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Human Vaccines & Immunotherapeutics Aug 2021The switch from using only trivalent oral polio vaccine (tOPV) to sequential schedules combining inactivated poliovirus vaccine (IPV) and bivalent oral polio vaccine...
The switch from using only trivalent oral polio vaccine (tOPV) to sequential schedules combining inactivated poliovirus vaccine (IPV) and bivalent oral polio vaccine (bOPV) for polio vaccination will cause changes to mucosal immunity against polio in infants, which plays an important role in preventing the poliovirus spread. Here, we analyzed mucosal immunity against poliovirus in the intestine during different sequential vaccination schedules. We conducted clinical trials in Guangxi Province, China on 1,200 2-month-old infants who were randomly assigned to one of three vaccination schedule groups: IPV-bOPV-bOPV, IPV-IPV-tOPV, and IPV-IPV-bOPV, with vaccine doses administered at 8, 12, and 16 weeks of age. Stool samples were collected from 10% of participants in each group before administration of the second vaccine doses and at 1, 2, and 4 weeks after the administrations of the second and third vaccine doses. Immunoglobulin A (IgA) in the stool samples was measured to analyze the mucosal immune response in the intestine. Because of the absence of poliovirus type 2 in bOPV, the vaccination schedule of IPV-IPV-bOPV did not sufficiently raise intestinal mucosal immunity against poliovirus type 2, although some cross-immunity was seen. The level of intestinal mucosal immunity was related to shedding status; shedders could produce intestinal mucosa IgA more quickly. The intestinal mucosal immunity level was not related to serum neutralizing antibody level. In the combined sequential vaccination schedule of IPV and bOPV, the risk of circulating vaccine-derived poliovirus type 2 (cVDPV2) may be increased owing to insufficient intestinal mucosal immunity against poliovirus type 2.
Topics: Antibodies, Viral; China; Humans; Immunity, Mucosal; Immunization Schedule; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral
PubMed: 33848232
DOI: 10.1080/21645515.2021.1911213 -
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 -
Human Vaccines & Immunotherapeutics Jan 2021: Immune immaturity may put premature infants at increased risk for infections. DTaP-IPV-Hib-HepB vaccine (Vaxelis™), a hexavalent vaccine studied in >6,800 children,...
: Immune immaturity may put premature infants at increased risk for infections. DTaP-IPV-Hib-HepB vaccine (Vaxelis™), a hexavalent vaccine studied in >6,800 children, has acceptable safety and immunogenicity profiles generally similar to control vaccines. Here we evaluate safety and immunogenicity of DTaP-IPV-Hib-HepB vaccine in premature infants. : Premature infants were identified using prior medical conditions terms "premature baby/delivery" and/or "low birth weight baby". Immunogenicity and safety data were summarized across one Phase II and four Phase III randomized, active-comparator-controlled clinical trials (Protocol 004 in Canada [Control: PENTACEL™]; Protocols 005 and 006 in the US [Control: PENTACEL™]; and Protocols 007 and 008 in the EU [Control: INFANRIX™ hexa]) and one Phase III clinical trial in the UK (PRI01C); no formal statistical comparisons were performed. : Overall, 160 infants were considered premature (DTaP-IPV-Hib-HepB = 111 Control = 49). The incidence of adverse events (AEs) for DTaP-IPV-Hib-HepB was comparable between overall and premature populations for all AEs days 1-15 postvaccination (Overall = 96.3%; Premature = 97.3%;), solicited injection-site AEs days 1-5 postvaccination (Overall = 84.1%; Premature = 75.5%), and solicited systemic AEs days 1-5 postvaccination (Overall = 93.7%; Premature = 94.5%). A high percentage of premature infants mounted protective immune responses to antigens contained in DTaP-IPV-Hib-HepB vaccine. Response rates in preterm infants for all antigens (80-99%) were in a similar range to all infants (80-99%) for both DTaP-IPV-Hib-HepB and control vaccines. : DTaP-IPV-Hib-HepB vaccine has a low incidence of AEs, an acceptable safety profile, and elicited satisfactory immune responses in premature infants comparable to the overall study population. These findings support vaccination with DTaP-IPV-Hib-HepB vaccine in healthy premature infants.
