Asunto(s)
Vacunas contra Haemophilus , Vacunas contra Hepatitis B , Padres , Vacuna Antipolio de Virus Inactivados , Humanos , China , Vacunas contra Haemophilus/economía , Vacunas contra Hepatitis B/economía , Vacunas contra Hepatitis B/administración & dosificación , Estudios Transversales , Padres/psicología , Vacuna Antipolio de Virus Inactivados/economía , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacunas Combinadas/economía , Aceptación de la Atención de Salud/psicología , Encuestas y Cuestionarios , Vacunación/economía , Vacunación/psicología , Vacuna contra Difteria, Tétanos y Tos Ferina/economía , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , LactanteRESUMEN
BACKGROUND: "Zero-dose" children are those who are without any routine vaccination or are lacking the first dose of the diphtheria, tetanus, and pertussis-containing vaccine. Based on global estimates from the World Health Organization/United Nations Children's Fund in 2022, Nigeria has the highest number of zero-dose children, with >2.3 million unvaccinated. METHODS: We used data from the 2021 Nigeria Multiple Indicator Cluster Survey/National Immunization Coverage Survey to identify zero-dose and underimmunized children. Geospatial modeling techniques were employed to determine the prevalence of zero-dose children and predict risk areas with underimmunized children at a high resolution (1 × 1â km). RESULTS: Zero-dose and underimmunized children are more prevalent in socially deprived groups. Univariate and multivariate bayesian analyses showed positive correlations between the prevalence of zero-dose and underimmunized children and factors such as stunting, contraceptive prevalence, and literacy. The prevalence of zero-dose and underimmunized children varies significantly by region and ethnicity, with higher rates observed in the country's northern parts. Significant heterogeneity in the distribution of undervaccinated children was observed. CONCLUSIONS: Nigeria needs to enhance its immunization system and coverage. Geospatial modeling can help deliver vaccines effectively to underserved communities. By adopting this approach, countries can ensure equitable vaccine access and contribute to global vaccination objectives.
Asunto(s)
Cobertura de Vacunación , Humanos , Nigeria/epidemiología , Lactante , Cobertura de Vacunación/estadística & datos numéricos , Femenino , Masculino , Preescolar , Teorema de Bayes , Programas de Inmunización , Vacunación/estadística & datos numéricos , Prevalencia , Niño , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificaciónRESUMEN
Bordetella pertussis is a Gram-negative bacterium that is the causative agent of the respiratory disease known as pertussis. Since the switch to the acellular vaccines of DTaP and Tap, pertussis cases in the US have risen and cyclically fallen. We have observed that mRNA pertussis vaccines are immunogenic and protective in mice. Here, we further evaluated the pertussis toxoid mRNA antigen and refined the formulation based on optimal pertussis toxin neutralization in vivo. We next evaluated the mRNA pertussis vaccine in Sprague-Dawley rats using an aerosol B. pertussis challenge model paired with whole-body plethysmography to monitor coughing and respiratory function. Female Sprague-Dawley rats were primed and boosted with either commercially available vaccines (DTaP or wP-DTP), an mRNA-DTP vaccine, or mock-vaccinated. The mRNA-DTP vaccine was immunogenic in rats and induced antigen-specific IgG antibodies comparable to DTaP. Rats were then aerosol challenged with a streptomycin-resistant emerging clinical isolate D420Sm1. Bacterial burden was assessed at days 1 and 9 post-challenge, and the mRNA vaccine reduced burden equal to both DTaP and wP-DTP. Whole-body plethysmography revealed that mRNA-DTP vaccinated rats were well protected against coughing which was comparable to the non-challenged group. These data suggest that an mRNA-DTP vaccine is immunogenic in rats and provides protection against aerosolized B. pertussis challenge in Sprague-Dawley rats.
