Assessment of Smear Layer Removal and Penetration Depth of Root Canal Irrigant Using Different Irrigation Activation Systems: A Comparative Study.

AIM: The aim of the current study was to evaluate the penetration depth and smear layer removal of root canal irrigant using various irrigation activation techniques. MATERIALS AND METHODS: In this investigation, sixty single-rooted premolars extracted for orthodontic purposes were chosen. Diamond burs were used to create an access cavity, and #10 K-file was used to determine the patency. About sixty samples were divided into the following three groups (20 samples in each group), group I: Irrigation with conventional needle, group II: Activation of EndoVac system, group III: Passive ultrasonic irrigation (PUI). The efficacy of the smear layer was assessed using a scanning electron microscopy at a ×2000 magnification. One-way ANOVA was used to record and analyze the data. All statistical analyses were performed with a significance level of p < 0.05. RESULTS: At coronal third, the maximum smear layer was removed in group II (1.26 ± 0.02) followed by group III (1.84 ± 0.16) and group I (2.89 ± 0.21). At middle third, smear layer removal was maximum in group I (1.18 ± 0.10) followed by group III (1.72 ± 0.09) and group I (2.66 ± 0.18). At apical third, the more smear layer was removed in group II (1.02 ± 0.01) followed by group III (1.58 ± 0.08) and group I (2.38 ± 0.06). There was a highly significant difference found between the three different irrigation systems at all three levels (p < 0.001). CONCLUSION: In conclusion, every irrigation device that was evaluated was successful in removing the smear layer from the root canal. However, the EndoVac system group removed a greater amount of smear layer compared with PUI and conventional needle group. CLINICAL SIGNIFICANCE: With the goal of promoting cleaning that is beyond the ability of mechanical devices, irrigation is a crucial part of root canal therapy. If an efficient irrigation delivery system is used, the irrigants can reach the working length (WL). This type of distribution system needs to provide a suitable amount of irrigants up to the WL, as well as have enough flow and be effective at debriding the entire canal system. How to cite this article: Pujari MD, Das M, Das A, et al. Assessment of Smear Layer Removal and Penetration Depth of Root Canal Irrigant Using Different Irrigation Activation Systems: A Comparative Study. J Contemp Dent Pract 2024;25(4):331-334.

Intussusception after Rotavirus Vaccine Introduction in India.

BACKGROUND: A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).

Health occupations salary outcomes: intersections of student race, gender, and first-generation status.

Greater diversity in the healthcare workforce has been identified as a critical need in serving an increasingly diverse population. Higher education institutions have been tasked with increasing the number of underrepresented students in the health occupations pipeline to better align with the demographics of the general population and meet the need for a diverse health occupations workforce. This study used the National Science Foundation's National Survey of College Graduates dataset to capture data across time, examining the intersectionality of race, gender, and first-generation status on the salary outcomes of students who earn degrees related to health occupations. Results indicate that the intersecting identities of students who earn a bachelor's degree or higher in the health professions impact salary outcomes. Results of this study have implications for higher education policies that can impact increased diversity in the health occupations workforce pipeline.

Metabolic syndrome in people living with antiretroviral therapy: A cross-sectional investigation from Pune, India.

