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Molecular evidence suggests the occurrence of Entamoeba moshkovskii in pigs with zoonotic potential from eastern India

Folia Parasitol (Praha). 2022 May 23;69:2022.012. doi: 10.14411/fp.2022.012.

ABSTRACT

Entamoeba moshkovskii Tshalaia, 1941 is prevalent in developing countries and it is considered to be primarily a free-living amoeba, which is morphologically indistinguishable, but biochemically and genetically different from the human infecting, pathogenic Entamoeba histolytica Schaudinn, 1903. The pathogenic potential of this organism is still under discussion. Entamoeba moshkovskii in human stool samples has been reported in different countries such as the United States, Italy, Australia, Iran, Turkey, Bangladesh, India (Pondicherry), Indonesia, Colombia, Malaysia, Tunisia, Tanzania and Brazil, but no data are available about the occurrence of E. moshkovskii in farm animals. This study provides data on the occurrence of E. moshkovskii in pigs in a total of 294 fresh faecal samples collected from five different regions in Kolkata, West Bengal, India. Stool samples were tested by nested PCR using primers targeting SSU rDNA of E. moshkovskii. The amplified PCR products were further confirmed by RFLP technique. Purified nested PCR products were also sequenced and identified via BLAST program run on the NCBI website to confirm species along with their genetic characteristics of the E. moshkovskii isolates. Overall 5.4 % samples were identified as E. moshkovskii positive. Results of this study demonstrate that swine can host E. moshkovskii and should be considered as a potential natural reservoir for E. moshkovskii. However, the occurrence of E. moshkovskii infection in pigs was not statistically associated with their faecal consistency, sex and developmental stage.

PMID:35727049 | DOI:10.14411/fp.2022.012

An evaluation of the notifiable disease surveillance system in Chegutu District, Zimbabwe, 2020: a cross-sectional study

Pan Afr Med J. 2022 Mar 16;41:215. doi: 10.11604/pamj.2022.41.215.33712. eCollection 2022.

ABSTRACT

INTRODUCTION: in 2018-2019 Chegutu District had one notification form Tally 1 (T1) that was completed instead of seven for detected notifiable diseases. Different figures of cholera were reported through weekly rapid disease notification system with 106 patients and Notifiable Diseases Surveillance System (NDSS) with 111 patients, causing data discrepancy. We evaluated the NDSS to determine reasons for underperformance and data discrepancy.

METHODS: we conducted descriptive cross-sectional study using updated centres for disease control and prevention guidelines for surveillance system evaluation. We recruited forty-six health workers. Interviewer-administered questionnaires and checklists were used to collect data on reasons for underperformance, reasons for data discrepancy, knowledge of NDSS, surveillance system attributes and usefulness. Epi InfoTM7 generated frequencies, proportions, and means. Likert scale was used to assess health worker knowledge.

RESULTS: of the forty-six health workers, 34 (78%) had fair knowledge of NDSS. The reason for system underperformance was lack of training in NDSS 42 (91%). Data discrepancy was attributed to typographical mistakes made during data entry on WhatsApp platform 32 (70%). Eighty per cent (37) were willing to complete T1 forms. Six participants who were timed took ten minutes to complete T1 forms. Among 17 health facilities, only three had fifteen T1 forms that were adequate to notify first five cases in an outbreak. Notifiable diseases surveillance system data was used for planning health education 28 (68%).

CONCLUSION: the NDSS was unstable due to health workers' inadequate knowledge and unavailability of T1 forms. Notifiable diseases surveillance system was found to be simple, acceptable, and useful. We recommended NDSS training of health workers.

PMID:35721640 | PMC:PMC9167489 | DOI:10.11604/pamj.2022.41.215.33712

Infectious Disease Control and Management in Ethiopia: A Case Study of Cholera

Front Public Health. 2022 May 30;10:870276. doi: 10.3389/fpubh.2022.870276. eCollection 2022.