Asunto(s)
Bordetella pertussis , Ratas Sprague-Dawley , Tos Ferina , Animales , Tos Ferina/prevención & control , Tos Ferina/inmunología , Femenino , Ratas , Bordetella pertussis/inmunología , Bordetella pertussis/genética , Anticuerpos Antibacterianos/sangre , Anticuerpos Antibacterianos/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Inmunoglobulina G/sangre , Vacunas de ARNm , InmunizaciónAsunto(s)
Difteria , Sistema de Registros , Tétanos , Cobertura de Vacunación , Tos Ferina , Humanos , Australia/epidemiología , Cobertura de Vacunación/estadística & datos numéricos , Anciano , Femenino , Masculino , Difteria/prevención & control , Difteria/epidemiología , Tos Ferina/prevención & control , Tos Ferina/epidemiología , Tétanos/prevención & control , Tétanos/epidemiología , Anciano de 80 o más Años , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Toxoide Tetánico/administración & dosificación , Vacuna contra la Tos Ferina/administración & dosificaciónRESUMEN
To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas contra Haemophilus , Vacuna Antipolio de Virus Inactivados , Vacunas Combinadas , Humanos , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Haemophilus/administración & dosificación , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Lactante , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/administración & dosificación , China/epidemiología , Femenino , Masculino , Vacunación/efectos adversos , Infecciones por Haemophilus/prevención & control , Esquemas de Inmunización , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificaciónRESUMEN
BACKGROUND: In many countries, infant vaccination with acellular pertussis (aP) vaccines has replaced use of more reactogenic whole-cell pertussis (wP) vaccines. Based on immunological and epidemiological evidence, we hypothesised that substituting the first aP dose in the routine vaccination schedule with wP vaccine might protect against IgE-mediated food allergy. We aimed to compare reactogenicity, immunogenicity, and IgE-mediated responses of a mixed wP/aP primary schedule versus the standard aP-only schedule. METHODS AND FINDINGS: OPTIMUM is a Bayesian, 2-stage, double-blind, randomised trial. In stage one, infants were assigned (1:1) to either a first dose of a pentavalent wP combination vaccine (DTwP-Hib-HepB, Pentabio PT Bio Farma, Indonesia) or a hexavalent aP vaccine (DTaP-Hib-HepB-IPV, Infanrix hexa, GlaxoSmithKline, Australia) at approximately 6 weeks old. Subsequently, all infants received the hexavalent aP vaccine at 4 and 6 months old as well as an aP vaccine at 18 months old (DTaP-IPV, Infanrix-IPV, GlaxoSmithKline, Australia). Stage two is ongoing and follows the above randomisation strategy and vaccination schedule. Ahead of ascertainment of the primary clinical outcome of allergist-confirmed IgE-mediated food allergy by 12 months old, here we present the results of secondary immunogenicity, reactogenicity, tetanus toxoid IgE-mediated immune responses, and parental acceptability endpoints. Serum IgG responses to diphtheria, tetanus, and pertussis antigens were measured using a multiplex fluorescent bead-based immunoassay; total and specific IgE were measured in plasma by means of the ImmunoCAP assay (Thermo Fisher Scientific). The immunogenicity of the mixed schedule was defined as being noninferior to that of the aP-only schedule using a noninferiority margin of 2/3 on the ratio of the geometric mean concentrations (GMR) of pertussis toxin (PT)-IgG 1 month after the 6-month aP. Solicited adverse reactions were summarised by study arm and included all children who received the first dose of either wP or aP. Parental acceptance was assessed using a 5-point Likert scale. The primary analyses were based on intention-to-treat (ITT); secondary per-protocol (PP) analyses were also performed. The trial is registered with ANZCTR (ACTRN12617000065392p). Between March 7, 2018 and January 13, 2020, 150 infants were randomised (75 per arm). PT-IgG responses of the mixed schedule were noninferior to the aP-only schedule at approximately 1 month after the 6-month aP dose [GMR = 0·98, 95% credible interval (0·77 to 1·26); probability (GMR > 2/3) > 0·99; ITT analysis]. At 7 months old, the posterior median probability of quantitation for tetanus toxoid IgE was 0·22 (95% credible interval 0·12 to 0·34) in both the mixed schedule group and in the aP-only group. Despite exclusions, the results were consistent in the PP analysis. At 6 weeks old, irritability was the most common systemic solicited reaction reported in wP (65 [88%] of 74) versus aP (59 [82%] of 72) vaccinees. At the same age, severe systemic reactions were reported among 14 (19%) of 74 infants after wP and 8 (11%) of 72 infants after aP. There were 7 SAEs among 5 participants within the first 6 months of follow-up; on blinded assessment, none were deemed to be related to the study vaccines. Parental acceptance of mixed and aP-only schedules was high (71 [97%] of 73 versus 69 [96%] of 72 would agree to have the same schedule again). CONCLUSIONS: Compared to the aP-only schedule, the mixed schedule evoked noninferior PT-IgG responses, was associated with more severe reactions, but was well accepted by parents. Tetanus toxoid IgE responses did not differ across the study groups. TRIAL REGISTRATION: Trial registered at the Australian and New Zealand Clinical 207 Trial Registry (ACTRN12617000065392p).