Background: Improved longevity of people living with HIV on highly active antiretroviral therapy and accelerated aging processes are considered contributory to Metabolic Syndrome. Objectives: The current study investigated metabolic syndrome (MetS) in people living with HIV (PLH) who were receiving antiretroviral therapy (ART) under the ongoing National AIDS Control Program. Methods: Clinic attendees (n = 3088) who were on ART for more than 6 months constituted the sampling frame, from which 378 study participants were randomly drawn and included in the analysis following the eligibility check. One hundred and fifty-nine clinic attendees, initiated on ART in ≤6 months, provided an opportunity to estimate the prevalence of MetS in them. Sixty-two PLH from this smaller group were enrolled. Results: MetS was found among 19% (73/378; 95% confidence interval [CI] 15.5%-23.7%) PLH who were on ART >6 months compared with 24% (15/62; 95% CI 14.2%-36.7%) in those who were on ART for ≤6 months based on harmonization criteria for the Asian population; the confidence intervals overlapped and apparently observed difference was not statistically significant. Adjusted for age, body mass index (BMI), protease inhibitor (PI)-based ART regimen, duration of ART, insulin resistance (IR), reported family history of hypertension and residential setting, factors independently associated with MetS were PI containing ART regimen, IR, duration of ART intake and BMI. In the adjusted model, the odds of MetS were three times higher among PLH on PI containing ART regimen (95% CI of adjusted odds ratio; aOR 1.27-8.51) and those having IR (95% CI of aOR 1.48-5.07). The odds of MetS among PLH with BMI ≥23 kg/m2 was 4 (95% CI of aOR 2.08-6.81) times higher than those with lower BMI. Conclusions: MetS in PLH requires the attention of health-care workers in India. Appropriate screening would help initiate early management.

Maximizing the Impact of Voluntary Medical Male Circumcision for HIV Prevention in Zambia by Targeting High-Risk Men: A Pre/Post Program Evaluation.

A well-documented barrier to voluntary medical male circumcision (VMMC) is financial loss due to the missed opportunity to work while undergoing and recovering from VMMC. We implemented a 2-phased outcome evaluation to explore how enhanced demand creation and financial compensation equivalent to 3 days of missed work influence uptake of VMMC among men at high risk of HIV exposure in Zambia. In Phase 1, we implemented human-centered design-informed interpersonal communication. In Phase 2, financial compensation of ZMW 200 (~ US$17) was added. The proportion of men undergoing circumcision was significantly higher in Phase 2 compared to Phase 1 (38% vs 3%). The cost of demand creation and compensation per client circumcised was $151.54 in Phase 1 and $34.93 in Phase 2. Financial compensation is a cost-effective strategy for increasing VMMC uptake among high-risk men in Zambia, and VMMC programs may consider similar interventions suited to their context.

COVID-19 and tobacco cessation: lessons from India.

OBJECTIVES: The Government of India prohibited the sale of tobacco products during the COVID-19 lockdown to prevent the spread of the SARS-CoV-2 virus. This study assessed the tobacco cessation behaviour and its predictors among adult tobacco users during the initial COVID-19 lockdown period in India. METHODS: A cross-sectional study was conducted with 801 adult tobacco users (both smoking and smokeless tobacco) in two urban metropolitan cities of India over a 2-month period (July to August 2020). The study assessed complete tobacco cessation and quit attempts during the lockdown period. Logistic and negative binomial regression models were used to study the correlates of tobacco cessation and quit attempts, respectively. RESULTS: In total, 90 (11.3%) tobacco users reported that they had quit using tobacco after the COVID-19 lockdown period. Overall, a median of two quit attempts (interquartile range 0-6) was made by tobacco users. Participants with good knowledge on the harmful effects of tobacco use and COVID-19 were significantly more likely to quit tobacco use (odds ratio [OR] 2.2; 95% confidence interval [CI] 1.2-4.0) and reported more quit attempts (incidence risk ratio 5.7; 95% CI 2.8-11.8) compared to those with poor knowledge. Participants who had access to tobacco products were less likely to quit tobacco use compared to those who had no access (OR 0.3; 95% CI 0.2-0.5]. CONCLUSIONS: Access restrictions and correct knowledge on the harmful effects of tobacco use and COVID-19 can play an important role in creating a conducive environment for tobacco cessation among users.

Investigations of seasonal outbreaks of acute encephalitis syndrome due to Orientia tsutsugamushi in Gorakhpur region, India: A One Health case study.

