RESUMEN
OBJECTIVES: The World Health Organization recommends the use of oral cholera vaccine (OCV) in cholera control efforts. Euvichol®, pre-qualified in 2015, is the leading component of the Global OCV stockpile, but data on its field effectiveness are limited. To evaluate Euvichol® vaccine effectiveness (VE), we conducted a case-control study between September 2018 to March 2020 following an OCV campaign in November 2017 in Haiti. METHODS: Cases were individuals with acute watery diarrhea. Stool samples were tested by culture and real-time polymerase chain reaction of the Vibrio cholerae ctxA gene. Cases were matched to four community controls without diarrhea by residence, enrollment time, age, and gender, and interviewed for sociodemographics, risk factors, and self-reported vaccination. Cholera cases were analyzed by conditional logistic regression in the VE study. Non-cholera diarrhea cases were analyzed in a bias-indicator study. RESULTS: We enrolled 15 cholera cases matched to 60 controls, and 63 non-cholera diarrhea cases matched to 249 controls. In the VE analysis, eight (53%) cases reported vaccination with any number of doses compared to 43 (72%) controls. Adjusted two-dose OCV VE was 69% (95% CI -71 to 94%). CONCLUSIONS: Between 10-27 months after vaccination, Euvichol® was effective and similar to Shanchol™, suggesting that it can serve as one component of multi-sectoral comprehensive cholera control.
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Vacunas contra el Cólera , Cólera , Humanos , Cólera/epidemiología , Cólera/prevención & control , Estudios de Casos y Controles , Haití/epidemiología , Administración Oral , Vacunación , DiarreaAsunto(s)
Vacunas contra el Cólera , Cólera , Humanos , Cólera/epidemiología , Haití , Brotes de EnfermedadesRESUMEN
Oral immunization with the choleric toxin (CT) elicits a high level of protection against its enterotoxin activities and can control cholera in endemic settings. However, the complete B-cell epitope map of the CT that is responsible for protection remains to be clarified. A library of one-hundred, twenty-two 15-mer peptides covering the entire sequence of the three chains of the CT protein (CTP) was prepared by SPOT synthesis. The immunoreactivity of membrane-bound peptides with sera from mice vaccinated with an oral inactivated vaccine (Schankol™) allowed the mapping of continuous B-cell epitopes, topological studies, multi-antigen peptide (MAP) synthesis, and Enzyme-Linked Immunosorbent Assay (ELISA) development. Eighteen IgG epitopes were identified; eight in the CTA, three in the CTB, and seven in the protein P. Three V. cholera specific epitopes, Vc/TxA-3, Vc/TxB-11, and Vc/TxP-16, were synthesized as MAP4 and used to coat ELISA plates in order to screen immunized mouse sera. Sensitivities and specificities of 100% were obtained with the MAP4s of Vc/TxA-3 and Vc/TxB-11. The results revealed a set of peptides whose immunoreactivity reflects the immune response to vaccination. The array of peptide data can be applied to develop improved serological tests in order to detect cholera toxin exposure, as well as next generation vaccines to induce more specific antibodies against the cholera toxin.