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina , Esquemas de Inmunización , Inmunoglobulina E , Humanos , Lactante , Método Doble Ciego , Inmunoglobulina E/inmunología , Inmunoglobulina E/sangre , Femenino , Masculino , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Australia , Vacunas Combinadas/inmunología , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/administración & dosificación , Vacuna contra la Tos Ferina/inmunología , Vacuna contra la Tos Ferina/efectos adversos , Vacuna contra la Tos Ferina/administración & dosificación , Hipersensibilidad a los Alimentos/inmunología , Hipersensibilidad a los Alimentos/prevención & control , Vacuna Antipolio de Virus Inactivados/inmunología , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacunas contra Haemophilus/inmunología , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Haemophilus/administración & dosificación , Tos Ferina/prevención & control , Tos Ferina/inmunología , Inmunogenicidad Vacunal , Anticuerpos Antibacterianos/sangre , Anticuerpos Antibacterianos/inmunologíaRESUMEN
Childhood vaccinations are among the most cost-effective health interventions. Yet, in India, where immunisation services are widely available free of charge, a substantial proportion of children remain unvaccinated. We revisit households 30 months after a randomised experiment of a health information intervention designed to educate mothers on the benefits of child vaccination in Uttar Pradesh, India. We find that the large short-term effects on the uptake of diphtheria-pertussis-tetanus and measles vaccination were sustained at 30 months, suggesting the intervention did not simply bring forward vaccinations. We apply causal forests and find that the intervention increased vaccination uptake, but that there was substantial variation in the magnitude of the estimated effects. We conclude that characterising those who benefited most and conversely those who benefited least provides policy-makers with insights on how the intervention worked, and how the targeting of households could be improved.
Asunto(s)
Madres , Humanos , India , Madres/educación , Femenino , Lactante , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Educación en Salud , Preescolar , Adulto , Masculino , Vacunación/estadística & datos numéricos , Programas de Inmunización , Vacuna Antisarampión/administración & dosificaciónRESUMEN
Urban children are more likely to be vaccinated than rural children, but that advantage is not evenly distributed. Children living in poor urban areas face unique challenges, living far from health facilities and with lower-quality health services, which can impact their access to life-saving vaccines. Our goal was to compare the prevalence of zero-dose children in poor and non-poor urban and rural areas of low- and middle-income countries (LMICs). Zero-dose children were those who failed to receive any dose of a diphtheria-pertussis-tetanus (DPT) containing vaccine. We used data from nationally representative household surveys of 97 LMICs to investigate 201,283 children aged 12-23 months. The pooled prevalence of zero-dose children was 6.5% among the urban non-poor, 12.6% for the urban poor, and 14.7% for the rural areas. There were significant differences between these areas in 43 countries. In most of these countries, the non-poor urban children were at an advantage compared to the urban poor, who were still better off or similar to rural children. Our results emphasize the inequalities between urban and rural areas, but also within urban areas, highlighting the challenges faced by poor urban and rural children. Outreach programs and community interventions that can reach poor urban and rural communities-along with strengthening of current vaccination programs and services-are important steps to reduce inequalities and ensure that no child is left unvaccinated.