ABSTRACT

Cholera remains a significant public health problem among the vulnerable populations living in many resource-limited settings with poor access to safe and clean water and hygiene practice. Around 2.86 million cholera cases and 95,000 deaths are estimated to occur in endemic countries. In Ethiopia, cholera has been one of the major epidemic diseases since 1634 when the first cholera outbreak was recorded in-country. Several cholera epidemics occurred with recent outbreaks in 2019-2021. Cholera has been often reported as acute watery diarrhea due to limited diagnostic capacity in remote areas in Ethiopia and sensitivities around cholera outbreaks. The government of Ethiopia has been executing several phases of multi-year health sector development plan in the past decades and has recently developed a national cholera control plan. Here, we aim to present the existing cholera control guidelines and health system in Ethiopia, including case detection and reporting, outbreak declaration, case management, and transmission control. Challenges and way forward on further research and public health interventions are also discussed to address the knowledge and health service gaps related to cholera control in Ethiopia.

PMID:35712321 | PMC:PMC9197421 | DOI:10.3389/fpubh.2022.870276

Burden and pattern of acute diarrhea in Thai children under 5 years of age: a 5-year descriptive analysis based on Thailand National Health Coverage (NHC) data

BMC Public Health. 2022 Jun 10;22(1):1161. doi: 10.1186/s12889-022-13598-8.

ABSTRACT

BACKGROUND: The incidence of acute diarrhea in Thai children under five years of age has increased over the last three decades. Even though mortality has significantly declined, the burden and cost of medical treatment are still high. Our objectives are to describe the burden and pattern of acute diarrhea cases that required admissions by Thai children under five years of age from 2015 to 2019.

METHODS: Data regarding the admission of acute diarrhea cases of Thai children with Thailand National Health Coverage (NHC) under five years of age from 2015 to 2019, recorded as International Statistical Classification of Diseases and Related Health Problems, tenth Revision, Thai Modification (ICD-10-TM), were analyzed.

RESULTS: The incidence trend of yearly acute diarrhea in children 0-5 years of age slightly increased from 33.36 cases per 1,000 population in 2010 to an average of 33.79 cases per 1,000 population/ year from 2015 to 2019 or approximately 0.43 cases per 1,000 population over the last decade while diarrhea-related mortality had a low, constant rate of 0.71 to 1.16 per 100,000 population per year. Two thirds of the mortality rate was observed in children under 1 year of age or 4.1 cases per 100,000 person-years in 5-year period (P < 0.01). The high cost of performing the medical treatment of approximately four hundred million baht per year. Seasonal variations demonstrated consistency with similar patterns during the cold and rainy seasons throughout the 5-year period. Regional distribution of the causative agent was also observed in Cholera, Typhoid, and Amoebiasis cases. A08: viral and other specified intestinal infections and A09: other gastroenteritis and colitis of infectious and unspecified origin were the two most common causes of diarrheal diseases.

CONCLUSIONS: The incidence rate of acute diarrhea in Thai children under five years of age was higher while the mortality rate of acute diarrhea was lower than those in the past decade. A similar seasonal outbreak of acute diarrhea was seen during each examined year. The causative agent was not significant and was mainly unspecific.

TRIAL REGISTRATION: Number TCTR20220117002, date of registration: 17/01/2022, site: Thai Clinical Trials Registry, URL http://www.thaiclinicaltrials.org/show/TCTR20220117002.

PMID:35689279 | DOI:10.1186/s12889-022-13598-8

Vibrio cholerae: a pathogen shared by human and aquatic animals

Lancet Microbe. 2022 Jun;3(6):e402. doi: 10.1016/S2666-5247(22)00125-2.

NO ABSTRACT

PMID:35659898 | DOI:10.1016/S2666-5247(22)00125-2

Outbreak investigation of acute watery diarrhea in a village of North India: timely action saved lives

J Infect Dev Ctries. 2022 May 30;16(5):843-849. doi: 10.3855/jidc.13113.