Topics: Antibodies, Bacterial; Canada; Child; Diphtheria-Tetanus-Pertussis Vaccine; Haemophilus Vaccines; Haemophilus influenzae type b; Hepatitis B Vaccines; Humans; Infant; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Poliovirus Vaccine, Inactivated; Vaccines, Combined
PubMed: 32750261
DOI: 10.1080/21645515.2020.1756668 -
Vaccine Feb 2018Infants with history of prematurity (<37 weeks gestation) and low birth weight (LBW, <2500 g) are at high risk of infection due to functional immaturity of normal... (Review)
Review
Immunization of preterm infants with GSK's hexavalent combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine: A review of safety and immunogenicity.
BACKGROUND
Infants with history of prematurity (<37 weeks gestation) and low birth weight (LBW, <2500 g) are at high risk of infection due to functional immaturity of normal physical and immunological defense mechanisms. Despite current recommendations that infants with history of prematurity/LBW should receive routine immunization according to the same schedule and chronological age as full-term infants, immunization is often delayed.
METHODS
Here we summarize 10 clinical studies and 15 years of post-marketing safety surveillance of GSK's hexavalent vaccine (DTPa-HBV-IPV/Hib), a combined diphtheria-tetanus-acellular-pertussis-hepatitis-B-inactivated-poliovirus-Haemophilus influenzae-type-b (Hib) conjugate vaccine, when administered alone, or co-administered with pneumococcal conjugate, rotavirus, and meningococcal vaccines and respiratory syncytial virus IgG to infants with history of prematurity/LBW in clinical trials.
RESULTS
At least 92.5% of infants with history of prematurity/LBW as young as 24 weeks gestation in clinical studies were seropositive to all vaccine antigens after 3-dose primary vaccination with GSK's hexavalent DTPa-HBV-IPV/Hib vaccine, with robust immune responses to booster vaccination. Seropositivity rates and antibody concentrations to hepatitis B and Hib appeared lower in infants with history of prematurity/LBW than term infants. Between 13-30% of medically stable infants with history of prematurity developed apnea after vaccination with GSK's hexavalent DTPa-HBV-IPV/Hib vaccine; usually after dose 1. The occurrence of post-immunization cardiorespiratory events appears to be influenced by the severity of any underlying neonatal condition. Most cardiorespiratory events resolve spontaneously or require minimal intervention. GSK's hexavalent DTPa-HBV-IPV/Hib vaccine was well tolerated in co-administration regimens.
CONCLUSION
GSK's hexavalent DTPa-HBV-IPV/Hib vaccine alone or co-administered with other pediatric vaccines has a clinically acceptable safety and immunogenicity profile when used in infants with history of prematurity/LBW for primary and booster vaccination. Additional studies are needed in very premature and very LBW infants. However, currently available data support using GSK's hexavalent DTPa-HBV-IPV/Hib vaccine to immunize infants with history of prematurity/LBW according to chronological age.
Topics: Diphtheria-Tetanus-Pertussis Vaccine; Global Health; Haemophilus Vaccines; Hepatitis B Vaccines; Humans; Immunity, Cellular; Immunogenicity, Vaccine; Infant; Infant, Newborn; Infant, Premature; Morbidity; Mortality; Outcome Assessment, Health Care; Poliovirus Vaccine, Inactivated; Product Surveillance, Postmarketing; Public Health Surveillance; Vaccination; Vaccines, Combined; Vaccines, Conjugate
PubMed: 29336924
DOI: 10.1016/j.vaccine.2018.01.005 -
The Journal of Infectious Diseases Sep 2022Primary intestinal immunity through viral replication of live oral vaccine is key to interrupt poliovirus transmission. We assessed viral fecal shedding from infants...
Fecal Shedding of 2 Novel Live Attenuated Oral Poliovirus Type 2 Vaccine Candidates by Healthy Infants Administered Bivalent Oral Poliovirus Vaccine/Inactivated Poliovirus Vaccine: 2 Randomized Clinical Trials.