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Vacunas contra el Cólera , Cólera , Vibrio cholerae , Animales , Ratones , Vibrio cholerae/metabolismo , Toxina del Cólera/metabolismo , Epítopos de Linfocito B , Mapeo Epitopo , Ensayo de Inmunoadsorción Enzimática , Anticuerpos AntibacterianosAsunto(s)
Vacunas contra el Cólera , Cólera , Humanos , Cólera/epidemiología , Cólera/terapia , Haití , Hospitales , Brotes de Enfermedades , HecesRESUMEN
Diarrheal illness is a major cause of morbidity and mortality among children in Haiti, and the impact of diarrheal illness was compounded by a cholera outbreak between 2010 and 2019. Our understanding of risk factors for diarrhea among children during this outbreak is limited. We conducted a secondary analysis of data collected as part of a cholera vaccine effectiveness study to identify factors associated with medically attended diarrhea among children in central Haiti from October of 2012 through November of 2016. We identified 47 children aged one to five years old who presented to medical clinics with acute, watery diarrhea, and 166 matched controls who did not have diarrhea, and we performed conditional logistic regression to identify factors associated with diarrhea. Discontinuing exclusive breastfeeding within one month of birth was associated with increased risk of diarrhea (RR 6.9, 95% CI 1.46-32.64), and diarrhea was inversely associated with reported history of supplementation with vitamin A (RR 0.05, 95% CI 0.004-0.56) and zinc (reported among 0% of cases vs. 17% of controls). Because of the concordance in supplementation patterns, it was not possible to attribute the association to vitamin A or zinc independently. While having a respondent who correctly identified ≥3 means of avoiding cholera was associated with reduced risk of diarrhea (RR 0.43, 95% CI 0.19-1.01), reported household sanitation practices and knowledge of cholera were not consistently associated with risk of diarrhea. These findings support ongoing efforts to reduce barriers to breastfeeding and promote pediatric supplementation with vitamin A and zinc in Haiti. Given the reduced efficacy of current oral cholera vaccines (OCV) among children, the results reinforce the importance of breastfeeding and micronutrient supplementation in preventing all-cause pediatric diarrheal illness generally and during cholera outbreaks.
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Vacunas contra el Cólera/administración & dosificación , Cólera/prevención & control , Diarrea/prevención & control , Estudios de Casos y Controles , Preescolar , Cólera/epidemiología , Cólera/microbiología , Diarrea/epidemiología , Diarrea/microbiología , Epidemias , Femenino , Haití/epidemiología , Humanos , Lactante , Masculino , Población Rural/estadística & datos numéricos , Eficacia de las Vacunas , Vibrio cholerae/genética , Vibrio cholerae/inmunologíaRESUMEN
Vaccination is a well-established means for prevention and spread of disease in people traveling abroad. Although vaccines to diseases such as cholera are recommended by world health agencies, they are seldom required even when traveling to endemic regions. Consequences of noncompliance can affect traveler's health and spread diseases to new regions, as occurred in Haiti in 2010 when United Nations peacekeepers from Nepal, where a cholera outbreak was underway, introduced the disease to the region. Steps to increase vaccine recommendation compliance should therefore be an integral part of vaccine development. PXVX0200 contains Center for Vaccine Development 103-HgR live, attenuated recombinant Vibrio cholerae vaccine strain, and is indicated for single-dose immunization against the bacteria that causes cholera. It is supplied as one buffer and one active component packet to be mixed into water and ingested. Administration instructions are designed to be "user friendly" with flexibility for self-administration, thus promoting compliance. Studies to support self-administration were conducted to cover stability of the vaccine outside of normal storage conditions, potency in case of misadministration, and disposal procedures to minimize environmental impact. The principal findings showed that the stability of vaccine was maintained under conditions allowing for transport times and temperature conditions as well as when misadministration errors were made. Finally, the vaccine was effectively neutralized with hot water and soap to prevent bacterial environmental contamination in the event of an accidental spill. The conclusion is that PXVX0200 oral vaccine is stable, easy to formulate and dispose of, and is amenable to self-administration.
