week schedule 84·5% [78·7-89·3] vs 10 and 14 week schedule 73·3% [65·8-79·9]; p=0·0062). For IPV, a two dose regimen administered at 14 and 36 weeks (99·4% [96·4-100]) was superior a 10 and 14 week schedule (88·9% [83·4-93·1]; p<0·0001) for poliovirus type 2, but not for type 1 (14 and 36 week schedule 98·7% [95·4-99·8] vs 10 and 14 week schedule 95·6% [91·4-98·1]), or type 3 (14 and 36 week schedule 97·4% [93·5-99·3] vs 10 and 14 week schedule 93·9% [89·3-96·9]). There were no related serious adverse events or important medical events reported in any group showing safety was unaffected by administration route or schedule.
INTERPRETATION
Our observations suggest that adequate immunity against poliovirus type 1 and type 2 is provided by two doses of either IPV or f-IPV at 14 and 36 weeks of age, and broad immunity is provided with three doses of f-IPV, enabling substantial savings in cost and supply. These novel clinical data will inform global polio immunisation policy for the post-eradication era.
FUNDING
Bill & Melinda Gates Foundation.
Topics: Antibodies, Viral; Dominican Republic; Female; Humans; Immunization Schedule; Immunogenicity, Vaccine; Infant; Infant, Newborn; Male; Panama; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Seroconversion
PubMed: 33284114
DOI: 10.1016/S1473-3099(20)30555-7 -
The Journal of Infectious Diseases Nov 2021Pakistan and Afghanistan remain the only reservoirs of wild poliovirus transmission. Prior modeling suggested that before the coronavirus disease 2019 (COVID-19)...
BACKGROUND
Pakistan and Afghanistan remain the only reservoirs of wild poliovirus transmission. Prior modeling suggested that before the coronavirus disease 2019 (COVID-19) pandemic, plans to stop the transmission of serotype 1 wild poliovirus (WPV1) and persistent serotype 2 circulating vaccine-derived poliovirus (cVDPV2) did not appear on track to succeed.
METHODS
We updated an existing poliovirus transmission and Sabin-strain oral poliovirus vaccine (OPV) evolution model for Pakistan and Afghanistan to characterize the impacts of immunization disruptions and restrictions on human interactions (ie, population mixing) due to the COVID-19 pandemic. We also consider different options for responding to outbreaks and for preventive supplementary immunization activities (SIAs).
RESULTS
The modeling suggests that with some resumption of activities in the fall of 2020 to respond to cVDPV2 outbreaks and full resumption on 1 January 2021 of all polio immunization activities to pre-COVID-19 levels, Pakistan and Afghanistan would remain off-track for stopping all transmission through 2023 without improvements in quality.
CONCLUSIONS
Using trivalent OPV (tOPV) for SIAs instead of serotype 2 monovalent OPV offers substantial benefits for ending the transmission of both WPV1 and cVDPV2, because tOPV increases population immunity for both serotypes 1 and 2 while requiring fewer SIA rounds, when effectively delivered in transmission areas.
Topics: Afghanistan; COVID-19; Disease Eradication; Disease Outbreaks; Humans; Pakistan; Pandemics; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Oral; SARS-CoV-2
PubMed: 33885734
DOI: 10.1093/infdis/jiab160