BACKGROUND
Primary intestinal immunity through viral replication of live oral vaccine is key to interrupt poliovirus transmission. We assessed viral fecal shedding from infants administered Sabin monovalent poliovirus type 2 vaccine (mOPV2) or low and high doses of 2 novel OPV2 (nOPV2) vaccine candidates.
METHODS
In 2 randomized clinical trials in Panama, a control mOPV2 study (October 2015 to April 2016) and nOPV2 study (September 2018 to October 2019), 18-week-old infants vaccinated with bivalent oral poliovirus vaccine/inactivated poliovirus vaccine received 1 or 2 study vaccinations 28 days apart. Stools were assessed for poliovirus RNA by polymerase chain reaction (PCR) and live virus by culture for 28 days postvaccination.
RESULTS
Shedding data were available from 621 initially reverse-transcription PCR-negative infants (91 mOPV2, 265 nOPV2-c1, 265 nOPV2-c2 recipients). Seven days after dose 1, 64.3% of mOPV2 recipients and 31.3%-48.5% of nOPV2 recipients across groups shed infectious type 2 virus. Respective rates 7 days after dose 2 decreased to 33.3% and 12.9%-22.7%, showing induction of intestinal immunity. Shedding of both nOPV2 candidates ceased at similar or faster rates than mOPV2.
CONCLUSIONS
Viral shedding of either nOPV candidate was similar or decreased relative to mOPV2, and all vaccines showed indications that the vaccine virus was replicating sufficiently to induce primary intestinal mucosal immunity.
Topics: Antibodies, Viral; Humans; Infant; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Randomized Controlled Trials as Topic; Vaccines, Attenuated
PubMed: 34610135
DOI: 10.1093/infdis/jiab507 -
BMC Public Health Oct 2022Arizona's Health Start Program is a statewide community health worker (CHW) maternal and child health home visiting intervention. The objective of this study was to test...
BACKGROUND
Arizona's Health Start Program is a statewide community health worker (CHW) maternal and child health home visiting intervention. The objective of this study was to test if participation in Health Start during 2006-2016 improved early childhood vaccination completion rates.
METHODS
This retrospective study used 11 years of administrative, birth certificate, and immunization records. Propensity score matching was used to identify control groups, based on demographic, socioeconomic, and geographic characteristics. Results are reported by historically disadvantaged subgroups and/or with a history of low vaccine uptake, including Hispanic/Latinx and American Indian children, and children of low socioeconomic status and from rural areas, children with teen mothers and first-born children. The average treatment-on-the-treated (ATT) effect estimated the impact of Health Start on timely completion of seven early childhood vaccine series: diphtheria/tetanus toxoids and acellular/whole-cell pertussis (DTaP/DTP), Haemophilus influenzae type b (Hib), hepatitis B (Hep. B), measles-mumps-rubella (MMR), pneumococcal conjugate vaccine (PCV13), poliovirus, and varicella.
RESULTS
Vaccination completion rates (by age five) were 5.0% points higher for Health Start children as a group, and on average 5.0% points higher for several subgroups of mothers: women from rural border counties (ATT 5.8), Hispanic/Latinx women (ATT 4.8), American Indian women (ATT 4.8), women with less than high school education (ATT 5.0), teen mothers (ATT 6.1), and primipara women (ATT 4.5), compared to matched control groups (p-value ≤ 0.05). Time-to-event analyses show Health Start children complete vaccination sooner, with a hazard rate for full vaccination 13% higher than their matches.
CONCLUSION
A state-operated home visiting intervention with CHWs as the primary interventionist can effectively promote early childhood vaccine completion, which may reduce the incidence of preventable diseases and subsequently improve children's health. Effects of CHW interventions on vaccination uptake is particularly relevant given the rise in vaccine-preventable diseases in the US and globally.
TRIAL REGISTRATION
Approved by the University of Arizona Research Institutional Review Board (Protocol 1701128802), 25 January 2017.