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Vacunas contra el Cólera/administración & dosificación , Cólera/prevención & control , Vacunación/métodos , Potencia de la Vacuna , Vibrio cholerae/inmunología , Administración Oral , Anticuerpos Antibacterianos/sangre , Haití , Servicios de Atención de Salud a Domicilio , Humanos , Nepal , TemperaturaRESUMEN
Cholera is endemic in over 50 countries with an estimated mortality of 100,000-120,000. Vaccination is considered the complementary key to prevent and control cholera; therefore, alternative vaccine preparations are needed. Toxin Co-regulated Pilus is part of the toxR virulence regulon, which is necessary for colonization in the intestinal mucosa. In order to express Vibrio cholerae TcpA protein in Saccharomyces boulardii, the expression plasmid pYES2 was constructed by inserting tcpA gene isolated from local Vibrio cholerae Eltor Inaba isolates. The new construct was transferred into Saccharomyces boulardii cells and the expression of tcpA gene was induced from the GAL1 promoter by adding galactose to the medium. The SDS-PAGE and Western blot analysis showed the presence of TcpA in yeast. These results showed that Saccharomyces boulardii is a promising host to express Vibrio cholerae toxin TcpA as the first step in attempt to produce an oral Vibrio cholerae vaccine(AU)
El cólera es endémico en más de 50 países. Se estima una mortalidad entre 100.000 - 120.000 debido a esta enfermedad. La vacunación se considera una medida complementaria para prevenir y controlar el cólera, por lo tanto, se necesitan preparaciones vacunales alternativas a las existentes. El Pili corregulado con la toxina, es parte del regulón de virulencia toxR, y es necesario para la colonización en la mucosa intestinal. Para expresar la proteína tcpA de Vibrio cholerae en Saccharomyces boulardii, se construyó el plásmido de expresión pYES2 insertando el gen tcpA obtenido a partir de aislamientos locales de Vibrio cholerae El Tor Inaba. La nueva construcción se transfirió a las células de Saccharomyces boulardii y se indujo la expresión del gen tcpA a partir del promotor GAL1 mediante la adición de galactosa al medio. El análisis mediante SDS-PAGE y Western blot demostró la presencia de TcpA en levaduras. Los resultados demostraron que Saccharomyces boulardii es un hospedero prometedor para expresar el gen tcpA de Vibrio cholerae como el primer paso en el intento de producir una vacuna oral contra Vibrio cholerae(AU)
Asunto(s)
Humanos , Masculino , Femenino , Vacunas contra el Cólera/uso terapéutico , Cólera/mortalidad , Cólera/prevención & control , Infecciones por Escherichia coli , Saccharomyces boulardii/efectos de los fármacosRESUMEN
BACKGROUND: Cholera was introduced into Haiti in 2010. Since then, more than 820â000 cases and nearly 10â000 deaths have been reported. Oral cholera vaccine (OCV) is safe and effective, but has not been seen as a primary tool for cholera elimination due to a limited period of protection and constrained supplies. Regionally, epidemic cholera is contained to the island of Hispaniola, and the lowest numbers of cases since the epidemic began were reported in 2019. Hence, Haiti may represent a unique opportunity to eliminate cholera with OCV. METHODS: In this modelling study, we assessed the probability of elimination, time to elimination, and percentage of cases averted with OCV campaign scenarios in Haiti through simulations from four modelling teams. For a 10-year period from January 19, 2019, to Jan 13, 2029, we compared a no vaccination scenario with five OCV campaign scenarios that differed in geographical scope, coverage, and rollout duration. Teams used weekly department-level reports of suspected cholera cases from the Haiti Ministry of Public Health and Population to calibrate the models and used common vaccine-related assumptions, but other model features were determined independently. FINDINGS: Among campaigns with the same vaccination coverage (70% fully vaccinated), the median probability of elimination after 5 years was 0-18% for no vaccination, 0-33% for 2-year campaigns focused in the two departments with the highest historical incidence, 0-72% for three-department campaigns, and 35-100% for nationwide campaigns. Two-department campaigns averted a median of 12-58% of infections, three-department campaigns averted 29-80% of infections, and national campaigns averted 58-95% of infections. Extending the national campaign to a 5-year rollout (compared to a 2-year rollout), reduced the probability of elimination to 0-95% and the proportion of cases averted to 37-86%. INTERPRETATION: Models suggest that the probability of achieving zero transmission of Vibrio cholerae in Haiti with current methods of control is low, and that bolder action is needed to promote elimination of cholera from the region. Large-scale cholera vaccination campaigns in Haiti would offer the opportunity to synchronise nationwide immunity, providing near-term population protection while improvements to water and sanitation promote long-term cholera elimination. FUNDING: Bill & Melinda Gates Foundation, Global Good Fund, Institute for Disease Modeling, Swiss National Science Foundation, and US National Institutes of Health.