ABSTRACT

INTRODUCTION: Outbreaks of acute watery diarrhoea are common in developing countries having poor access to safe drinking water and sanitation. An outbreak of acute watery diarrhoea in a village in North India was investigated with the aim to initiate and recommend necessary actions to control it.

METHODOLOGY: A house to house survey using a specially designed case record form was conducted covering all the households. Stool samples of some of the affected individuals and twenty water samples during and after the outbreak from various sites were collected for laboratory analysis.

RESULTS: Out of 624 inhabitants surveyed, 118 were found to be suffering from acute watery diarrhoea (Overall attack rate of 18.9%) with two suspected deaths following diarrhoea. Males and females were affected equally and the age group of 15-44 years was affected predominantly. A peculiar epidemic curve with single peak was noted. One of the stool samples collected during the outbreak grew Vibrio Cholera O1(Ogawa) and twelve out of the twenty water samples including the samples from both the tube wells had high coliform counts indicating fecal contamination. Chlorine levels in all the water samples were found to be inadequate.

CONCLUSIONS: Local cultural practices such as indiscriminate defecation in public places, using tullu pumps to extract water from the public supply line, poor engineering design and maintenance of the water supply system having leakages at many sites along with inadequate chlorination of the supply water from the tube wells were the risk factors that could have contributed to this outbreak.

PMID:35656956 | DOI:10.3855/jidc.13113

PVBase: A MALDI-TOF MS Database for Fast Identification and Characterization of Potentially Pathogenic <em>Vibrio</em> Species From Multiple Regions of China

Front Microbiol. 2022 May 17;13:872825. doi: 10.3389/fmicb.2022.872825. eCollection 2022.

ABSTRACT

The potentially pathogenic species of the genus Vibrio pose a threat to both humans and animals, creating medical burdens and economic losses to the mariculture industry. Improvements in surveillance and diagnosis are needed to successfully manage vibriosis outbreaks. Matrix assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) can provide rapid diagnosis and has been widely used in the identification of Vibrio spp. The main weakness of this technology is the limited number of strains and species of Vibrio in the existing commercial database. Here, we develop a new in-house database named PVBase containing 790 main spectra projections (MSP) of ten Vibrio species that come from various regions of China and include abundant clinical and environmental strains. PVBase was validated through a blind test of 65 Vibrio strains. The identification accuracy and scoring of Vibrio strains was greatly improved through the addition of PVBase. Identification accuracy increased from 73.4 to 100%. The number of strains with identification scores above 2.2 increased from 53.1% to 96.9% and 53.1% of strains had an identification score above 2.59. Moreover, perfect discrimination was obtained when using all of the MSPs created for the Vibrio species, even for very closely related species such as V. cholerae, V. albensis, and V. mimicus or V. alginolyticus, V. parahaemolyticus, and V. harveyi. In addition, we used phyloproteomic analysis to study whether there are differences in protein fingerprints of different regions or pathogenic strains. We found that MSP characteristics of Vibrio species were not related to their region or source. With the construction of PVBase, the identification efficiency of potentially pathogenic Vibrio species has been greatly improved, which is an important advance for epidemic prevention and control, and aquaculture disease detection.

PMID:35656002 | PMC:PMC9152771 | DOI:10.3389/fmicb.2022.872825

Economic impact of cholera in households in rural southern Malawi: a prospective study

BMJ Open. 2022 Jun 1;12(6):e052337. doi: 10.1136/bmjopen-2021-052337.

ABSTRACT

INTRODUCTION: Cholera remains a significant contributor to diarrhoeal illness, especially in sub-Saharan Africa. Few studies have estimated the cost of illness (COI) of cholera in Malawi, a cholera-endemic country. The present study estimated the COI of cholera in Nsanje, southern Malawi, as part of the Cholera Surveillance in Malawi (CSIMA) programme following a mass cholera vaccination campaign in 2015.