Gorakhpur division consisting of Gorakhpur and neighboring districts Deoria, Kushinagar and Maharajganj in Uttar Pradesh, India, have been witnessing seasonal outbreaks of acute encephalitis syndrome (AES) among children for the last three decades. Investigations conducted during 2005 identified Japanese encephalitis (JE) virus as an aetiology of AES. With the introduction of JE vaccination and other control strategies, the incidence of JE in the region declined, however, outbreaks of acute febrile illness with neurological manifestations continued to occur. Subsequent investigations identified Orientia tsutsugamushi, as the major aetiology of AES outbreaks in the region. This review details clinical, epidemiological, animal and entomological investigations conducted for AES due to O. tsutsugamushi during 2015 and 2017 in Gorakhpur region. Surveillance of acute febrile illness among children attending peripheral health facilities identified scrub typhus as an important aetiology of febrile illness during monsoon and post-monsoon months. Population-based serosurveys indicated high endemicity of scrub typhus. Entomological studies demonstrated natural infection of O. tsutsugamushi in small animal hosts and vector mites. Children acquired this infection through recent exposure to outdoor environment, while playing, or visiting fields or defecating in open fields. A few of the children with scrub typhus progress to develop CNS manifestations. Hence, early administration of appropriate antibiotics is crucial in preventing progression of AFI due to scrub typhus to AES. The investigations conducted by the multi-disciplinary team helped understand the transmission dynamics of scrub typhus in Gorakhpur division and recommend strategies for its control.

Reasons for under-reporting of paraquat poisoning in India.

Background Paraquat is an inexpensive herbicide used in agriculture because it is easily available and the cost of labour for manual clearance of weeds is prohibitive. Paraquat is toxic to human beings and is also used for committing suicide. We studied the reasons for under-reporting of paraquat poisoning including those related to the training of doctors. Methods In this mixed-methods study, we describe a series of patients with paraquat poisoning. We recorded their demographic data, clinical features, treatment and outcome with an intention to explore the reason for an initial misdiagnosis. We also explored whether deficiencies in curricula contributed to the misdiagnosis. Results The patients of paraquat poisoning (n=28) were mostly young illiterate men driven by impulsive behaviour rather than chronic depression. Paraquat was consumed by patients from non-agricultural background as well, implying easy access to the poison. Many patients could not name the agent and so initial treatment was directed at organophosphorus poisoning. The diagnostic signs included paraquat tongue, renal failure and jaundice. Most of the casualty medical officers and residents were unfamiliar with the symptoms and signs of paraquat poisoning as was evident by their answers to the questionnaire. Knowledge of medical students about paraquat poisoning was not assessed in the theory examinations and viva. Conclusion Factors contributing to the limitation in establishing the diagnosis are illiteracy and ignorance of the patients, lack of specific signs and lack of training of medical officers in treating patients with paraquat poisoning.

Diversity of rotavirus genotypes circulating in children < 5 years of age hospitalized for acute gastroenteritis in India from 2005 to 2016: analysis of temporal and regional genotype variation.

