RESUMO
Background: Measles is one of the leading causes of under-five mortality and morbidity worldwide. Although the routine service for the second dose of the measles-containing vaccine (MCV2) was introduced in Ethiopia recently, there is a paucity of evidence regarding its coverage and the factors that hinder its uptake at both the local and national levels. Thus, this study aimed to assess the uptake of MCV2 and its associated factors among children aged between 15 and 36 months old in Jigjiga City, Somali Region, Ethiopia. Methods: A community-based cross-sectional study was conducted among 429 children aged between 15 and 36 months old with their mothers/caregivers in Jigjiga City from April 1 to May 1, 2023. A multistage sampling technique was used and data were collected by using structured interviewer-administered questionnaires. The collected data were entered into Epi-data version 3.2 and analyzed in a statistical package for the social sciences (SPSS) version 26. Bivariate and multivariable logistic regression analyses were performed to identify factors associated with the uptake of the measles second dose vaccine. An adjusted odds ratio with 95% CI were reported and statistical significance was declared at p < 0.05. Results: The coverage of MCV2 among children aged between 15 and 36 months was 21.4% (95% CI: 17.7, 25.2). The educational status of the mother (AOR = 3.154; 95% CI: 1.68, 5.93), place of delivery (AOR = 1.90; 95% CI: 1.08, 3.25), postnatal care visits of the mother (AOR = 2.40; 95% CI: 1.37, 4.22), time taken to reach a health facility (AOR = 2.67; 95% CI: 1.28, 5.57), and knowledge about child vaccination (AOR = 2.43; 95% CI: 1.45, 4.08) were factors significantly associated with the uptake of the measles second dose vaccine. Conclusion: The coverage of MCV2 in the study area was low compared to the national immunization targets. Educational status of the mother/caregivers, place of delivery, postnatal care visits of the mother, time to reach a health facility, and knowledge about vaccination of children were significantly associated with measles second dose vaccination. The focus should be given to improving the awareness of mothers on the importance of child vaccination to improve the uptake of measles second dose vaccine and reduce the burden of measles in the region.
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Vacina contra Sarampo , Sarampo , Humanos , Estudos Transversais , Etiópia , Feminino , Masculino , Vacina contra Sarampo/administração & dosagem , Lactente , Sarampo/prevenção & controle , Pré-Escolar , Inquéritos e Questionários , Cobertura Vacinal/estatística & dados numéricos , Adulto , Conhecimentos, Atitudes e Prática em Saúde , Vacinação/estatística & dados numéricosRESUMO
Introduction. At the end of 2019 and the year before, there was a significant spread of measles in the World Health Organization (WHO) European Region.Gap statement. Among the countries that reported, a measles outbreak was Bosnia and Herzegovina (BiH).Aim. To describe the measles outbreak in BiH (an entity of the Federation of BiH, FBiH) in 2019.Methodology. Confirmatory IgM serology, measles nucleic acid detection by real-time RT-PCR and virus genotyping were done in the WHO-accredited laboratory for measles and rubella at the Clinical Center of the University of Sarajevo, Unit for Clinical Microbiology. Genotype was determined in all measles-RNA-positive cases by sequence analysis of the 450 nt fragment coding the C-terminal of measles virus nucleoprotein (N).Results. From 1 January to 31 December 2019, 1332 measles cases were reported, with the peak observed in April 2019 (413/1332, 31.01â%). Sarajevo Canton had the highest incidence, number of cases and percentage (206.4; 868/1332; 65.17â%) of measles cases. Around four-fifths of infected persons were unvaccinated (1086/1332, 81.53â%), while 4.58â% of the patients (61/1332) were immunized with one dose of measles-containing vaccine. The highest proportion of cases was found in children 0-6 years of age (738/1332, 55.41â%). Measles IgM positivity was determined in 75.88â% (346/456), while virus RNA was detected in 82.46â% (47/57) of the swab samples. All measles virus sequences belonged to genotype B3. SNP (position 216: C=>T) was detected in 1 of the 40 sequences obtained during this outbreak.Conclusion. Due to suboptimal immunization coverage, BiH belongs to countries at a high risk for measles outbreaks. Post-COVID-19 (coronavirus disease 2019) pandemic, targeted and tailored strategies are required to ensure routine vaccination demand and acceptance and broad partner and stakeholder group participation.
