Can We Do More With Less While Building Predictive Models? A Study in Parsimony of Risk Models for Predicting Heart Failure Readmissions.

Hospital readmission due to heart failure is a topic of concern for patients and hospitals alike: it is both the most frequent and expensive diagnosis for hospitalization. Therefore, accurate prediction of readmission risk while patients are still in the hospital helps to guide appropriate postdischarge interventions. As our understanding of the disease and the volume of electronic health record data both increase, the number of predictors and model-building time for predicting risk grow rapidly. This suggests a need to use methods for reducing the number of predictors without losing predictive performance. We explored and described three such methods and demonstrated their use by applying them to a real-world dataset consisting of 57 variables from health data of 1210 patients from one hospital system. We compared all models generated from predictor reduction methods against the full, 57-predictor model for predicting risk of 30-day readmissions for patients with heart failure. Our predictive performance, measured by the C-statistic, ranged from 0.630 to 0.840, while model-building time ranged from 10 minutes to 10 hours. Our final model achieved a C-statistic (0.832) comparable to the full model (0.840) in the validation cohort while using only 16 predictors and providing a 66-fold improvement in model-building time.

Substituent Effect on Absorption and Fluorescence Properties of Thieno[3, 2-c]Pyridine Derivatives.

New substituted thieno[3,2-c]pyridine derivatives 5 were synthesized by the reaction of 3-bromo-4-chlorothieno[3,2-c]pyridine 1 with cyclic amine 2, which further on Suzuki reaction with boronic acids 4 converted to corresponding 3-arylthieno[3,2-c]pyridine 5. Substituent R3 has predominant effect on fluorescence properties of thienopyridines. However, the electron donor amine at C4 has no effect on fluorescence properties of thienopyridines. Graphical Abstract New thieno[3,2-c]pyridine derivatives were synthesized from 3-bromo-4-chlorothieno[3,2-c]pyridine and cyclic amines, which by on Suzuki reaction with boronic acids converted to corresponding 3-arylthieno[3,2-c]pyridine. Substituent R3 has predominant effect on fluorescence properties of thienopyridines. However, the electron donor amine at C4 has no effect on fluorescence properties of thienopyridines.

A review of three cases of mobile blast: The new culprit of hand injury.

Although blast injuries are common with war; cooking gas; firecracker, mobile phone blast cases are increasing in number in last couple of years. We present 3 cases of mobile blast in 3 children causing injury to dominant hand in them.

A review of 48 patients after bear attacks in Central India: Demographics, management and outcomes.

INTRODUCTION: Bear attacks though relatively rare are frequent enough to be of concern for those who are in bear habitats. Our centre at Nagpur, being surrounded by dense forests from all the sides, treats a large number of victims. AIM: The aim was to document the injuries, management and the potential complications of bear attacks. MATERIALS AND METHODS: We reviewed the records of 48 consecutive patients who were treated in our department from January 2006 to December 2013 for bear attacks. OUTCOME: The majority of patients were referred 24-48 h post-attack. All but two patients had involvement of either the face or scalp. Involvement of eyes, mandible, facial nerve, was common. Reconstruction included simple suture of lacerations to management of complex compound injuries with three-dimensional defects. Thirteen patients developed infection. CONCLUSION: Bear attack victims need a multidisciplinary approach. Early broad spectrum antibiotics, anti-rabies prophylaxis and irrigation and debridement of the wound are needed. We advise early referral to tertiary treatment centres.

Congenital urethrocutaneous fistula in an adolescent male.

A urethrocutaneous fistula is a common complication after hypospadias repair, but congenital fistula is a rare anomaly. We present a 16-year-old boy with this unusual anomaly. Its etiology, embryology, and management are discussed in brief.

Mining for class-specific motifs in protein sequence classification.