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Vacunas contra el Cólera/administración & dosificación , Cólera/prevención & control , Erradicación de la Enfermedad/métodos , Programas de Inmunización , Administración Oral , Cólera/epidemiología , Haití/epidemiología , Humanos , Incidencia , Modelos Biológicos , Vacunación/estadística & datos numéricosRESUMEN
Oral cholera vaccine (OCV) has increasingly been used as an outbreak control measure, but vaccine shortages limit its application. A two-dose OCV campaign targeting residents aged over 1 year was launched in three rural Communes of Southern Haiti during an outbreak following Hurricane Matthew in October 2016. Door-to-door and fixed-site strategies were employed and mobile teams delivered vaccines to hard-to-reach communities. This was the first campaign to use the recently pre-qualified OCV, Euvichol. The study objective was to estimate post-campaign vaccination coverage in order to evaluate the campaign and guide future outbreak control strategies. We conducted a cluster survey with sampling based on random GPS points. We identified clusters of five households and included all members eligible for vaccination. Local residents collected data through face-to-face interviews. Coverage was estimated, accounting for the clustered sampling, and 95% confidence intervals calculated. 435 clusters, 2,100 households and 9,086 people were included (99% response rate). Across the three communes respectively, coverage by recall was: 80.7% (95% CI:76.8-84.1), 82.6% (78.1-86.4), and 82.3% (79.0-85.2) for two doses and 94.2% (90.8-96.4), 91.8% (87-94.9), and 93.8% (90.8-95.9) for at least one dose. Coverage varied by less than 9% across age groups and was similar among males and females. Participants obtained vaccines from door-to-door vaccinators (53%) and fixed sites (47%). Most participants heard about the campaign through community 'criers' (58%). Despite hard-to-reach communities, high coverage was achieved in all areas through combining different vaccine delivery strategies and extensive community mobilisation. Emergency OCV campaigns are a viable option for outbreak control and where possible multiple strategies should be used in combination. Euvichol will help alleviate the OCV shortage but effectiveness studies in outbreaks should be done.
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Vacunas contra el Cólera/administración & dosificación , Cólera/prevención & control , Vacunación Masiva/métodos , Cobertura de Vacunación , Adolescente , Adulto , Niño , Preescolar , Cólera/epidemiología , Vacunas contra el Cólera/provisión & distribución , Análisis por Conglomerados , Recolección de Datos , Brotes de Enfermedades , Composición Familiar , Femenino , Haití/epidemiología , Humanos , Lactante , Masculino , Población RuralRESUMEN
Social mobilization is an important component of the delivery of vaccines and has to be carried out at different levels. It plays a very critical role in success of a campaign, as was shown by the Polio eradication program in India that was supported by SMNet, a platform created for the purpose. Learnings from this has been used for other vaccine deployments in India as well. In addition, there is a social mobilization effort for routine immunization. A guideline for social mobilization was created by UNICEF specifically for cholera vaccine use during Haiti epidemic in 2010. Since there is a need to develop a roadmap for cholera control in India, especially in the known hotspots, and after natural disasters, we suggest a possible strategy that could be built on the existing framework available in India.