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COVID-19 , Surtos de Doenças , Genótipo , Vírus do Sarampo , Sarampo , Humanos , Sarampo/epidemiologia , Sarampo/virologia , Sarampo/prevenção & controle , Vírus do Sarampo/genética , Vírus do Sarampo/isolamento & purificação , Vírus do Sarampo/classificação , Vírus do Sarampo/imunologia , Criança , Masculino , Adulto , Pré-Escolar , Adolescente , Feminino , Adulto Jovem , Lactente , COVID-19/epidemiologia , COVID-19/prevenção & controle , Bósnia e Herzegóvina/epidemiologia , Pessoa de Meia-Idade , Imunoglobulina M/sangue , RNA Viral/genética , SARS-CoV-2/genética , SARS-CoV-2/imunologia , SARS-CoV-2/isolamento & purificação , Vacina contra Sarampo/administração & dosagem , Anticorpos Antivirais/sangueRESUMO
BACKGROUND: Each year, vaccine-preventable diseases cost the lives of 8.8 million under-five children. Although vaccination prevents 1-2 million childhood deaths worldwide, measles vaccination dropouts are not well studied in developing countries, particularly in Ethiopia. Therefore, this study aims to assess the spatial distribution of the measles vaccination dropout and its determinants among under-five children in Ethiopia. METHODS: Data from Ethiopian Demographic and Health Survey 2019 was used for data analysis. The study used a total of 5,753 children. Spatial autocorrelations was used to determine the spatial dependency of measles vaccination dropout. Ordinary interpolation was employed to forecast measles vaccination dropout. Factors associated with measles vaccination dropout were declared significant at p-values <0.05. The data were interpreted using the confidence interval and adjusted odds ratio. A model with the lowest deviance and highest logliklihood ratio was selected as the best-fit model. RESULTS: In Ethiopia, one in three under-five children had measles vaccination dropouts. Factors such as birth interval (AOR = 1.87, 95% CI: 1.30, 2.70), unmarried marital status women (AOR = 3.98, 95% CI: 1.08, 8.45), ≤1 number of under-five children (AOR = 3.86, 95% CI: 2.56, 5.81), rural place of residence (AOR = 2.43, 95% CI: 2.29, 3.11), low community-level ANC utilization (AOR = 3.20, 95% CI: 2.53, 3.56), and residing in Benishangul Gumuz (AOR = 1.80, 95% CI: 1.061, 3.06) had higher odds of measles vaccination dropout. CONCLUSIONS: Measles vaccination dropout rates in Ethiopia among under-five children were high compared to the maximum tolerable vaccination dropout level of 10% by the WHO. Both individual and community-level variables were determinants of measles vaccination dropout. The ministry of health in Ethiopia should give attention to those mothers of under-five children who reported underutilization of ANC services and rural residences while designing policies and strategies in areas of high spatial clustering of vaccine dropout in Ethiopia.
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Inquéritos Epidemiológicos , Vacina contra Sarampo , Sarampo , Análise Multinível , Vacinação , Humanos , Etiópia , Feminino , Masculino , Pré-Escolar , Vacina contra Sarampo/administração & dosagem , Vacinação/estatística & dados numéricos , Sarampo/prevenção & controle , Sarampo/epidemiologia , Lactente , Adulto , Análise Espacial , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Adulto Jovem , AdolescenteRESUMO
OBJECTIVES: Measles cases are increasing remarkably in our country as well as all over the world. In this study, it was aimed to examine the epidemiological and clinical characteristics of measles cases detected in our hospital, as well as the measles seroprevalence in our region. METHODS: A total of 7,452 individuals whose measles IgG and/or IgM antibodies were studied between December 2021 and March 2023 in the Medical Virology Laboratory in Basaksehir Çam and Sakura City Hospital were included in this retrospective study. Measles IgG and IgM antibodies were analysed by enzyme-linked immunosorbent assay. Demographic information, clinical symptoms and laboratory data of the participants were obtained from the hospital's electronic medical records. RESULTS: A total of 102 measles cases were identified between December 2021 and March 2023. Of these cases, 77 (75.5%) patients were ≤ 18 years old. Of the 73 measles cases with vaccination information, 90% were unvaccinated. The measles seroprevalence rate was 72.8%. The lowest seroprevalence rate (4.8%) among the age groups was found in 8-11-month-old babies, the highest cases rate (35.7%) was detected in this age group. It was determined that measles immunity increased with age (r = 0.276, p < 0.001) and was over 89.3% over the age of 30. CONCLUSIONS: Measles immunity is insufficient in our region and measles remains an important public health problem until the age of 18. The recent increase in measles cases in our country and around the world shows that current vaccination programmes need to be implemented more decisively and strictly.