METHODS: Patients ≥12 months of age who were recruited as part of CSIMA were invited to participate in the COI survey. The COI tool captured household components of economic burden, including direct medical and non-medical costs, and indirect lost productivity costs.

RESULTS: Between April 2016 and March 2020, 40 cholera cases were enrolled in the study, all of whom participated in the COI survey. Only two patients had any direct medical costs and five patients reported lost wages due to illness. The COI per patient was US$14.34 (in 2020), more than half of which was from direct non-medical costs from food, water, and transportation to the health centre.

CONCLUSION: For the majority of Malawians who struggle to subsist on less than US$2 a day, the COI of cholera represents a significant cost burden to families. While cholera treatment is provided for free in government-run health centres, additional investments in cholera control and prevention at the community level and financial support beyond direct medical costs may be necessary to alleviate the economic burden of cholera on households in southern Malawi.

PMID:35649608 | DOI:10.1136/bmjopen-2021-052337

HIV epidemic amidst COVID-19 pandemic in India: a conundrum for the country's healthcare system

Epidemiol Infect. 2022 May 26;150:e112. doi: 10.1017/S095026882200098X.

ABSTRACT

India has the third-largest burden of human immunodeficiency virus (HIV) infection in the world. The coronavirus disease 2019 (COVID-19) pandemic has only exposed the cracks in the Indian healthcare infrastructure concerning HIV. The prevalence of HIV in India is more among the destitute or sections of society shrouded by years of social stigma such as prostitutes, truck drivers, transsexuals and intravenous drug users. National AIDS Control Organisation and The Joint United Nations Programme on HIV/AIDS (UNAIDS) organisation have many several efforts over the years to set up counselling and testing centres all over the country and spread awareness about HIV among the masses. COVID-19 pandemic has reversed years of progress made by the same. HIV patients are biologically more susceptible to COVID-19, and the lockdown has led to the loss of jobs, economic crises, shortage of drugs and necessities such as food and housing among this vulnerable population, which can result in lowered CD4-T cell counts in the coming months and make way for dangerous opportunistic infection outbreaks in this population increasing the overall HIV burden of India. This article explores how COVID-19 has impacted India's already existing HIV epidemic and tries to put forth recommendations based on the evidence found to be better prepared in treating the HIV-positive population in India in the face of another catastrophe like the COVID-19.

PMID:35615920 | DOI:10.1017/S095026882200098X

Application of the Child Health and Nutrition Research Initiative (CHNRI) methodology to prioritize research to enable the implementation of Ending Cholera: A global roadmap to 2030

PLoS One. 2022 May 26;17(5):e0264952. doi: 10.1371/journal.pone.0264952. eCollection 2022.

ABSTRACT

BACKGROUND: The "Ending Cholera: A Global Roadmap to 2030" (Roadmap) was launched in October 2017. Following its launch, it became clear that additional evidence is needed to assist countries in controlling cholera and that a prioritized list of research questions is required to focus the limited resources to address the issues most relevant to the implementation of the Roadmap.

METHODS: A comprehensive list of research questions was developed based on inputs from the Working Groups of the Global Taskforce for Cholera Control and other experts. The Child Health and Nutrition Research Initiative methodology was adapted to identify the relevant assessment criteria and assign weights to each criterion. The assessment criteria were applied to each research question by cholera experts to derive a score based on which they were prioritized.

FINDINGS: The consultation process involved 177 experts and stakeholders representing different constituencies and geographies with research priority scores ranging from 88·8 to 65·7% and resulted in the prioritization of the top 20 research questions across all Roadmap pillars, the top five research questions for each Roadmap pillar, and three discovery research questions. This resulted in 32 non-duplicative research questions that considers both immediate and long-term Roadmap goals.

INTERPRETATION: The transparent, inclusive, and rigorous process to develop a Research Agenda is aimed to secure broad buy-in and serve as a guide for funding agencies and researchers to focus their efforts to fill the evidence gaps plaguing cholera-endemic countries.