BACKGROUND: In protein sequence classification, identification of the sequence motifs or n-grams that can precisely discriminate between classes is a more interesting scientific question than the classification itself. A number of classification methods aim at accurate classification but fail to explain which sequence features indeed contribute to the accuracy. We hypothesize that sequences in lower denominations (n-grams) can be used to explore the sequence landscape and to identify class-specific motifs that discriminate between classes during classification. Discriminative n-grams are short peptide sequences that are highly frequent in one class but are either minimally present or absent in other classes. In this study, we present a new substitution-based scoring function for identifying discriminative n-grams that are highly specific to a class. RESULTS: We present a scoring function based on discriminative n-grams that can effectively discriminate between classes. The scoring function, initially, harvests the entire set of 4- to 8-grams from the protein sequences of different classes in the dataset. Similar n-grams of the same size are combined to form new n-grams, where the similarity is defined by positive amino acid substitution scores in the BLOSUM62 matrix. Substitution has resulted in a large increase in the number of discriminatory n-grams harvested. Due to the unbalanced nature of the dataset, the frequencies of the n-grams are normalized using a dampening factor, which gives more weightage to the n-grams that appear in fewer classes and vice-versa. After the n-grams are normalized, the scoring function identifies discriminative 4- to 8-grams for each class that are frequent enough to be above a selection threshold. By mapping these discriminative n-grams back to the protein sequences, we obtained contiguous n-grams that represent short class-specific motifs in protein sequences. Our method fared well compared to an existing motif finding method known as Wordspy. We have validated our enriched set of class-specific motifs against the functionally important motifs obtained from the NLSdb, Prosite and ELM databases. We demonstrate that this method is very generic; thus can be widely applied to detect class-specific motifs in many protein sequence classification tasks. CONCLUSION: The proposed scoring function and methodology is able to identify class-specific motifs using discriminative n-grams derived from the protein sequences. The implementation of amino acid substitution scores for similarity detection, and the dampening factor to normalize the unbalanced datasets have significant effect on the performance of the scoring function. Our multipronged validation tests demonstrate that this method can detect class-specific motifs from a wide variety of protein sequence classes with a potential application to detecting proteome-specific motifs of different organisms.

MetaID: a novel method for identification and quantification of metagenomic samples.

BACKGROUND: Advances in next-generation sequencing (NGS) technology has provided us with an opportunity to analyze and evaluate the rich microbial communities present in all natural environments. The shorter reads obtained from the shortgun technology has paved the way for determining the taxonomic profile of a community by simply aligning the reads against the available reference genomes. While several computational methods are available for taxonomic profiling at the genus- and species-level, none of these methods are effective at the strain-level identification due to the increasing difficulty in detecting variation at that level. Here, we present MetaID, an alignment-free n-gram based approach that can accurately identify microorganisms at the strain level and estimate the abundance of each organism in a sample, given a metagenomic sequencing dataset. RESULTS: MetaID is an n-gram based method that calculates the profile of unique and common n-grams from the dataset of 2,031 prokaryotic genomes and assigns weights to each n-gram using a scoring function. This scoring function assigns higher weightage to the n-grams that appear in fewer genomes and vice versa; thus, allows for effective use of both unique and common n-grams for species identification. Our 10-fold cross-validation results on a simulated dataset show a remarkable accuracy of 99.7% at the strain-level identification of the organisms in gut microbiome. We also demonstrated that our model shows impressive performance even by using only 25% or 50% of the genome sequences for modeling. In addition to identification of the species, our method can also estimate the relative abundance of each species in the simulated metagenomic samples. The generic approach employed in this method can be applied for accurate identification of a wide variety of microbial species (viruses, prokaryotes and eukaryotes) present in any environmental sample. CONCLUSIONS: The proposed scoring function and approach is able to accurately identify and estimate the entire taxa in any metagenomic community. The weights assigned to the common n-grams by our scoring function are precisely calibrated to match the reads up to the strain level. Our multipronged validation tests demonstrate that MetaID is sufficiently robust to accurately identify and estimate the abundance of each taxon in any natural environment even when using incomplete or partially sequenced genomes.