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Sarampo , Humanos , Sarampo/epidemiologia , Sarampo/prevenção & controle , Feminino , Masculino , Estudos Retrospectivos , Lactente , Adolescente , Criança , Pré-Escolar , Turquia/epidemiologia , Estudos Soroepidemiológicos , Adulto , Hospitais Urbanos/estatística & dados numéricos , Adulto Jovem , Anticorpos Antivirais/sangue , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Vacina contra Sarampo/administração & dosagemAssuntos
Surtos de Doenças , Programas de Imunização , Vacina contra Sarampo , Sarampo , Humanos , Sarampo/prevenção & controle , Sarampo/epidemiologia , Filipinas/epidemiologia , Feminino , Surtos de Doenças/prevenção & controle , Vacina contra Sarampo/administração & dosagem , Vacinação/estatística & dados numéricosAssuntos
Surtos de Doenças , Programas de Imunização , Vacina contra Sarampo , Sarampo , Humanos , Filipinas/epidemiologia , Sarampo/prevenção & controle , Sarampo/epidemiologia , Feminino , Surtos de Doenças/prevenção & controle , Vacina contra Sarampo/administração & dosagem , Vacinação/estatística & dados numéricos , AdultoAssuntos
Anticorpos Antivirais , Sarampo , Humanos , Feminino , Sarampo/imunologia , Anticorpos Antivirais/imunologia , Anticorpos Antivirais/sangue , Masculino , Vacina contra Sarampo/imunologia , Vacina contra Sarampo/administração & dosagem , Gravidez , Imunidade Materno-Adquirida/imunologia , Fatores Sexuais , Vírus do Sarampo/imunologiaRESUMO
INTRODUCTION: The global measles incidence has decreased from 145 to 49 cases per 1 million population from 2000 to 2018, but evaluating the economic benefits of a second measles-containing vaccine (MCV2) is crucial. This study reviewed the evidence and quality of economic evaluation studies to guide MCV2 introduction. METHODS: The systematic review of model-based economic evaluation studies was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search yielded 2231 articles, with 876 duplicates removed and 1355 articles screened, with nine studies included for final analysis. RESULTS: Six studies reported a positive benefit-cost ratio with one resulting in net savings of $11.6 billion, and two studies estimated a 2-dose MMR vaccination program would save $119.24 to prevent one measles case, and a second dose could prevent 9,200 cases at 18 months, saving $548.19 per case. The most sensitive variables were the discount rate and vaccination administration cost. CONCLUSIONS: Two MCV doses or a second opportunity with an additional dose of MCV were highly cost-beneficial and resulted in substantial cost savings compared to a single routine vaccine. But further research using high-quality model-based health economic evaluation studies of MCV2 should be made available to decision-makers. PROSPERO REGISTRATION: CRD42020200669.