BACKGROUND: From 2016, the Government of India introduced the oral rotavirus vaccine into the national immunization schedule. Currently, two indigenously developed vaccines (ROTAVAC, Bharat Biotech; ROTASIIL, Serum Institute of India) are included in the Indian immunization program. We report the rotavirus disease burden and the diversity of rotavirus genotypes from 2005 to 2016 in a multi-centric surveillance study before the introduction of vaccines. METHODS: A total of 29,561 stool samples collected from 2005 to 2016 (7 sites during 2005-2009, 3 sites from 2009 to 2012, and 28 sites during 2012-2016) were included in the analysis. Stools were tested for rotavirus antigen using enzyme immunoassay (EIA). Genotyping was performed on 65.8% of the EIA positive samples using reverse transcription- polymerase chain reaction (RT-PCR) to identify the G (VP7) and P (VP4) types. Multinomial logistic regression was used to quantify the odds of detecting genotypes across the surveillance period and in particular age groups. RESULTS: Of the 29,561 samples tested, 10,959 (37.1%) were positive for rotavirus. There was a peak in rotavirus positivity during December to February across all sites. Of the 7215 genotyped samples, G1P[8] (38.7%) was the most common, followed by G2P[4] (12.3%), G9P[4] (5.8%), G12P[6] (4.2%), G9P[8] (4%), and G12P[8] (2.4%). Globally, G9P[4] and G12P[6] are less common genotypes, although these genotypes have been reported from India and few other countries. There was a variation in the geographic and temporal distribution of genotypes, and the emergence or re-emergence of new genotypes such as G3P[8] was seen. Over the surveillance period, there was a decline in the proportion of G2P[4], and an increase in the proportion of G9P[4]. A higher proportion of mixed and partially typed/untyped samples was also seen more in the age group 0-11 months. CONCLUSIONS: This 11 years surveillance highlights the high burden of severe rotavirus gastroenteritis in Indian children < 5 years of age before inclusion of rotavirus vaccines in the national programme. Regional variations in rotavirus epidemiology were seen, including the emergence of G3P[8] in the latter part of the surveillance. Having pre-introduction data is important to track changing epidemiology of rotaviruses, particularly following vaccine introduction.

Potential suitable habitat of Eleusine coracana (L) gaertn (Finger millet) under the climate change scenarios in Nepal.

BACKGROUND: Finger millet is the fourth major crop in Nepal and is cultivated in a traditional integrated subsistence system. Timely rain and appropriate temperature predominately affects crop distribution and yield. Climate change is evident in Nepal and it is imperative to understand how it affects habitat suitability of finger millet. Main objective of this study was to map the current suitable habitat and predicting the potential changes in the future under different climate scenarios in Nepal. Habitat mapping is important for maximizing production and minimizing the loss of local landraces. RESULTS: Maxent model was used in this study to quantify the current suitable habitat and changes in the future habitat suitability of finger millet, based on representative concentration pathways (RCP) (RCP 2.6, 4.5, 6.0 and 8.5) in two different time periods (2050 and 2070AD) using climatic predictive variables and species localities. The model shows that 39.7% (58512.71 km2) area of Nepal is highly suitable for finger millet, with cultivation mostly between 96 and 2300 m above sea level. Eastern and central parts of Nepal have more suitable areas than western parts. Our research clearly shows that the future climatic suitable area of finger millet would shrink by 4.3 to 8.9% in 2050 and 8.9-10.5% under different RCPs by 2070. CONCLUSION: Finger millet is mostly cultivated in mid-hill terraces. The substantial increase in temperature due to climate change may be one reason for decrease in habitat suitability of finger millet. This situation would further threat loss of local landraces of finger millet in the future. The findings can help in planning and policy framing for climate resilient smart agriculture practice.

Rotavirus gastroenteritis in Indian children < 5 years hospitalized for diarrhoea, 2012 to 2016.

BACKGROUND: In 2016, the Government of India introduced the oral rotavirus vaccine (ROTAVAC, Bharat Biotech, India) in 4 states of India as part of the Universal Immunization Programme, and expanded to 5 more states in 2017. We report four years of data on rotavirus gastroenteritis in hospitalized children < 5 years of age prior to vaccine introduction. METHODS: Children from 7 sites in southern and northern India hospitalized for diarrhoea were recruited between July 2012 and June 2016. Stool samples were screened for rotavirus using enzyme immunoassay (EIA). The EIA positive samples were genotyped by reverse-transcription polymerase chain reaction. RESULTS: Of the 5834 samples from the 7 sites, 2069 (35.5%) were positive for rotavirus by EIA. Genotyping was performed for 2010 (97.1%) samples. G1P[8](56.3%), G2P[4](9.1%), G9P[4](7.6%), G9P[8](4.2%), and G12P[6](3.7%) were the common genotypes in southern India and G1P[8](36%), G9P[4](11.4%), G2P[4](11.2%), G12P[6](8.4%), and G3P[8](5.9%) in northern India. CONCLUSIONS: The study highlights the high prevalence of rotavirus gastroenteritis in India and the diversity of rotavirus genotypes across different geographical regions. Pre- vaccine surveillance data is necessary to evaluate the potential change in admission rates for gastroenteritis and circulating rotavirus genotypes after vaccine introduction, thus assessing impact.

Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol.

BACKGROUND: ROTAVAC, an indigenous rotavirus vaccine, was introduced in the universal immunization program of India in four states in 2016 and expanded to five more states in 2017. The clinical trial on efficacy of ROTAVAC did not detect an increased risk of intussusception, but the trial was not large enough to detect a small risk. This protocol paper describes the establishment and implementation of a surveillance system to monitor the safety of rotavirus vaccine and investigate the potential infectious etiologies of intussusception. METHODS: This is a multi-centric hospital-based active surveillance being conducted at 28 hospitals in nine states of India. Data gathered from surveillance will be used to assess the risk of intussusception after ROTAVAC administration and to determine the infectious etiologies of intussusception. For safety assessment of ROTAVAC vaccine, children aged less than two years with intussusception admitted at the sentinel hospitals are enrolled into surveillance, a case report form completed, and a copy of the vaccination card obtained. The risk of intussusception following rotavirus vaccination will be assessed using a self-controlled case-series design. The investigation for potential infectious etiologies of intussusception is through a matched case-control design. Children enrolled for the safety assessment serve as cases and for each case, an age, gender and location matched control is enrolled within 30 days of case enrollment. Stool specimens are obtained from cases and controls. All forms and specimens are sent to the referral laboratory for data entry, analysis, multiplexed molecular testing, and storage. DISCUSSION: Anticipated public health benefits of this surveillance include the generation of information useful to national government on safety of vaccine and to make future decisions on vaccine use through risk-benefit analysis. Investigating infectious agents may help to determine the potential infectious etiologies of intussusception.

Biomarker and histopathological responses of Lates calcarifer on exposure to sub lethal concentrations of chlorpyrifos.

Bioassay tests on fingerlings (3.0 ± 0.5cm) of euryhyaline fish Lates calcarifer were conducted using customized continuous flow through system and derived 96h acute toxicity value for chlorpyrifos (CPF). Based on the measured concentration of CPF mean median lethal concentration (LC50) of 1.07µg/l with lower and upper 95% confidence limits (0.95 and 1.19µg/l). No observed Effect Concentration (NOEC), Lowest Observed Effect Concentration (LOEC) and chronic values were found to be 0.4, 0.09 and 0.07µg/l respectively. Key biomarker enzyme activities such as esterase, superoxide dismutase and malate dehydrogenase were measured in whole body tissues of the fish fingerlings on exposure to sublethal toxicity of CPF resulting in inhibition of enzyme activities. Native gel electrophoresis revealed single isoform of SOD and MDH enzyme activities exhibiting time and concentration dependent inhibition. Interestingly, three isoforms of esterase activity were witnessed, two isoforms didn't show changes and one isoform was completely inhibited. The observed changes indicated continuous production of reactive oxygen species (ROS) in cells, affecting the integrity and function of cell membrane. Decreased MDH activity indicates reduction of ATP production in the mitochondria leading to susceptibility of fish fingerlings due to the imposed CPF toxicity. Histopathological changes are evident as physiological signatures of chemical interactions in the cell and are prominently used for the evaluation of toxic effects. Gills and eye tissues were selected considering the possible effects on respiratory surfaces and vision impairment. Their tissue sections were observed for changes in primary & secondary lamellae, and retina of the eye respectively. Prominent pathological lesions of gills and retina of the eye include degeneration of cells, fusion, lifting of epithelium and increased cellular space, detachment of pigment epithelium, fusion of photoreceptor cells, respectively on exposure to 30 days of sub lethal concentrations. CPF was found to be highly toxic, affecting the vital functions of respiration, vision and cellular activities leading to susceptibility of fish fingerlings.