PMID:35617278 | PMC:PMC9135262 | DOI:10.1371/journal.pone.0264952

Dynamic mapping of cholera outbreak during the Yemeni Civil War, 2016-2019

J Public Health Policy. 2022 May 25. doi: 10.1057/s41271-022-00345-x. Online ahead of print.

ABSTRACT

Widespread destruction from the Yemeni Civil War (2014-present) triggered the world's largest cholera outbreak. We compiled a comprehensive health dataset and created dynamic maps to demonstrate spatiotemporal changes in cholera infections and war conflicts. We aligned and merged daily, weekly, and monthly epidemiological bulletins of confirmed cholera infections and daily conflict events and fatality records to create a dataset of weekly time series for Yemen at the governorate level (subnational regions administered by governors) from 4 January 2016 through 29 December 2019. We demonstrated the use of dynamic mapping for tracing the onset and spread of infection and manmade factors that amplify the outbreak. We report curated data and visualization techniques to further uncover associations between infectious disease outbreaks and risk factors and to better coordinate humanitarian aid and relief efforts during complex emergencies.

PMID:35614203 | DOI:10.1057/s41271-022-00345-x

Outbreak of Imported Seventh Pandemic Vibrio cholerae O1 El Tor, Algeria, 2018

Emerg Infect Dis. 2022 Jun;28(6):1241-1245. doi: 10.3201/eid2806.212451.

ABSTRACT

After a lull of >20 years, Algeria experienced a cholera outbreak in 2018 that included 291 suspected cases. We found that outbreak isolates were Vibrio cholerae O1 serotype Ogawa from seventh pandemic El Tor sublineage AFR14, which corresponds to a new introduction of cholera into Africa from South Asia.

PMID:35608654 | DOI:10.3201/eid2806.212451

Travel vaccines are strongly associated to reduced mortality in prostate cancer patients - a real effect or residual confounding?

Vaccine. 2022 May 21:S0264-410X(22)00611-9. doi: 10.1016/j.vaccine.2022.05.028. Online ahead of print.

ABSTRACT

Repurposing of existing drugs and vaccines for diseases that they were not originally intended for is a promising research field. Recently there has been evidence that oral cholera vaccine might be used in the treatment of inflammatory disease and some common cancers. Specifically, Ji et al showed that the administration of cholera vaccine after a prostate cancer diagnosis reduced prostate cancer specific mortality rates by almost 50%. In a cohort of men from Stockholm, Sweden, with more detailed cancer data and a higher coverage of exposure to vaccine, we replicated these findings using a marginal structural Cox model. We showed that administration of cholera vaccine after prostate cancer diagnosis is associated with a significant reduction in mortality (HR 0.46, 95% CI 0.31-0.69, p-value 0.0001) even after adjusting for all known confounders. However, the same effect (or even stronger) could be seen for several other traveling vaccines and malaria prophylaxis. Therefore, we conclude that this effect is most likely due to a healthy traveler bias and is an example of residual confounding.

PMID:35610103 | DOI:10.1016/j.vaccine.2022.05.028

Inadequate Hand Washing, Lack of Clean Drinking Water and Latrines as Major Determinants of Cholera Outbreak in Somali Region, Ethiopia in 2019

Front Public Health. 2022 May 6;10:845057. doi: 10.3389/fpubh.2022.845057. eCollection 2022.

ABSTRACT

INTRODUCTION: Cholera remains a serious public health problem characterized by a large disease burden, frequent outbreaks, persistent endemicity, and high mortality, particularly in tropical and subtropical low-income countries including Ethiopia. The recent cholera outbreak in the Somali region began on 4 September to 1 November 2019. Cholera may spread rapidly through a population so that an early detection and reporting of the cases is mandatory. This study aimed to identify determinants of cholera infection among >5 years of age population in Somali region, Ethiopia.