Immunogenicity and safety of Mebella™ vaccine developed by Human Biologicals Institute in a Phase II/III, randomized, multicentric, non-inferiority study.

BACKGROUND: The goal of 'Measles and Rubella Strategic Framework 2021-2030' is to make "A world free from measles and rubella". To be a part of this journey, Human Biologicals Institute has developed Mebella™ vaccine, which is a lyophilized Measles and Rubella (Live) vaccine. A randomized, single blind, comparative, multicenter Phase II/III trial was conducted to compare the immunogenicity and safety of Mebella™ vaccine with MR-VAC® vaccine in healthy subjects. METHODS: A total of 888 subjects were enrolled in four age groups (222 subjects in each group) of 18 years to 49 years; 2 years to below 18 years; 12 months to below 24 months; and 9 months to below 12 months of age. The subjects were randomized in 2:1 ratio to receive single dose of either Mebella™ vaccine of Human Biologicals Institute or MR-VAC® vaccine. Immunogenicity was assessed at 42 days after the vaccination and was compared between the vaccine arms in each group. Safety was also assessed and compared between the vaccine arms during the study period. RESULTS: A total of 875 subjects completed the study out of 888 enrolled subjects. The seroprotection rates, seroconversion rates, and geometric mean titres for both Measles and Rubella components of Mebella™ vaccine were found to be comparable and non-inferior to the MR-VAC® vaccine after 42 days of vaccination. Injection site pain was the most common local adverse event reported whereas fever was the only systemic adverse event reported in both the vaccine arms. No serious adverse event was reported. CONCLUSION: It was concluded from the study results that the test vaccine, Mebella™, was immunogenic and well tolerated and was non-inferior to the comparator vaccine, MR-VAC®, when administered to healthy subjects of 9 months to 49 years of age. Clinical Trial Registry of India Identifier: CTRI/2020/07/026930.

Augmented Reality Demonstration Survey Results From a Veteran Affairs Medical Center.

Background: Augmented reality (AR) has a wide range of potential applications to enhance health care. Understanding how the introduction of a new technology may impact employees is essential for overall health care system success. Methods: Survey responses were obtained before and after a health care-focused interactive AR demonstration at a US Department of Veterans Affairs (VA) medical center. Data were assessed with descriptive statistics, Wilcoxon signed rank matched pairs test, pooled t test, and analysis of variance. Results: A total of 166 individuals participated in the demonstration and survey. Statistically significant improvements were seen after the use of the new AR technology in each of the categories assessed using a 5-point Likert scale. Scores for perceptions of institutional innovativeness increased from 3.4 to 4.5 (a 22% increase; P < .001); employee excitement about the VA increased from 3.7 to 4.3 (a 12% increase; P < .001); and employee likelihood to continue working at VA increased from 4.2 to 4.5 (a 6% increase; P < .001). Subgroup analysis demonstrated statistically significant differences by employee veteran status, VA tenure, and sex. Respondents felt strongly that this type of work will positively impact health care and that the VA should continue these efforts. Conclusions: An AR demonstration significantly increased employee excitement and intention to continue employment at the VA and provided valuable insights about the most impactful uses of AR in health care.

Immunogenicity and safety of HavisureTM vaccine developed by Human Biologicals Institute in healthy subjects of 12 months to 49 years of age: A phase II/III, randomized, single blind, non-inferiority study.