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Análise Custo-Benefício , Programas de Imunização , Vacina contra Sarampo , Sarampo , Humanos , Programas de Imunização/economia , Imunização Secundária/economia , Sarampo/prevenção & controle , Sarampo/economia , Sarampo/epidemiologia , Vacina contra Sarampo/economia , Vacina contra Sarampo/administração & dosagem , Vacina contra Sarampo-Caxumba-Rubéola/administração & dosagem , Vacina contra Sarampo-Caxumba-Rubéola/economia , Vacinação/economia , Vacinação/métodosAssuntos
Anticorpos Antivirais , Recém-Nascido Prematuro , Sarampo , Humanos , Anticorpos Antivirais/sangue , Anticorpos Antivirais/imunologia , Sarampo/imunologia , Sarampo/epidemiologia , Sarampo/prevenção & controle , Recém-Nascido Prematuro/imunologia , Recém-Nascido , Vacina contra Sarampo/imunologia , Vacina contra Sarampo/administração & dosagem , Vírus do Sarampo/imunologia , LactenteRESUMO
Introduction: Measles, though usually self-limiting, can have severe consequences influenced by factors such as vaccination and nutrition, notably vitamin A deficiency and malnutrition. Despite progress, contextual changes and implementation issues have hampered efforts, resulting in increased outbreaks and cases of measles. This study seeks to pinpoint outbreak features, risk factors, and strategies for preventing and controlling measles. Methods: A descriptive cross-sectional study and a 1:2 unmatched case-control study design were employed. All 101 suspected measles cases listed on the line-list were included in the descriptive research, with 60 measles patients and 120 controls included in the case-control investigation. Line-list data were cleaned and analyzed using a pivot table in Microsoft Excel 2016. Subsequently, the data were cleaned, entered into Epi Info 7.2, and exported to SPSS 26 for analysis. Results: Twenty cases occurred per 10,000 individuals. Men accounted for 67.3% of cases, with ages ranging from 5 months to 45 years and mean and standard deviations of 9.6 and 7.6, respectively. Age group of 5-14 years comprised 57.4% of cases, followed by 1-4 years with 24.8%. Being unvaccinated against measles showed an adjusted odds ratio (AOR) of 12.06 (95% CI: 3.12-46.52). Travel history to regions with active cases had an AOR of 5.73 (95% CI: 1.78-18.38). Contact with a measles patient showed an AOR of 10.3 (95% CI: 3.48-30.5). Understanding the measles transmission mechanism had an AOR of 0.164 (95% CI: 0.049-0.55), and awareness of the disease's preventability had an AOR of 0.233 (95% CI: 0.67-0.811). All factors were independently associated with the illness. Conclusion: This outbreak affected a broader age range with a high attack rate, mainly in the age group of 5-14-years. Over 35% of cases lacked measles vaccination, indicating low administrative vaccine coverage. Factors contributing to the outbreak include lack of measles vaccination, travel to areas with active disease, contact with cases, and insufficient knowledge of measles transmission and prevention strategies among mothers and caregivers.
Assuntos
Surtos de Doenças , Sarampo , Humanos , Sarampo/epidemiologia , Sarampo/prevenção & controle , Etiópia/epidemiologia , Surtos de Doenças/estatística & dados numéricos , Masculino , Feminino , Adolescente , Adulto , Estudos Transversais , Criança , Pré-Escolar , Estudos de Casos e Controles , Lactente , Pessoa de Meia-Idade , Fatores de Risco , Adulto Jovem , Vacina contra Sarampo/administração & dosagem , Vacinação/estatística & dados numéricosRESUMO
Background: Measles caused 207,000 deaths worldwide in 2019. Ethiopia ranks among the top 10 countries in the world with the highest number of measles cases. However, the coverage of the second dose of measles-containing vaccine (MCV2) remains low. To increase coverage, the government of Ethiopia launched a nationwide measles vaccination campaign. Despite this intervention, the coverage is still below target, and there is scarce information in the study area. Therefore, this study aimed to assess MCV2 coverage and associated factors among children aged 24-36 months in Gondar city, Central Gondar, Northwest Ethiopia, 2023. Methods: A community-based cross-sectional study was conducted among 621 children aged 24-36 months using a systematic random sampling technique from 25 April to 25 May. A pre-tested, interviewer-administered, and structured questionnaire was used and collected using Kobo Toolbox and then transferred to Stata version 17 for further analysis. The binary logistic regression model was used to identify factors, and the presence of an association was declared using a p-value of <0.05. Similarly, an adjusted odds ratio with a 95% confidence interval was used to interpret the direction and strength of an association. Results: A total of 621 children, with a response rate of 98.1%, participated in the study. The coverage of the second dose of MCV was 75.68% (95% CI: 72.1-78.9). The following factors were significantly associated with measles-containing vaccine second dose (MCV2) coverage: father as the household head (AOR: 3.06, 95% CI: 1.43-6.44), first birth order (AOR: 4.45, 95% CI: 1.21-16.3), four and above antenatal care (ANC) follow-ups (AOR: 5.18, 95% CI:1.62-16.5), postnatal care (PNC) service utilization (AOR: 2.57, 95% CI:1.27-5.15), at least two doses of vitamin A uptake (AOR: 6.39, 95% CI: 2.67-15.2), mothers having high awareness (AOR: 1.97, 95% CI:1.15-3.4), and good perception (AOR: 3.6, 95% CI: 2-6.47) about measles vaccination. Conclusion and recommendations: The coverage of MCV2 in the study area is lower than the national and global target of above 95%. Head of household, birth order, ANC follow-up, PNC service utilization, vitamin A uptake, awareness, and perception of mothers about measles vaccination were significant factors for MCV2 coverage. Creating awareness, increasing the perception of mothers about measles vaccination, and strengthening the ANC and PNC services will increase the coverage.