METHODS: A community-based unmatched case-control study was conducted among 228 (76 cases and 152 controls, 1:2 ratio) systematically selected population. Data were collected using a structured questionnaire administered by an interviewer and a record review. Descriptive statistics and multivariable logistic regression analysis was used to identify the determinants of the risk factors of cholera infection with a 95% confidence interval and statistical significance was declared a tap-value < 0.05.

RESULTS: A total of 228 participants (33.3% cases and 66.7% controls) were enrolled in this study. The majority of the cases were in the range of 20-49 years of age (69.7%). The odds of acquiring cholera infection increased significantly by drinking unsafe pipe water (AOR 4.3, 95% CI 1.65-11.2), not having a household level toilet/latrine (AOR 3.25, 95% CI 1.57-6.76), hand washing only sometimes after the toilet (AOR 3.04, 95% CI 1.58-5.86) and not using water purification methods (AOR 2.3, 95% CI 1.13-4.54).

CONCLUSION: Major risk factors for cholera infection were related to drinking water and latrine hygiene. Improvement in awareness creation about cholera prevention and control methods, including water treatment, hygiene and sanitation were crucial in combating this cholera outbreak. Primary public health actions are ensuring clean drinking water, delivery of water purification tablets, soap and hand sanitizers and provision of health care and outbreak response. Long term goals in cholera affected areas include comprehensive water and sanitation strategies. Overall, the strategic role of a multi-sectoral approach in the design and implementation of public health interventions aimed at preventing and controlling cholera are essential to avert cholera outbreaks. Preparedness should be highlighted in cholera prone areas like Somali region especially after drought periods.

PMID:35602140 | PMC:PMC9120658 | DOI:10.3389/fpubh.2022.845057

Cholera outbreaks in sub-Saharan Africa during 2010-2019: A Descriptive Analysis

Int J Infect Dis. 2022 May 20:S1201-9712(22)00303-4. doi: 10.1016/j.ijid.2022.05.039. Online ahead of print.

ABSTRACT

BACKGROUND: Cholera remains a public health threat, but is inequitably distributed across sub-Saharan Africa. Lack of standardized reporting and inconsistent outbreak definitions limit our understanding of cholera outbreak epidemiology.

METHODS: From a database of cholera incidence and mortality, we extracted data from sub-Saharan Africa and reconstructed outbreaks of suspected cholera starting in January 2010 to December 2019 based on location-specific average weekly incidence rate thresholds. We then described the distribution of key outbreak metrics.

RESULTS: We identified 999 suspected cholera outbreaks in 744 regions across 25 sub-Saharan Africa countries, and outbreak periods accounted for 1.8 billion person-months (2% of the total during this period) from January 2010 through January 2020. Among 692 outbreaks reported from second-level administrative units (e.g., districts), the median attack rate was 0.8 per 1,000 people (IQR, 0.3-2.4 per 1,000), the median epidemic duration was 13 weeks (IQR, 8-19), and the median early outbreak reproductive number was 1.8 (range, 1.1-3.5). Larger attack rates were associated with longer times to outbreak peak, longer epidemic durations, and lower case fatality risks.

CONCLUSIONS: This work provides a baseline from which to monitor progress towards cholera control and essential statistics to inform outbreak management in sub-Saharan Africa.

PMID:35605949 | DOI:10.1016/j.ijid.2022.05.039

Eliminating cholera in Haiti

Lancet. 2022 May 21;399(10339):1928-1929. doi: 10.1016/S0140-6736(22)00924-2.

NO ABSTRACT

PMID:35598613 | DOI:10.1016/S0140-6736(22)00924-2

Etiological and epidemiological characteristics of <em>Vibrio cholerae</em> in Beijing, 2015-2021

Zhonghua Liu Xing Bing Xue Za Zhi. 2022 May 10;43(5):734-738. doi: 10.3760/cma.j.cn112338-20220123-00064.