BACKGROUND: Hepatitis A is an inflammation of the liver caused by the hepatitis A virus (HAV). It is transmitted mainly because of poor personal hygiene via the faecal/oral route through ingestion of contaminated food or water or through the direct contact with an infectious person. Though most of the infected individuals recover from the infection, a few may develop fatal fulminant hepatitis. In this randomized, multicenter study, immunogenicity and safety of Havisure™ vaccine of Human Biologicals Institute was compared with Havrix® vaccine. METHODS: The study was carried out in 528 eligible healthy subjects, in two age groups across eight centres in India. Group A included subjects of 19-49 years and Group B subjects of 12 months to below 19 years of age. All subjects received two doses of either Havisure™ vaccine or Havrix® vaccine as per randomization at six months interval. Blood samples for antibody titre estimation were collected before vaccination and 4-6 weeks after 2nd dose of vaccination. Immunogenicity was assessed by estimating seroconversion rate, seroprotection rate, and geometric mean titres of antibodies. Safety was evaluated by collection and analysis of data on solicited and unsolicited adverse events. RESULTS: Of 528 enrolled subjects, 493 subjects completed the study. There was 100% seroconversion and seroprotection in both the vaccine arms. There was no statistical difference in the geometric mean titres between the two vaccine arms. Pain and swelling at the site of injection were the most common local adverse events whereas fever and headache were the most common systemic adverse events observed in both vaccine arms. No serious adverse event was reported in the study. CONCLUSION: The study results indicate that the Havisure™ vaccine is immunogenic and safe when administered to healthy subjects of 12 months to 49 years of age, and is non-inferior to Havrix® Vaccine.

Growth of Bi2Te3 quantum dots/rods in glass: a unique highly stable nanosystem with novel functionality for high performance magneto optical devices.

Magneto optical materials are currently of great interest, primarily for modern applications in optical isolation, modulation and switching in telecommunication. However, single crystals are the benchmark materials still used in these devices which are rather expensive and very difficult to fabricate. In this context, we are reporting herewith a stable and novel Bi(2)Te(3) quantum dot-glass nanosystem obtained using a controlled thermo-chemical method. The Q-dots of hexagonal Bi(2)Te(3) of size 4 to 14 nm were grown along the <1 1 3> direction. Surprisingly, we obtained quantum rods of Bi(2)Te(3) of size 6 × 10 nm for the first time. The strong quantum confinement in the nanosystem is clearly shown by the optical study. The band gap of the host glass was drastically reduced (from 4.00 to 1.88 eV) due to the growth of Bi(2)Te(3) quantum dots whereas photoluminescence showed a Stokes shift ~175 meV. Faraday Rotation (FR) investigations of the Bi(2)Te(3) quantum dot-glass nanosystem show a nonlinear response in Verdet constant with a decrease in the Bi(2)Te(3) dot sizes. The Bi(2)Te(3) Q-dot-glass nanosystem with ~4 nm dots shows significant enhancement (70 times) in Verdet constant compared to the host glass and more radically better than conventional single crystal (TGG). This is the first time that such a type of unique nanosystem has been architectured and has given extremely good magneto-optical performance. We strongly feel that this novel nanosystem has tremendous applications in magneto-optical devices. It is noteworthy that expensive single crystals can be replaced with this cost effective novel glass nanosystem. Interestingly, the present quantum dot-glass nanosystem can be transformed into optical fibers very easily, which will have an exceptionally high impact on the fabrication of high performance magneto optical devices.

Data acquisition process for VA and non-VA emergency department and hospital utilization by veterans with spinal cord injury and disorders in California using VA and state data.