Asunto(s)
Países en Desarrollo , Accesibilidad a los Servicios de Salud , Población Rural , Población Urbana , Humanos , Lactante , Población Rural/estadística & datos numéricos , Población Urbana/estadística & datos numéricos , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Femenino , Masculino , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Pobreza , Cobertura de Vacunación/estadística & datos numéricos , Programas de Inmunización/estadística & datos numéricos , PrevalenciaRESUMEN
Bone marrow plasma cells (BMPC) are the correlate of humoral immunity, consistently releasing antibodies into the bloodstream. It remains unclear if BMPC reflect different activation environments or maturation of their precursors. Here we define human BMPC heterogeneity and track the recruitment of antibody-secreting cells (ASC) from SARS-CoV-2 vaccine immune reactions to the bone marrow (BM). Trajectories based on single-cell transcriptomes and repertoires of peripheral and BM ASC reveal sequential colonisation of BMPC compartments. In activated B cells, IL-21 suppresses CD19 expression, indicating that CD19low-BMPC are derived from follicular, while CD19high-BMPC originate from extrafollicular immune reactions. In primary immune reactions, both CD19low- and CD19high-BMPC compartments are populated. In secondary immune reactions, most BMPC are recruited to CD19high-BMPC compartments, reflecting their origin from extrafollicular reactivations of memory B cells. A pattern also observable in vaccinated-convalescent individuals and upon diphtheria/tetanus/pertussis recall-vaccination. Thus, BMPC diversity reflects the evolution of a given humoral immune response.
Asunto(s)
Antígenos CD19 , Médula Ósea , Interleucinas , Células Plasmáticas , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Células Productoras de Anticuerpos/inmunología , Antígenos CD19/inmunología , Antígenos CD19/metabolismo , Linfocitos B/inmunología , Médula Ósea/inmunología , Células de la Médula Ósea/inmunología , Células de la Médula Ósea/citología , COVID-19/inmunología , COVID-19/virología , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Inmunidad Humoral/inmunología , Interleucinas/inmunología , Interleucinas/metabolismo , Células Plasmáticas/inmunología , SARS-CoV-2/inmunología , Análisis de la Célula Individual , VacunaciónRESUMEN
BACKGROUND AND OBJECTIVES: Ensuring equitable vaccination access for immigrant communities is critical for guiding efforts to redress health disparities, but vaccine coverage data are limited. We evaluated childhood vaccination coverage by parental birth country (PBC) through the linkage of Washington State Immunization Information System data and birth records. METHODS: We conducted a retrospective cohort evaluation of children born in Washington from January 1, 2006 to November 12, 2019. We assessed up-to-date vaccination coverage status for measles, mumps, and rubella (MMR), diphtheria, tetanus, and pertussis (DTaP), and poliovirus vaccines at ages 36 months and 7 years. Children with ≥1 parent(s) born in selected non-US countries were compared with children with 2 US-born parents, using Poisson regression models to provide prevalence ratios. RESULTS: We identified 902 909 eligible children, of which 24% had ≥1 non-US-born parent(s). Vaccination coverage at 36 months by PBC ranged from 41.0% to 93.2% for ≥1 MMR doses and ≥3 poliovirus doses and 32.6% to 86.4% for ≥4 DTaP doses. Compared with children of US-born parents, the proportion of children up to date for all 3 vaccines was 3% to 16% higher among children of Filipino-, Indian-, and Mexican-born parents and 33% to 56% lower among children of Moldovan-, Russian-, and Ukrainian-born parents. Within-PBC coverage patterns were similar for all vaccines with some exceptions. Similar PBC-level differences were observed at 7 years of age. CONCLUSIONS: The linkage of public health data improved the characterization of community-level childhood immunization outcomes. The findings provide actionable information to understand community-level vaccination determinants and support interventions to enhance vaccine coverage.