ABSTRACT

Objective: To analyze the etiological and epidemiological characteristics of Vibrio cholerae in Beijing during 2015-2021 and provide evidence for the prevention and control of cholera. Methods: The V. cholerae strains isolated in Beijing during 2015-2021 were analyzed by serotyping and virulence genes detection. Pulsed field gel electrophoresis (PFGE) was performed for the molecular typing of the strains. Based on the collected epidemiological and clinical data of cholera cases,the epidemiological characteristics of cholera were analyzed by descriptive epidemiology method. Results: A total of 76 Vibrio cholerae O1 strains were isolated in Beijing during 2015-2021, including 61 strains from human, 10 strains from environment and 5 strains from seafood. The 76 strains consisted of 68 Ogawa strains and 8 Inaba strains. Six Ogawa strains isolated from sporadic cases carried ctxAB. After NotⅠ digestion, 76 strains were divided into 33 PFGE patterns. From 2015 to 2021, a total of 38 cholera epidemics were reported in Beijing, most of them were sporadic ones, accounting for 92.11% (35/38). A total of 45 cases were reported, and the cases occurred during June-September accounted for 97.78% (44/45). Cholera cases occurred in 9 districts of Beijing, and the cases reported in Chaoyang district accounted for 42.22% (19/45) and in Changping district accounted for 31.11% (14/45). The age of the cholera cases ranged from 19 to 63 years. Except for one case with unknown clinical symptoms, 44 cases had diarrhea symptoms with 84.09% (37/44) of the cases reporting diarrhea (3-9 times/day), followed by yellow watery stool (95.45%, 42/44), abdominal pain (68.18%, 30/44), nausea and vomiting (40.91%, 18/44) and fever (36.36%, 16/44). Conclusion: Vibrio cholerae strains isolated in Beijing during 2015-2021 were mainly O1 serotype Ogawa,most of which were non-toxigenic. The PFGE of the strains varied. Cholera epidemics occurred in 9 districts of Beijing, but most were sporadic ones with incidence peak during June-September.

PMID:35589581 | DOI:10.3760/cma.j.cn112338-20220123-00064

Safety and immunogenicity of the Rotavac and Rotasiil rotavirus vaccines administered in an interchangeable dosing schedule among healthy Indian infants: a multicentre, open-label, randomised, controlled, phase 4, non-inferiority trial

Lancet Infect Dis. 2022 May 16:S1473-3099(22)00161-X. doi: 10.1016/S1473-3099(22)00161-X. Online ahead of print.

ABSTRACT

BACKGROUND: Rotavirus is the leading cause of severe dehydrating gastroenteritis among children younger than 5 years in low-income and middle-income countries. Two vaccines-Rotavac and Rotasiil-are used in routine immunisation in India. The safety and immunogenicity of these vaccines administered in a mixed regimen is not documented. We therefore aimed to compare the safety and seroresponse of recipients of a mixed regimen versus a single regimen.

METHODS: We did a multicentre, open-label, randomised, controlled, phase 4, non-inferiority trial at two sites in India. We recruited healthy infants aged 6-8 weeks. Infants with systemic disorders, weight-for-height Z scores of less than minus three SDs, or a history of persistent diarrhoea were excluded. Eligible infants were randomly allocated to six groups in equal numbers to receive either the single vaccine regimen (ie, Rotavac-Rotavac-Rotavac [group 1] or Rotasiil-Rotasiil-Rotasiil [group 2]) or the mixed vaccine regimen (ie, Rotavac-Rotasiil-Rotavac [group 3], Rotasiil-Rotavac-Rotasiil [group 4], Rotavac-Rotasiil-Rotasiil [group 5], or Rotasiil-Rotavac-Rotavac [group 6]). Randomisation was done using an online software by site in blocks of at least 12. The primary outcome was seroresponse to rotavirus vaccine, measured using rotavirus-specific serum IgA antibodies 4 weeks after the third dose. The seroresponse rates were compared between recipients of the four mixed vaccine regimens (consisting of various combinations of Rotavac and Rotasiil) with recipients of the single vaccine regimens (consisting of Rotavac or Rotasiil only for all three doses). The non-inferiority margin was set at 10%. Safety follow-ups were done for the duration of study participation. This trial was registered with the Clinical Trials Registry India, number CTRI/2018/08/015317.