Topics: Adolescent; Child; Child, Preschool; Community Health Workers; Diphtheria-Tetanus-Pertussis Vaccine; Female; Haemophilus Vaccines; Humans; Infant; Poliovirus Vaccine, Inactivated; Propensity Score; Retrospective Studies; Vaccination; Vaccines, Combined; Vaccines, Conjugate
PubMed: 36195944
DOI: 10.1186/s12889-022-14239-w -
The Lancet. Infectious Diseases Feb 2022Expanding outbreaks of circulating vaccine-derived type 2 poliovirus (cVDPV2) across Africa after the global withdrawal of trivalent oral poliovirus vaccine (OPV) in...
Risk factors for the spread of vaccine-derived type 2 polioviruses after global withdrawal of trivalent oral poliovirus vaccine and the effects of outbreak responses with monovalent vaccine: a retrospective analysis of surveillance data for 51 countries in Africa.
BACKGROUND
Expanding outbreaks of circulating vaccine-derived type 2 poliovirus (cVDPV2) across Africa after the global withdrawal of trivalent oral poliovirus vaccine (OPV) in 2016 are delaying global polio eradication. We aimed to assess the effect of outbreak response campaigns with monovalent type 2 OPV (mOPV2) and the addition of inactivated poliovirus vaccine (IPV) to routine immunisation.
METHODS
We used vaccination history data from children under 5 years old with non-polio acute flaccid paralysis from a routine surveillance database (the Polio Information System) and setting-specific OPV immunogenicity data from the literature to estimate OPV-induced and IPV-induced population immunity against type 2 poliomyelitis between Jan 1, 2015, and June 30, 2020, for 51 countries in Africa. We investigated risk factors for reported cVDPV2 poliomyelitis including population immunity, outbreak response activities, and correlates of poliovirus transmission using logistic regression. We used the model to estimate cVDPV2 risk for each 6-month period between Jan 1, 2016, and June 30, 2020, with different numbers of mOPV2 campaigns and compared the timing and location of actual mOPV2 campaigns and the number of mOPV2 campaigns required to reduce cVDPV2 risk to low levels.
FINDINGS
Type 2 OPV immunity among children under 5 years declined from a median of 87% (IQR 81-93) in January-June, 2016 to 14% (9-37) in January-June, 2020. Type 2 immunity from IPV among children under 5 years increased from 3% (<1-6%) in January-June, 2016 to 35% (24-47) in January-June, 2020. The probability of cVDPV2 poliomyelitis among children under 5 years was negatively correlated with OPV-induced and IPV-induced immunity and mOPV2 campaigns (adjusted odds ratio: OPV 0·68 [95% CrI 0·60-0·76], IPV 0·82 [0·68-0·99] per 10% absolute increase in estimated population immunity, mOPV2 0·30 [0·20-0·44] per campaign). Vaccination campaigns in response to cVDPV2 outbreaks have been smaller and slower than our model shows would be necessary to reduce risk to low levels, covering only 11% of children under 5 years who are predicted to be at risk within 6 months and only 56% within 12 months.
INTERPRETATION
Our findings suggest that as mucosal immunity declines, larger or faster responses with vaccination campaigns using type 2-containing OPV will be required to stop cVDPV2 transmission. IPV-induced immunity also has an important role in reducing the burden of cVDPV2 poliomyelitis in Africa.
FUNDING
Bill & Melinda Gates Foundation, Medical Research Council Centre for Global Infectious Disease Analysis, and WHO.
TRANSLATION
For the French translation of the abstract see Supplementary Materials section.
Topics: Child; Child, Preschool; Disease Outbreaks; Humans; Poliomyelitis; Poliovirus; Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Retrospective Studies; Risk Factors
PubMed: 34648733
DOI: 10.1016/S1473-3099(21)00453-9 -
Journal of Medical Virology Feb 2020The number of new and improved human viral vaccines licensed in recent years contrasts sharply with what could be termed the golden era (1955-1990) when vaccines against... (Review)
Review
The number of new and improved human viral vaccines licensed in recent years contrasts sharply with what could be termed the golden era (1955-1990) when vaccines against polio-, measles, mumps, rubella, and hepatitis B viruses first became available. Here, we attempt to explain why vaccines, mainly against viruses other than human immunodeficiency virus and hepatitis C virus, are still unavailable. They include human herpesviruses other than varicella-zoster virus, respiratory syncytial and most other respiratory, enteric and arthropod-borne viruses. Improved oral poliovirus vaccines are also urgently required. Their unavailability is attributable to regulatory/economic factors and the properties of individual viruses, but also to an absence of relevant animal models and ethical problems for the conduct of clinical of trials in pediatric and other critical populations. All are portents of likely difficulties for the licensing of effective vaccines against emerging pathogens, such as avian influenza, Ebola, and Zika viruses.