Asunto(s)
Emigrantes e Inmigrantes , Cobertura de Vacunación , Humanos , Cobertura de Vacunación/estadística & datos numéricos , Washingtón , Estudios Retrospectivos , Preescolar , Femenino , Masculino , Niño , Emigrantes e Inmigrantes/estadística & datos numéricos , Vacuna contra el Sarampión-Parotiditis-Rubéola/administración & dosificación , Padres , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificaciónRESUMEN
Globally dropout rate for the three dose of penta (DPT) vaccine was highest in the African region. This mainly occurred in the African Region including Ethiopia. Despite high national incomplete vaccination status, there is lack of study on the determinants of incomplete vaccination in south west region, Ethiopia. Therefore, this study was conducted to identify determinants of incomplete Penta vaccination among children aged 12 to 23 months in Mettu district South-West Ethiopia. A Community based case-control study was conducted from April 24, May 23, 2022 in South-west Ethiopia. Data was collected from 297 participants (99 cases and 198controls) by using simple random sampling techniques. Cases were children age from 9 to 23 months who missed at least one dose from the routine vaccine and controls were completed the entire routine vaccine schedule. Data was entered to Epi-data version 3.1 and exported to SPSS version 23 for statistical analyses. Binary and multivariable logistic regression with a 95% CI and a p-value of < 0.05 was done to declare statistical significance. A total of 95 cases and 197 controls participated in the study. Rural residence [AOR: 3.9; 95% CI; (1.6, 9.4)], wealth indexes [AOR: 3.6; 95% CI; (1.8,7.0)], mothers unimmunized tetanus toxoid [AOR: 4.3; 95% CI; (2.1, 8.6)], postponed schedule [AOR: 4.6; 95% CI; (2.4, 8.8)], un satisfied to service [AOR: 3.7; 95% CI; (1.7,7.6)] and poor perception on benefit of vaccine [AOR:2.7; 95% CI; (1.2, 6.1)] were determinants of incomplete vaccination. Rural Residence, Family wealth index of poor; Mother not received tetanus vaccination; postponed vaccination schedule client satisfaction and caretaker perception on benefit of vaccination were identified determinants of incomplete vaccination.Health information should be given for the community and child caretaker on the benefit of complete vaccination. Community should be encouraged to not post pond vaccine schedule. Pregnant women should be strengthening to receive tetanus toxoid vaccine during pregnancy.
Asunto(s)
Vacunación , Humanos , Etiopía , Femenino , Masculino , Lactante , Vacunación/estadística & datos numéricos , Estudios de Casos y Controles , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Adulto , Esquemas de Inmunización , Cobertura de Vacunación/estadística & datos numéricosRESUMEN
Thailand has incorporated the whole-cell (wP) pertussis vaccine into the expanded program on immunization since 1977 and has offered the acellular pertussis (aP) vaccine as an optional vaccine for infants since 2001. We followed healthy children from a clinical trial (ClinicalTrials.gov NCT02408926) in which children were randomly assigned to receive either pentavalent (DTwP-HB-Hib) or hexavalent (DTaP-IPV-HB-Hib) vaccines for their primary series (administered at 2, 4, and 6 months) and first booster vaccination (18 months). Both groups received Tdap-IPV as a second booster at the age of 4 y. Blood samples were collected for evaluation of antibody persistence to diphtheria toxoid (DT), tetanus toxoid (TT), and Bordetella pertussis (B. pertussis) between 2 and 6 y of age annually, and for the immunogenicity study of Tdap-IPV at 1 month after the second booster. Antibody persistence to Haemophilus influenzae type b (Hib) was followed until 3 y of age. A total of 105 hexavalent-vaccinated children and 91 pentavalent-vaccinated children completed this study. Both pentavalent and hexavalent groups demonstrated increased antibody levels against DT, TT, and B. pertussis antigens following the second booster with Tdap-IPV. All children achieved a seroprotective concentration for anti-DT and anti-TT IgG at 1 month post booster. The hexavalent group possessed significantly higher anti-pertactin IgG (adjusted p = .023), whereas the pentavalent group possessed significantly higher anti-pertussis toxin IgG (adjusted p < .001) after the second booster. Despite declining levels post-second booster, a greater number of children sustained protective levels of anti-DT and anti-TT IgG compared to those after the first booster.