Assuntos
Vacina contra Sarampo , Sarampo , Cobertura Vacinal , Humanos , Etiópia , Vacina contra Sarampo/administração & dosagem , Estudos Transversais , Feminino , Masculino , Sarampo/prevenção & controle , Pré-Escolar , Cobertura Vacinal/estatística & dados numéricos , Inquéritos e Questionários , Programas de Imunização/estatística & dados numéricos , AdultoRESUMO
Measles is one of the main causes of morbidity and mortality in the pediatric population and it can be prevented with 100% effectiveness by vaccination. However, the disease remains active in throughout Brazil. The scope of this article is to evaluate the population's adherence to vaccination and the potential connection with hospitalizations and mortality in relation to measles in Brazil. This is an ecological study based on secondary data on mortality and hospitalizations due to measles and vaccination coverage against the disease in Brazil from 2013 to 2022. The peak of adherence to the measles vaccination schedule occurred in the 3 years that preceded the eradication of the disease in the country, which occurred in 2016. In this interval, there are the lowest hospitalization rates, with zero mortality from 2014 to 2017. On the other hand, there has been a marked drop in vaccination rates since 2019, when the disease resurfaced in Brazil. Concomitantly, hospitalization and mortality rates reach the highest recorded values. Population adherence to the complete measles vaccination schedule, which is essential to control the disease and related deaths, is insufficient, which is reflected in hospitalization and mortality rates.
O sarampo é uma das principais causas de morbidade e mortalidade na população pediátrica e pode ser prevenido com 100% de eficácia pela vacinação. No entanto, a doença permanece ativa no território brasileiro. O objetivo do artigo é avaliar a adesão da população à vacinação e a possível relação com hospitalização e mortalidade em relação ao sarampo no Brasil. Trata-se de um estudo ecológico realizado a partir de dados secundários de mortalidade e internações acerca do sarampo e da cobertura vacinal contra a doença no Brasil nos anos de 2013 a 2022. O ápice de adesão ao calendário vacinal contra o sarampo se deu nos três anos que precederam a erradicação da doença no país, ocorrida em 2016. Nesse intervalo, tem-se as menores taxas de internação, com a mortalidade zerada de 2014 a 2017. Em contrapartida, verifica-se, desde então, queda na taxas de vacinação, acentuadas a partir de 2019, quando a doença reaparece no Brasil. Concomitantemente, as taxas de internação e mortalidade atingem os valores mais altos registrados. A adesão populacional ao calendário vacinal completo contra o sarampo, essencial ao controle da doença e dos óbitos relacionados, está insuficiente, o que se reflete nas taxas de internações e mortalidade.