Multi-angle ZnO microstructures grown on Ag nanorods array for plasmon-enhanced near-UV-blue light emitter.

Metal enhanced ultraviolet light emission has been explored in ZnO/Ag hybrid structures prepared by hydrothermal growth of multi-angled ZnO nanorods on slanted Ag nanorods array fabricated by the thermal evaporation technique. Slanted Ag nanorods are realized to be the stacking of non-spherical Ag nanoparticles, resulting in asymmetric surface plasmon resonance spectra. The surface roughness of Ag nanorod array films significantly influences the growth mechanism of ZnO nanorods, leading to the formation of multi-angled ZnO microflowers. ZnO/Ag hybrid structures facilitate the interfacial charge transfer from Ag to ZnO with the realization of negative shift in binding energy of Ag 3d orbitals by ∼0.8 eV. These high quality ZnO nanorods in ZnO/Ag hybrid nanostructures exhibit strong ultraviolet emission in the 383-396 nm region without broad deep level emission, which can be explained by a suitable band diagram. The metal enhanced photoluminescence is witnessed mainly due to interfacial charge transfer with its dependence on surface roughness of bottom layer Ag nanorods, number density of ZnO nanorods and diversity in the interfacial area between Ag and ZnO nanorods. The existence of strong ultraviolet light with minor blue light emission and appearance of CIE shade in strong violet-blue region by ZnO/Ag hybrid structures depict exciting possibilities towards near UV-blue light emitting devices.

Biochemical and Histopathological Changes Induced by Nickel in the Striped Mullet, Mugil cephalus (Linnaeus 1758).

The present study is focused on determining the acute and chronic toxicity of nickel (Ni) to fish fingerlings, Mugil cephalus. The 96-h median lethal concentration (LC50) for Ni was found to be 42.2 ± 3.9 mg L-1. Based on the chronic toxicity test for 30 days, "No Observed Effect Concentration", "Lowest Observed Effect Concentration" and "Chronic value" were found to be 2.9 ± 0.14, 4.7 ± 0.14 and 3.7 ± 0.14 mg Ni L-1, respectively. The activities of biomarker enzymes including esterase, superoxide dismutase and malate dehydrogenase showed differential expression and cellular anomalies like hyperplasia and detachment of bipolar cells from photoreceptor cells in the retina of eye of mullet. Cellular anomalies in the retina of fish eye affect the primary function of retina, which is to convert light energy into nerve impulses transferred to the brain via the optic nerve, leading to loss or poor vision.

Early diversification of sperm size in the evolutionary history of the old world leaf warblers (Phylloscopidae).

Sperm morphological traits are highly variable among species and are commonly thought to evolve by post-copulatory sexual selection. However, little is known about the evolutionary dynamics of sperm morphology, and whether rates of evolutionary change are variable over time and among taxonomic groups. Here, we examine sperm morphology from 21 species of Old World leaf warblers (Phylloscopidae), a group of generally dull, sexually monochromatic birds, which are known to have high levels of extra-pair paternity. We found that sperm length differs markedly across species, spanning about 40% of the range observed across a larger selection of passerine birds. Furthermore, we found strong support for an 'early-burst' model of trait evolution, implying that the majority of divergence in sperm length has occurred early in the evolutionary history of this clade with subsequent evolutionary stasis. This large early divergence matches the early divergence reported in ecological traits (i.e. body size and feeding behaviour). Our findings demonstrate that rates of evolution in sperm morphology can change over time in passerine taxa, and that evolutionary stasis in sperm traits can occur even in species exhibiting characteristics consistent with moderate-to-high levels of sperm competition. It remains a major challenge to identify the selection mechanisms and possible constraints responsible for these variable rates of sperm evolution.

Immunogenicity & safety of a single dose of live-attenuated Japanese encephalitis vaccine SA 14-14-2 in adults.