Asunto(s)
Anticuerpos Antibacterianos , Bordetella pertussis , Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas contra Haemophilus , Haemophilus influenzae tipo b , Inmunización Secundaria , Vacunas Combinadas , Tos Ferina , Preescolar , Femenino , Humanos , Lactante , Masculino , Anticuerpos Antibacterianos/sangre , Bordetella pertussis/inmunología , Difteria/prevención & control , Difteria/inmunología , Toxoide Diftérico/inmunología , Toxoide Diftérico/administración & dosificación , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Infecciones por Haemophilus/prevención & control , Infecciones por Haemophilus/inmunología , Haemophilus influenzae tipo b/inmunología , Vacunas contra Haemophilus/inmunología , Vacunas contra Haemophilus/administración & dosificación , Vacuna Antipolio de Virus Inactivados/inmunología , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Toxoide Tetánico/inmunología , Toxoide Tetánico/administración & dosificación , Tailandia , Vacunas Combinadas/inmunología , Vacunas Combinadas/administración & dosificación , Tos Ferina/prevención & control , Tos Ferina/inmunología , Estudios de SeguimientoRESUMEN
Since the introduction of Haemophilus Influenzae type b (Hib) conjugate vaccines, invasive Hib disease has strongly declined worldwide, yet continued control of Hib disease remains important. In Europe, currently three different hexavalent combination vaccines containing Hib conjugates are marketed. In this phase IV, single-blind, randomized, controlled, multi-country study (NCT04535037), we aimed to compare, in a 2 + 1 vaccination schedule, the immunogenicity and safety and show non-inferiority, as well as superiority, of DTPa-HBV-IPV/Hib (Ih group) versus DTaP5-HB-IPV-Hib (Va group) in terms of anti-polyribosylribitol phosphate (PRP) antibody geometric mean concentrations (GMCs) and proportion of participants reaching anti-PRP antibody concentrations greater than or equal to a threshold of 5 µg/mL. One month after the booster vaccination, the anti-PRP antibody GMC ratio (Ih group/Va group) was 0.917 (95% CI: 0.710-1.185), meeting the non-inferiority criteria. The difference in percentage of participants (Ih group - Va group) reaching GMCs ≥5 µg/mL was -6.3% (95% CI: -14.1% to 1.5%), not reaching the predefined non-inferiority threshold. Interestingly, a slightly higher post-booster antibody avidity was observed in the Ih group versus the Va group. Both vaccines were well tolerated, and no safety concerns were raised. This study illustrates the different kinetics of the anti-PRP antibody response post-primary and post-booster using the two vaccines containing different Hib conjugates and indicates a potential differential impact of concomitant vaccinations on the anti-PRP responses. The clinical implications of these differences should be further studied.
Vaccination against Haemophilus influenzae type b (Hib) is included in the majority of national immunization programs worldwide and has shown to be effective in preventing Hib disease. In Europe, different vaccines containing Hib components are marketed. We compared the immune response and safety of 2 of these (DTPa-HBV-IPV/Hib, Ih group) and DTaP5-HB-IPV-Hib, Va group) in infants and toddlers, when used in a 2 + 1 schedule, i.e. two primary vaccination doses (at 2 and 4 months of age of the infant), followed by one booster dose at the age of one year. One month after the booster vaccination, the antibody concentration ratio between both groups (Ih group/Va group) was 0.917 (95% CI: 0.7101.185) showing the DTPa-HBV-IPV/Hib vaccine was non-inferior to the DTaP5-HB-IPV-Hib vaccine; the difference in percentage of participants (Ih group Va group) with antibody concentrations above 5 µg/mL was -6.3% (95% CI: −14.1% to 1.5%), which did not meet the pre-defined criterion for non-inferiority. In the Ih group, the quality of antibodies produced was somewhat higher versus the Va group. Both vaccines were well tolerated, and no safety concerns were raised. The kinetics of the immune response are different between the 2 vaccines. Since both vaccines contain different additional components (conjugated proteins), a possible effect of concomitant (simultaneously administered) vaccines was studied. Further investigations to confirm our findings are needed.