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Hospitalização , Programas de Imunização , Vacina contra Sarampo , Sarampo , Cobertura Vacinal , Vacinação , Humanos , Sarampo/prevenção & controle , Sarampo/mortalidade , Sarampo/epidemiologia , Brasil/epidemiologia , Hospitalização/estatística & dados numéricos , Vacina contra Sarampo/administração & dosagem , Cobertura Vacinal/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Esquemas de Imunização , Criança , Pré-Escolar , LactenteRESUMO
Background: Measles continues to be a public health challenge in Ethiopia. Rumors of suspected measles were notified on April 8, 2023 from Tocha district. We conducted an assessment to describe measles outbreak and determine risk factors for measles infection in the Tocha district of the Dawuro zone, Southwest Ethiopia. Methods: We conducted a 1:2 unmatched case-control studies from April to May 2023. We took all 147 cases registered on line list for descriptive analyses. We used a total of 74 randomly selected cases and 147 controls for case-control part. Any person in Tocha district with laboratory-confirmed measles IgM antibody; or any suspected person epidemiologically linked to confirmed measles cases from March 23 to April 26 2023, were included in the case. Neighborhood who did not fulfill this standard case definition were included in controls. Data were collected using standardized questionnaires deployed on Kobo Collect. Descriptive analyses were conducted using Epi info version 7.2.5.0. The analyses were performed using Statistical Package for Social Science (SPSS) version 26. Binary logistic regression analyses were utilized to select candidate variables. We conducted multiple logistic regression analysis to identify determinants of measles infection at a p value ≤0.05 with 95% confidence interval. Results: The overall attack rate of 22.64/10,000 for general population and 104.59/10,000 among under-five children were attributed to the outbreak with a case fatality rate of 2.72%. Vaccine coverage in the last year and this year were 73.52 and 53.88%, respectively, while vaccine effectiveness in the district was 79%. Poor house ventilation (AOR = 3.540, 95% CI: 1.663-7.535) and having contact history with the case (AOR = 2.528, 95% CI: 1.180-4.557) were positively related to measles infection while being previously vaccinated for measles (AOR = 0.209, 95% CI: 0.180-4.577) reduce risk of measles infections. Conclusion: The highest attack rate was observed among children under 5 years of age, with a case fatality rate of 2.72%. Vaccination coverage was less than what expected to develop herd immunity. Strategies to increase vaccination coverage and strengthening surveillance systems for rumor identification and early responses to prevent person to person transmission are recommended.
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Surtos de Doenças , Sarampo , Humanos , Sarampo/epidemiologia , Sarampo/prevenção & controle , Etiópia/epidemiologia , Surtos de Doenças/estatística & dados numéricos , Estudos de Casos e Controles , Masculino , Feminino , Pré-Escolar , Adolescente , Criança , Fatores de Risco , Lactente , Adulto , Adulto Jovem , Vacina contra Sarampo/administração & dosagem , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Measles remains a critical public health concern causing significant morbidity and mortality globally. Despite the success of measles vaccination programs, challenges persist, particularly in India. This study investigates dose-wise measles vaccination coverage and explores gaps in immunization focusing on zero-dose, one-dose, and two-dose coverage among children aged 24-35â¯months. DATA SOURCES AND METHODOLOGY: The National Family Health Survey 2019-21 (NFHS-5) served as the data source and the study analyzed information from 43,864 children aged 24-35â¯months. Sociodemographic variables such as birth order, wealth quintile, gender, social group, religion, residence, mother education, delivery-related factors, and media exposure were considered. Statistical analysis involved weighted estimates, chi-square tests, and multivariate multinomial logistic regression. RESULTS: The study revealed that challenges persist in achieving optimal measles vaccination coverage. Analysis by sociodemographic factors highlighted disparities in coverage, with variations in zero dose prevalence across states and districts. The percentage of zero-dose children was significantly higher, with 11.5% of children in India remaining to receive any measles vaccination. Factors influencing vaccine coverage include birth order, age, wealth quintile, social group, religion, residence, maternal education, place of delivery, media exposure, and mode of delivery. The findings from the spatial analysis show the clustering of zero-dose children is high in the northeastern states of India. DISCUSSION: Measles zero-dose children pose a significant obstacle to achieving elimination goals. Spatial analysis identifies clusters of unvaccinated populations guiding targeted interventions. The study aligns with global initiatives such as the Immunization Agenda 2030 emphasizing equitable vaccine access and discusses how India can tailor its strategies to achieve the goal. Lessons from polio eradication efforts inform strategies for measles elimination, stressing the importance of high-quality data and surveillance. The study underscores the urgency of addressing last-mile measles vaccination gaps in India. Spatially targeted interventions informed by sociodemographic factors can enhance immunization coverage. Achieving measles elimination requires sustained efforts and leveraging lessons from successful vaccination campaigns. The study findings have the potential to contribute to informed decision-making, supporting India's roadmap for the measles and rubella elimination goal.