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Vacunas contra el Cólera/administración & dosificación , Cólera , Programas de Inmunización/organización & administración , Cólera/epidemiología , Cólera/prevención & control , Haití , Humanos , India/epidemiologíaRESUMEN
INTRODUCTION: In 2014, an oral cholera vaccine (OCV) campaign targeting 185,314 persons aged ≥1â¯years was conducted in 3 departments via fixed post and door-to-door strategies. This was the first use of the global OCV stockpile in Haiti. METHODS: We conducted a multi-stage cluster survey to assess departmental OCV coverage. Target population estimates were projected from the 2003 Haiti population census with adjustments for population growth and estimated proportion of pregnant women. In the three departments, we sampled 30/106 enumeration areas (EAs) in Artibonite, 30/244 EAs in Centre, and 20/29 EAs in Ouest; 20 households were systematically sampled in each EA. Household and individual interviews using a standard questionnaire were conducted in each selected household; data on OCV receipt were obtained from vaccination card or verbal report. We calculated OCV campaign coverage estimates and 95% confidence intervals (CIs) accounting for survey design. RESULTS: Overall two-dose OCV coverage was 70% (95% CI: 60, 79), 63% (95% CI: 55, 71), and 44% (95% CI: 35, 53) in Artibonite, Centre, and Ouest, respectively. Two-dose coverage was higher in the 1-4â¯years age group than among thoseâ¯≥â¯15â¯years in Artibonite (difference: 11%; 95% CI: 5%, 17%) and Ouest (difference: 12%; 95% CI: 3, 20). A higher percentage of children aged 5-14â¯years received both recommended doses than did thoseâ¯≥â¯15â¯years (Artibonite: 14% (95% CI: 8%, 19%) difference; Centre: 11% difference (95% CI: 5%, 17%); Ouest: 10% difference (95% CI: 2%, 17%). The most common reason for not receiving any OCV dose was being absent during the campaign or not having heard about vaccination activities. CONCLUSIONS: While coverage estimates in Artibonite and Centre were comparable with other OCV campaigns in Haiti and elsewhere, inadequate social mobilization and outdated population estimates might have contributed to lower coverage in Ouest.
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Vacunas contra el Cólera/administración & dosificación , Vacunas contra el Cólera/provisión & distribución , Cólera/prevención & control , Vacunación Masiva/estadística & datos numéricos , Cobertura de Vacunación/estadística & datos numéricos , Administración Oral , Adolescente , Niño , Preescolar , Brotes de Enfermedades/prevención & control , Esquema de Medicación , Composición Familiar , Femenino , Haití , Humanos , Lactante , Masculino , Investigación Cualitativa , Población Rural , Reserva Estratégica/estadística & datos numéricosRESUMEN
Cholera is a common infectious disease caused by Vibrio cholerae, which has different infectivity. In this paper, we propose a cholera model with hyperinfectious and hypoinfectious vibrios, in which both human-to-human and environment-to-human transmissions are considered. By analyzing the characteristic equations, the local stability of disease-free and endemic equilibria is established. By using Lyapunov functionals and LaSalle's invariance principle, it is verified that the global threshold dynamics of the model can be completely determined by the basic reproduction number. Numerical simulations are carried out to illustrate the corresponding theoretical results and describe the cholera outbreak in Haiti. The study of optimal control helps us seek cost-effective solutions of time-dependent control strategies against cholera outbreaks, which shows that control strategies, such as vaccination and sanitation, should be taken at the very beginning of the outbreak and become less necessary after a certain period.
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Cólera/transmisión , Modelos Biológicos , Vibrio cholerae/patogenicidad , Número Básico de Reproducción/estadística & datos numéricos , Cólera/epidemiología , Cólera/microbiología , Vacunas contra el Cólera/farmacología , Simulación por Computador , Análisis Costo-Beneficio , Brotes de Enfermedades/estadística & datos numéricos , Haití/epidemiología , Humanos , Control de Infecciones/economía , Control de Infecciones/métodos , Conceptos Matemáticos , VirulenciaRESUMEN
The bivalent killed whole-cell oral cholera vaccine (BivWC) is being increasingly used to prevent cholera. The presence of O-antigen-specific memory B cells (MBC) has been associated with protective immunity against cholera, yet MBC responses have not been evaluated after BivWC vaccination. To address this knowledge gap, we measured V. cholerae O1-antigen MBC responses following BivWC vaccination. Adults in St. Marc, Haiti, received 2 doses of the BivWC vaccine, Shanchol, two weeks apart. Participants were invited to return at days 7, 21, 44, 90, 180 and 360 after the initial vaccination. Serum antibody and MBC responses were assessed at each time-point before and following vaccination. We observed that vaccination with BivWC resulted in significant O-antigen specific MBC responses to both Ogawa and Inaba serotypes that were detected by day 21 and remained significantly elevated over baseline for up to 12 months following vaccination. The BivWC oral cholera vaccine induces durable MBC responses to the V. cholerae O1-antigen. This suggests that long-term protection observed following vaccination with BivWC could be mediated or maintained by MBC responses.