Asunto(s)
Anticuerpos Antibacterianos , Vacunas contra Haemophilus , Haemophilus influenzae tipo b , Esquemas de Inmunización , Polisacáridos , Vacunas Combinadas , Vacunas Conjugadas , Humanos , Vacunas contra Haemophilus/inmunología , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Haemophilus/administración & dosificación , Anticuerpos Antibacterianos/sangre , Lactante , Femenino , Masculino , Método Simple Ciego , Vacunas Conjugadas/inmunología , Vacunas Conjugadas/administración & dosificación , Vacunas Conjugadas/efectos adversos , Haemophilus influenzae tipo b/inmunología , Vacunas Combinadas/inmunología , Vacunas Combinadas/administración & dosificación , Vacunas Combinadas/efectos adversos , Infecciones por Haemophilus/prevención & control , Infecciones por Haemophilus/inmunología , Vacunas contra Hepatitis B/inmunología , Vacunas contra Hepatitis B/administración & dosificación , Vacunas contra Hepatitis B/efectos adversos , Vacuna Antipolio de Virus Inactivados/inmunología , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Preescolar , Inmunogenicidad Vacunal , Europa (Continente)RESUMEN
DTaP-HBV-IPV-Hib hexavalent vaccine has been used in high-income countries for many years to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive Haemophilus influenzae type b disease. Currently, no hexavalent vaccines have been approved for use in China. Evidence of parental acceptance and interest in hexavalent vaccines can help policy makers and manufacturers make decisions about entering the vaccine market and the immunization program in China. We measured parental acceptance and willingness-to-pay (WTP) for a hexavalent vaccine to provide such evidence. We conducted a cross-sectional survey of children's caregivers in 16 vaccination clinics in seven cities in China and obtained information on socio-demographics, knowledge of disease, confidence in vaccines, previous vaccination experience, and acceptance of and WTP for hexavalent vaccine. Multivariate logistic regression was used to determine factors influencing acceptance, and multivariate tobit regression was used to identify factors impacting WTP. Between April 28 and June 30, 2023, a total of 581 parents of children aged 0-6 years participated in the survey; 435 (74.87%, 95% CI:71.3%-78.4%) parents indicated acceptance of hexavalent vaccine. Residence location, parents' education level, experience paying for vaccination, and disease knowledge scores were key factors affecting parents' choices for vaccination. Mean (SD) and median (IQR) willingness to pay for full 4-dose course vaccination were 2266.66 (1177.1) CNY and 2400 (1600-2800) CNY. Children's age (p < .001), parents' education level (p = .024), and perceived price barriers (p < .001) were significantly associated with WTP. Parents have high acceptance and willingness to pay for hexavalent vaccine. The less money parents have to pay out of pocket, the more willing they can be to accept the vaccine. Therefore, acceptance may increase even further if the vaccine is covered by medical insurance, provided free of charge by the government, or if its price is reduced. Our results provide reference for optimizing and adjusting immunization strategies in China.
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas contra Haemophilus , Haemophilus influenzae tipo b , Vacunas contra Hepatitis B , Niño , Humanos , Vacunas Combinadas , Estudios Transversales , ChinaRESUMEN
OBJECTIVE: This study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator. METHODS: This study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 µg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization. RESULTS: In 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 µg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified. CONCLUSION: A single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).
Asunto(s)
Difteria , Vacunas contra Haemophilus , Haemophilus influenzae tipo b , Poliomielitis , Tétanos , Tos Ferina , Lactante , Humanos , Japón , Tétanos/prevención & control , Difteria/prevención & control , Tos Ferina/prevención & control , Toxina Tetánica , Toxina Diftérica , Vacuna Antipolio de Virus Inactivados , Esquemas de Inmunización , Anticuerpos Antibacterianos , Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas Combinadas , Poliomielitis/prevención & control , Vacunas ConjugadasRESUMEN
Objective: To quantify the association between reduction in child mortality and routine immunization across 204 countries and territories from 1990 to 2019. Methods: We used child mortality and vaccine coverage data from the Global Burden of Disease Study. We used a modified child survival framework and applied a mixed-effects regression model to estimate the reduction in deaths in children younger than 5 years associated with eight vaccines. Findings: Between 1990 and 2019, the diphtheria-tetanus-pertussis (DTP), measles, rotavirus and Haemophilus influenzae type b vaccines were significantly associated with an estimated 86.9 (95% confidence interval, CI: 57.2 to 132.4) million fewer deaths in children younger than 5 years worldwide. This decrease represented a 24.2% (95% CI: 19.8 to 28.9) reduction in deaths relative to a scenario without vaccines. The DTP and measles vaccines averted 46.7 (95% CI: 30.0 to 72.7) million and 37.9 (95% CI: 25.4 to 56.8) million deaths, respectively. Of the total reduction in child mortality associated with vaccines, 84.2% (95% CI: 83.0 to 85.1) occurred in 73 countries supported by Gavi, the Vaccine Alliance, with an estimated 45.4 (95% CI: 29.8 to 69.2) million fewer deaths from 2000 to 2019. The largest reductions in deaths associated with these four vaccines were in India, China, Ethiopia, Pakistan and Bangladesh (in order of the size of reduction). Conclusion: Vaccines continue to reduce childhood mortality significantly, especially in Gavi-supported countries, emphasizing the need for increased investment in routine immunization programmes.