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Programas de Imunização , Vacina contra Sarampo , Sarampo , Cobertura Vacinal , Humanos , Índia/epidemiologia , Cobertura Vacinal/estatística & dados numéricos , Sarampo/prevenção & controle , Sarampo/epidemiologia , Vacina contra Sarampo/administração & dosagem , Feminino , Masculino , Pré-Escolar , Programas de Imunização/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Erradicação de Doenças/métodos , Erradicação de Doenças/estatística & dados numéricosRESUMO
BACKGROUND: Microneedle patches (MNPs) have been ranked as the highest global priority innovation for overcoming immunisation barriers in low-income and middle-income countries. This trial aimed to provide the first data on the tolerability, safety, and immunogenicity of a measles and rubella vaccine (MRV)-MNP in children. METHODS: This single-centre, phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial was conducted in The Gambia. To be eligible, all participants had to be healthy according to prespecified criteria, aged 18-40 years for the adult cohort, 15-18 months for toddlers, or 9-10 months for infants, and to be available for visits throughout the follow-up period. The three age cohorts were randomly assigned in a 2:1 ratio (adults) or 1:1 ratio (toddlers and infants) to receive either an MRV-MNP (Micron Biomedical, Atlanta, GA, USA) and a placebo (0·9% sodium chloride) subcutaneous injection, or a placebo-MNP and an MRV subcutaneous injection (MRV-SC; Serum Institute of India, Pune, India). Unmasked staff ransomly assigned the participants using an online application, and they prepared visually identical preparations of the MRV-MNP or placebo-MNP and MRV-SC or placebo-SC, but were not involved in collecting endpoint data. Staff administering the study interventions, participants, parents, and study staff assessing trial endpoints were masked to treatment allocation. The safety population consists of all vaccinated participants, and analysis was conducted according to route of MRV administration, irrespective of subsequent protocol deviations. The immunogenicity population consisted of all vaccinated participants who had a baseline and day 42 visit result available, and who had no protocol deviations considered to substantially affect the immunogenicity endpoints. Solicited local and systemic adverse events were collected for 14 days following vaccination. Unsolicited adverse events were collected to day 180. Age de-escalation between cohorts was based on the review of the safety data to day 14 by an independent data monitoring committee. Serum neutralising antibodies to measles and rubella were measured at baseline, day 42, and day 180. Analysis was descriptive and included safety events, seroprotection and seroconversion rates, and geometric mean antibody concentrations. The trial was registered with the Pan African Clinical Trials Registry PACTR202008836432905, and is complete. FINDINGS: Recruitment took place between May 18, 2021, and May 27, 2022. 45 adults, 120 toddlers, and 120 infants were randomly allocated and vaccinated. There were no safety concerns in the first 14 days following vaccination in either adults or toddlers, and age de-escalation proceeded accordingly. In infants, 93% (52/56; 95% CI 83·0-97·2) seroconverted to measles and 100% (58/58; 93·8-100) seroconverted to rubella following MRV-MNP administration, while 90% (52/58; 79·2-95·2) and 100% (59/59; 93·9-100) seroconverted to measles and rubella respectively, following MRV-SC. Induration at the MRV-MNP application site was the most frequent local reaction occurring in 46 (77%) of 60 toddlers and 39 (65%) of 60 infants. Related unsolicited adverse events, most commonly discolouration at the application site, were reported in 35 (58%) of 60 toddlers and 57 (95%) of 60 infants that had received the MRV-MNP. All local reactions were mild. There were no related severe or serious adverse events. INTERPRETATION: The safety and immunogenicity data support the accelerated development of the MRV-MNP. FUNDING: Bill & Melinda Gates Foundation.