Topics: Animals; Antibodies, Viral; Chickenpox Vaccine; Clinical Trials as Topic; Dengue Vaccines; Disease Models, Animal; Ebola Vaccines; Humans; Influenza Vaccines; Measles-Mumps-Rubella Vaccine; Poliovirus Vaccine, Oral; Rotavirus Vaccines; Viral Vaccines; Virus Diseases; Zika Virus
PubMed: 31502669
DOI: 10.1002/jmv.25593 -
Human Vaccines & Immunotherapeutics 2019In 2002, the WHO European Region was declared polio-free. Nonetheless global eradication has not yet been completed and the reintroduction from at risk areas is still...
In 2002, the WHO European Region was declared polio-free. Nonetheless global eradication has not yet been completed and the reintroduction from at risk areas is still possible. This seroprevalence study evaluated samples collected from each Italian region in the 12-50 years old age range to assess protection against Poliovirus (PV) 1, 2 and 3 among subjects immunised with different vaccination schedules. 1073 samples (50.5% females) were examined. WHO standardized microneutralization assay was used. Seroprotection rates were 92.9%, 96.2% and 83.4%, for PV1, PV2 and PV3, respectively. Geometric Mean Titres (GMTs) were higher for PV2 (52.8) and PV1 (41.1) than for PV3 (21.0). Increasing the age, a decreasing trend in seropositivity was observed, in particular for PV3. The 2017-2019 Italian National Immunisation Plan emphasises, as primary objective, the maintenance of the polio-free status and strongly validates the 2 + 1 schedule in the first year of life with IPV vaccine associated with the administration of booster doses at 6 years and during the adolescence. Surveillance system and high population immunity are crucial to ensure the maintenance of polio-free status.
Topics: Adolescent; Adult; Antibodies, Neutralizing; Antibodies, Viral; Child; Disease Eradication; Disease Outbreaks; Female; Humans; Immunization Schedule; Immunization, Secondary; Italy; Male; Middle Aged; Neutralization Tests; Poliomyelitis; Poliovirus; Poliovirus Vaccines; Seroepidemiologic Studies; Young Adult
PubMed: 30427738
DOI: 10.1080/21645515.2018.1547608 -
Clinical Microbiology and Infection :... Dec 2016During 2013/14, Israel witnessed the silent reintroduction and sustained transmission of wild poliovirus type 1 (WPV1) detected through routine environmental... (Review)
Review
During 2013/14, Israel witnessed the silent reintroduction and sustained transmission of wild poliovirus type 1 (WPV1) detected through routine environmental surveillance performed on sewage samples. The public health response to silent poliovirus transmission in a population with high inactivated polio vaccine (IPV) coverage poses an emerging challenge towards the 'End Game' of global poliovirus eradication. This paper reviews the risk assessment, risk management and risk communication aspects of this poliovirus incident. Special emphasis is placed on the use of scientific data generated in the risk assessment phase to inform the public health response. Reintroducing a live vaccine in supplemental immunization activities in response to transmission of WPV or vaccine-derived poliovirus should be considered close to the 'End Game' of polio eradication, especially if targeting the population at risk is feasible. Such circumstances require a comprehensive contingency plan that will support the generation of important public health evidence at the risk assessment stage, thereby allowing to tailor the risk management approaches and underpin appropriate risk communication.
Topics: Communicable Disease Control; Humans; Israel; Poliomyelitis; Poliovirus; Poliovirus Vaccines; Public Health Administration
PubMed: 28034372
DOI: 10.1016/j.cmi.2016.06.018