Asunto(s)
Sarampión , Tos Ferina , Niño , Humanos , Lactante , Programas de Inmunización , Vacunación , Vacuna Antisarampión/uso terapéutico , Mortalidad del Niño , Sarampión/epidemiología , Sarampión/prevención & control , Vacuna contra Difteria, Tétanos y Tos FerinaRESUMEN
Vaccination is widely considered to be one of the most important prevention measures as a health strategy. This paper examines trends in basic childhood vaccination coverage and which country and time-dependent determinants may have influenced childhood immunization rates (1-dose BCG, 1- and 3-dose DTP (diphtheria, tetanus, pertussis), 1-dose measles, and 3-dose polio) between 1980 and 2020 across 94 countries. We identify economic, inequality, demographic, health, education, labor market, environmental, and political stability factors of immunization. To do this, we use data from the annual WHO and United Nations International Children's Emergency Fund (UNICEF) coverage estimates. The empirical analysis consists of generalized estimating equation models to assess relationships between immunization rates and socioeconomic factors. Additionally, we follow the Barro and Sala-i-Martín approach to identify conditional convergence. Our findings show the strongest positive statistically significant association between immunization rates and GDP per capita, as well as births attended by skilled health staff. Moreover, our research demonstrates conditional convergence, indicating that countries converge towards different steady states. The present study brings new insights to investigating the determinants of childhood vaccination coverage and provides significant implications for health policies.
Asunto(s)
Programas de Inmunización , Cobertura de Vacunación , Niño , Humanos , Lactante , Vacunación , Inmunización , Factores Socioeconómicos , Vacuna contra Difteria, Tétanos y Tos FerinaRESUMEN
DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Switching between HVs during the childhood vaccination series is sometimes necessary due to, for example, vaccine availability, health-care provider preference, and/or tender awards. The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. Healthy participants approximately 11-13 months of age who previously received a two-dose primary series of Hexyon® (HHV group) or Vaxelis® (VVV group) all received a Vaxelis® booster dose. Immunogenicity was evaluated by measuring antibody levels to individual vaccine antigens approximately 30 days following booster vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). The proportions of participants with antibody-specific responses for antigens contained in both Vaxelis® and Hexyon® at 30 days post-toddler-booster vaccination with Vaxelis® were comparable between groups, and higher in the VVV group for Vaxelis® antigens PRN and FIM2/3. The overall proportions of participants with AEs were generally comparable between groups. Following a booster dose of Vaxelis®, immune responses were comparable between groups for all shared antigens, and higher in the VVV group for antigens found only in Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens.
Asunto(s)
Difteria , Vacunas contra Haemophilus , Haemophilus influenzae tipo b , Tétanos , Tos Ferina , Humanos , Lactante , Virus de la Hepatitis B , Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas Combinadas , Tétanos/prevención & control , Difteria/prevención & control , Tos Ferina/prevención & control , Vacuna Antipolio de Virus Inactivados , Vacunas contra Hepatitis B , Esquemas de Inmunización , Anticuerpos AntibacterianosRESUMEN
OBJECTIVE: To investigate underreporting of immunization errors based on vaccination records from children under five years of age. METHOD: An epidemiological, cross-sectional analytical study, carried out through a household survey with 453 children aged 6 months to 4 years in three municipalities in Minas Gerais in 2021. A descriptive analysis was carried out, and the prevalence of the error was calculated per 100 thousand doses applied between 2016 and 2021. The magnitude was estimated of the association between variables by prevalence and 95% Confidence Intervals (95%CI). To analyze underreporting, State reporting records were used. RESULTS: A prevalence of immunization errors was found to be 41.9/100,000 doses applied (95%CI:32.2 - 51.6). The highest prevalence occurred between 2020 (50.0/100,000 doses applied) and 2021 (78.6/100,000 doses applied). The most frequent error was an inadequate interval between vaccines (47.2%) associated with adsorbed diphtheria, tetanus and pertussis (DTP) vaccine (13.7/100,000) administration. Vaccination delay was related to immunization errors (7.55 95% CI:2.30 - 24.80), and the errors found were underreported. CONCLUSION: The high prevalence of underreported errors points to a worrying scenario, highlighting the importance of preventive measures.