FINDINGS: Between March 25, 2019, and Jan 15, 2020, a total of 1979 eligible infants were randomly assigned to receive a single vaccine regimen (n=659; 329 in group 1 and 330 in group 2) or a mixed vaccine regimen (n=1320; 329 each in groups 3 and 4, and 331 each in groups 5 and 6). All eligible participants received the first dose, 1925 (97·3%) of 1979 received the second dose, and 1894 (95·7%) received all three doses of vaccine. 1852 (93·6%) of 1979 participants completed the follow-up. The immunogenicity analysis consisted of 1839 infants (1238 [67·3%] in the mixed vaccine regimen and 601 [32·7%] in the single vaccine regimen; 13 samples were insufficient in quantity) who completed vaccination and provided post-vaccination sera. The seroresponse rate in the mixed vaccine regimen group (33·5% [95% CI 30·9-36·2]) was non-inferior compared with the single vaccine regimen group (29·6% [26·1-33·4]); the seroresponse rate difference was 3·9% (95% CI -0·7 to 8·3). The proportion of participants with any type of solicited adverse events was 90·9% (95% CI 88·4-93·0) in the single vaccine regimen group and 91·1% (89·5-92·6) in the mixed vaccine regimen group. No vaccine-related serious adverse events or intussusception were reported during the study.

INTERPRETATION: Rotavac and Rotasiil can be safely used in an interchangeable manner for routine immunisation since the seroresponse was non-inferior in the mixed vaccine regimen compared with the single vaccine regimen. These results allow for flexibility in administering the vaccines, helping to overcome vaccine shortages and supply chain issues, and targeting migrant populations easily.

FUNDING: Ministry of Health and Family Welfare, Government of India.

TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

PMID:35588754 | DOI:10.1016/S1473-3099(22)00161-X

Cholera amidst COVID-19 pandemic: African healthcare system in jeopardy

Einstein (Sao Paulo). 2022 May 6;20:eCE6938. doi: 10.31744/einstein_journal/2022CE6938. eCollection 2022.

NO ABSTRACT

PMID:35584449 | PMC:PMC9060645 | DOI:10.31744/einstein_journal/2022CE6938

Expected annual probability of infection: A flood-risk approach to waterborne infectious diseases

Water Res. 2022 Jul 1;219:118561. doi: 10.1016/j.watres.2022.118561. Epub 2022 May 8.

ABSTRACT

This study introduces a new approach for the investigation of infections after an accidental ingestion of contaminated floodwater. The concept of Expected Annual Probability of Infection (EAPI) is introduced and implemented in an infection risk-model approach, by combining a Quantitative Microbial Risk Assessment (QMRA) with the four steps in flood risk assessment. Two groups and exposure paths are considered: adults wading in floodwater and small children swimming/playing in floodwater. The study area is located in Ghana, West Africa. Even though Ghana is one of the most urbanized countries in Africa it has significant problems with water resources management and public health. While cholera is classified as endemic in Accra, the natural and human-made characteristics of the capital makes it prone to flooding. The results of the EAPI approach show that on one hand the concentration of pathogens in floodwater, and thus the risk of infection, decreases with the increase of the flood magnitude. On the other hand, larger floods can spread the pathogens further from the point source, threatening populations previously not identified as at risk by small-scale floods. The concept of EAPI is demonstrated for cholera but it can be extended to other waterborne diseases and also different pathways of exposure, requiring minimal adaptations. For future applications, better estimation of EAPI key components and improvement points are discussed and recommendations given for all the assessment steps.

PMID:35576764 | DOI:10.1016/j.watres.2022.118561

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