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Linfocitos B/inmunología , Vacunas contra el Cólera/administración & dosificación , Vacunas contra el Cólera/inmunología , Cólera/prevención & control , Antígenos O/inmunología , Vacunación/métodos , Vibrio cholerae/inmunología , Adulto , Anticuerpos Antibacterianos/sangre , Anticuerpos Antibacterianos/inmunología , Femenino , Haití , Humanos , Memoria Inmunológica , Masculino , Antígenos O/sangre , Factores de Tiempo , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/inmunologíaRESUMEN
BACKGROUND: No study of long-term protection following killed oral cholera vaccination has been done outside of the historically cholera-endemic areas of south Asia, or has examined protection after a single-dose vaccination regimen. To address this, we examined the duration of protection of the standard two-dose regimen and an incomplete regimen of one dose up to 4 years after vaccination in Haiti. METHODS: In the setting of two-dose vaccination campaigns with a killed, bivalent, whole-cell oral cholera vaccination, we did a case-control study from October, 2012 through November, 2016. Eligible participants were required to be resident in the vaccine catchment area (Artibonite Department or Central Department) where they were recruited at the start of the study; and be eligible for the vaccination campaign (ie, aged ≥12 months, not pregnant, and living in the region at the time of the vaccine campaign). Patients with cholera had a positive stool culture and were recruited from cholera treatment centres. Community controls were matched to people with cholera by age group, time, and neighbourhood. We did adjusted matched regression analyses to calculate vaccine effectiveness and examine heterogeneity in effectiveness over time. The primary outcome was the effectiveness of one and two oral cholera doses as compared with zero doses from 2 months to 48 months after vaccination, measured by self reporting. FINDINGS: Among 178 people assigned to the case group and 706 people assigned to the control group, we found no evidence that two-dose effectiveness decreased during follow-up. In adjusted analyses, the average cumulative 4 year effectiveness for two doses was 76% (95% CI 59-86). In contrast, single-dose effectiveness decreased over time in a log-linear fashion, with a predicted vaccine effectiveness of 79% at the end of 12 months (95% CI 43-93), which declined to zero before the end of the second year. INTERPRETATION: In a setting of epidemic and newly endemic cholera in Haiti, single-dose vaccination with killed, bivalent, whole-cell oral cholera vaccination provided short-term protection; however, vaccination with two doses was required for long-term protection, which lasted up to 4 years after vaccination. These results add to the evidence in support of the use of killed, bivalent, whole-cell oral cholera vaccination as part of comprehensive cholera control plans. FUNDING: US National Institute of Allergy and Infectious Diseases of the National Institutes of Health and the Bill & Melinda Gates Foundation.