BACKGROUND & OBJECTIVES: Japanese encephalitis (JE) caused by mosquito-borne Flavivirus is one of the leading causes of viral encephalitis in Asia. Control strategies include vector control and human vaccination. Due to lack of immunization programmes in endemic regions, there are still high mortality and morbidity. A live-attenuated SA 14-14-2 JE vaccine (LAJEV) has been licensed and used in Asian countries, including India. We report the assessment of immunogenicity and safety of the vaccine in adults during the first mass adult vaccination campaign carried out in Assam, India. METHODS: One thousand and seventy five adults (aged ≥15 yr) who received LAJEV were monitored for adverse events following immunization for one year. The safety assessment of vaccinated population was evaluated till 28 days and at 6 and 12 months. Blood samples collected from the enrolled participants were tested by plaque reduction neutralization test (PRNT 50 ) to assess the neutralizing antibody titres (NATs) before vaccination and 28 days, six and 12 months post-vaccination (PV). RESULTS: Among the 1075 vaccinated individuals, four reported minor adverse effects from 30 min to 28 days PV. Based on the pre-vaccination NAT, the study participants were categorized as seronegative, moderately seropositive and strongly seropositive. Nearly 85.5 per cent of JE seronegative participants seroconverted by 28 days PV. The geometric mean titre (GMT) in all the three groups increased by 28 days and decreased by six and 12 months PV. Nearly 60 per cent of the moderately positive individuals exhibited four-fold rise in GMT, 28 days PV. Almost 95.5 per cent of the participants in the study population remained seroprotected at the end of 12 months PV. INTERPRETATION & CONCLUSIONS: This study on immunogenicity and safety of LAJEV in adults showed that a single dose of the live-attenuated vaccine was safe and induced protective immunity to both JE seronegative and naturally seropositive adults. Further study is required to find out long term protective efficacy of this vaccine.

International open trial of uniform multidrug therapy regimen for leprosy patients: Findings & implications for national leprosy programmes.

BACKGROUND & OBJECTIVES: Uniform therapy for all leprosy patients will simplify leprosy treatment. In this context, we evaluated six-month multidrug therapy (MDT) currently recommended for multibacillary (MB) patients as uniform MDT (U-MDT) in a single-arm open trial under programme conditions. Primary objective was to determine efficacy to prevent five-year cumulative five per cent relapse. Secondary objectives were to assess acceptability, safety and compliance. METHODS: Newly detected, treatment-naive leprosy patients were enrolled in India (six sites) and P. R. China (two sites). Primary outcome was clinically confirmed relapse of occurrence of one or more new skin patches consistent with leprosy, without evidence of reactions post-treatment. Event rates per 100 person years as well as five-year cumulative risk of relapse, were calculated. RESULTS: A total of 2091 paucibacillary (PB) and 1298 MB leprosy patients were recruited from the 3437 patients screened. Among PB, two relapsed (rate=0.023; risk=0.11%), eight had suspected adverse drug reactions (ADRs) (rate=0.79) and rate of new lesions due toreactions was 0.24 (n=23). Rates of neuritis, type 1 and type 2 reactions were 0.39 (n=37), 0.54 (n=51) and 0.03 (n=3), respectively. Among MB, four relapsed (rate=0.07; risk=0.37%) and 16 had suspected ADR (rate=2.64). Rate of new lesions due to reactions among MB was 1.34 (n=76) and rates of neuritis, type 1 and type 2 reactions were 1.37 (n=78), 2.01 (n=114) and 0.49 (n=28), respectively. Compliance to U-MDT was 99 per cent. Skin pigmentation due to clofazimine was of short duration and acceptable. INTERPRETATION & CONCLUSIONS: We observed low relapse, minimal ADR and other adverse clinical events. Clofazimine-related pigmentation was acceptable. Evidence supports introduction of U-MDT in national leprosy programmes. [CTRI No: 2012/ 05/ 002696].