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Vacunas contra el Cólera/administración & dosificación , Cólera/prevención & control , Vacunación/métodos , Administración Oral , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Casos y Controles , Niño , Preescolar , Cólera/epidemiología , Femenino , Haití/epidemiología , Humanos , Programas de Inmunización , Inmunización Secundaria , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Vacunas de Productos Inactivados/administración & dosificación , Adulto JovenAsunto(s)
Comités Consultivos/organización & administración , Cólera/prevención & control , Brotes de Enfermedades/prevención & control , Programas de Inmunización/organización & administración , Meningitis Meningocócica/prevención & control , Vacunas/provisión & distribución , Fiebre Amarilla/prevención & control , África/epidemiología , Bangladesh/epidemiología , Brasil/epidemiología , Cólera/epidemiología , Vacunas contra el Cólera/provisión & distribución , Urgencias Médicas , Humanos , Meningitis Meningocócica/epidemiología , Vacunas Meningococicas/provisión & distribución , Filipinas/epidemiología , Naciones Unidas , Fiebre Amarilla/epidemiología , Vacuna contra la Fiebre Amarilla/provisión & distribuciónRESUMEN
In October 2010, the Haitian Ministry of Public Health and Population (MSPP; Port au Prince, Haiti) reported a cholera epidemic caused by contamination of the Artibonite River by a United Nation Stabilization Mission camp. Interventional studies of the subsequent responses, including a descriptive Methods section and systematic approach, may be useful in facilitating comparisons and applying lessons learned to future outbreaks. The purpose of this study was to examine publicly available documents relating to the 2010 cholera outbreak to answer: (1) What information is publicly available on interventional studies conducted during the epidemic, and what was/were the impact(s)? and (2) Can the interventions be compared, and what lessons can be learned from their comparison? A PubMed (National Center for Biotechnology Information, National Institutes of Health; Bethesda, Maryland USA) search was conducted using the parameters "Haiti" and "cholera." Studies were categorized as "interventional research," "epidemiological research," or "other." A distinction was made between studies and narrative reports. The PubMed search yielded 171 papers, 59 (34.0%) of which were epidemiological and 12 (7.0%) were interventional studies. The remaining 100 papers (59.0%) comprised largely of narrative, anecdotal descriptions. An expanded examination of publications by the World Health Organization (WHO; Geneva, Switzerland), the Center for Research in the Epidemiology of Disasters (CRED; Brussels, Belgium), United States Agency for International Development (USAID; Washington, DC USA)-Development Experience Clearinghouse (DEC), and US National Library of Medicine's (NLM; Bethesda, Maryland USA) Disaster Literature databases yielded no additional interventional studies. The unstructured formats and differing levels of detail prohibited comparisons between interventions, even between those with a similar approach. Only two (17.0%) interventional studies included any impact data, although neither commented whether the intervention improved health or reduced incidence or mortality related to cholera. Agreed frameworks for guiding responses and subsequent reporting are needed to ensure reports contain sufficient detail to draw conclusions for the definition of best practices and for the design of future interventions. Miller J , Birnbaum ML . Characterization of interventional studies of the cholera epidemic in Haiti. Prehosp Disaster Med. 2018;33(2):176-181.
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Cólera/epidemiología , Brotes de Enfermedades , Terremotos , Cólera/etiología , Cólera/prevención & control , Vacunas contra el Cólera/provisión & distribución , Haití/epidemiología , Humanos , Sistemas de Socorro , SaneamientoRESUMEN
The Dominican Republic, historically non-endemic for cholera, is experiencing an ongoing cholera epidemic. We assessed the safety and immunogenicity of two doses of the killed bivalent (O1 and O139) whole-cell oral cholera vaccine (OCV) on day (D)0 and D14 in healthy participants aged ≥1 year. Immediate unsolicited systemic adverse events (AEs) were monitored up to 30 minutes and solicited systemic reactions, up to 7 days after each vaccination. Unsolicited AEs were recorded up to D14 (post-dose 1) and 30 days post-dose 2. A vibriocidal antibody assay with microtiter technique was used to measure serum antibodies to V. cholerae strains (O1 El Tor Inaba, O1 El Tor Ogawa, O139) on D0, D14 and D28. Geometric mean titers (GMTs) and seroconversion (≥4-fold increase from D0) rates were calculated. We recruited 336 participants; 112 in three age groups (1-4, 5-14 and ≥15 years). No safety concerns were observed. GMTs increased from baseline for all serotypes, with marked increases for O1 Inaba and Ogawa post-dose 1. Post-dose 2 GMTs tended to be equal or slightly lower, with ranges: O1 Inaba, 283 (95% confidence interval 191-419) to 612 (426-880); O1 Ogawa, 346 (223-536) to 754 (553-1028); and O139, 20.3 (13.5-30.6) to 43.8 (30.1-63.7). Seroconversion rates post-dose 2 for O1 Inaba and Ogawa were high (≥87%) for all age groups. OCV demonstrated an acceptable safety profile and robust immunogenicity in these participants, in-line with previous observations in epidemic and endemic settings.This study is registered on www.clinicaltrials.gov (NCT02434822).