Context: To identify VA and non-VA Emergency Department (ED) and hospital utilization by veterans with spinal cord injury and disorders (SCI/D) in California.Design: Retrospective cohort study.Setting: VA and Office of Statewide Health Planning and Development (OSHPD) in California.Participants: Total 300 veterans admitted to the study VA SCI/D Center for initial rehabilitations from 01/01/1999 through 08/17/2014.Interventions: N/A.Outcome Measures: Individual-level ED visits and hospitalizations during the first-year post-rehabilitation.Results: Among 145 veterans for whom ED visit data available, 168 ED visits were identified: 94 (55.2%) at non-VA EDs and 74 (44.8%) at the VA ED, with a mean of 1.16 (±2.21) ED visit/person. Seventy-seven (53.1%) veterans did not visit any ED. Of 68 (46.9%) veterans with ≥ one ED visit, 20 (29.4%) visited the VA ED only, 34 (50.0%) visited non-VA EDs only, and 14 (20.6%) visited both VA and non-VA EDs. Among 212 Veterans for whom hospitalization data were available, 247 hospitalizations were identified: 82 (33.2%) non-VA hospitalizations and 165 (66.8%) VA hospitalization with a mean of 1.17 (±1.62) hospitalizations/person. One hundred-seven (50.5%) veterans had no hospitalizations. Of 105 veterans with ≥ one hospitalization, 58 (55.2%) were hospitalized at the study VA hospital, 15 (14.3%) at a non-VA hospital, and 32 (30.5%) at both VA and non-VA hospitals.Conclusion: Non-VA ED and hospital usage among veterans with SCI/D occurred frequently. The acquisition of non-VA healthcare data managed by state agencies is vital to accurately and comprehensively evaluate needs and utilization rates among veteran populations.

Effect of Dietary Amino Acids L-Arginine and Lysine on Implant Osseointegration.

Background: Low protein diets have been linked to decreased bone strength in humans. Arginine and lysine can help improve the healing process and stimulate growth factors. Aim: To evaluate if dietary arginine and lysine combination aids in reducing the time frame for osseo-integration process and bone formation in animal models. Materials and Methods: Controls (Group I) and Experimental (Group II) consisted of twelve New Zealand rabbits. Animals in the experimental group were fed a conventional pellet food, water, and the amino acids L-Lysine and L-Arginine (Biovea, USA), whereas those in the control group were offered a standard diet. In both groups of animals, titanium implants measuring 2.5mm* 6mm were implanted in each tibial osteotomy. At the end of two weeks, four weeks, and eight weeks, the animals were euthanized. The tibial bone was removed and preserved in 1% formalin. The samples were analysed histologically for presence or absence of Necrosis, presence or absence of clot formation, Vascularization, Fibroblast, Osteoblasts and Osteoid Bone growth. Results: Histological outcomes on vascularization, fibroblasts, osteoblasts, osteoid bone growth inferred no significant variation between the control and experimental groups after 8 weeks (P>.05). Conclusion: Vascularity, clot organisation, osteoblasts, fibroblasts, and osteoid bone production in the protein fed experimental group animals were better in initial stages of healing when compared to control groups.

Effect of aging on the shape and position of the eyebrow in an Indian population.

BACKGROUND: The eyebrow is one of the most important structures of the face from an aesthetic point of view. As age increases, the brow changes its shape and position. This age-related change decreases the vitality, youth, and expression associated with the aesthetically ideal face. This article describes changes in eyebrow position in Indian women with aging. METHODS: This study recruited 80 female subjects for each of the required age ranges (20-30 years and 50-60 years) from the staff and outpatient settings at a tertiary care center in central India. Women who had any condition that could affect the measurements were excluded from the study. Standardized digital photographs in frontal view were captured with the forehead and eyebrows in a maximally relaxed position and with the eyes open. Eyebrow position was determined by measuring from a reference horizontal plane drawn between the medial canthi to vertical points on the upper brow margin at the medial canthus, pupil, and lateral canthus. The result was statistically analyzed. RESULTS: With aging, the least rise was seen in the lateral segment, which was not statistically significant. This difference was statistically significant at the medial and midbrow positions (p < 0.05). In the younger group, the lateral brow position was significantly higher than the midbrow (p < 0.05). In contrast, the older group showed a nonsignificant difference in the position of the midbrow and the lateral brow. The mean horizontal distance of the brow apex from the midpoint of the pupil for young women was 15.2 mm. CONCLUSION: The study results imply that the brow does not drop in women with age. It is recommended that in most instances, the lateral brow should be preferentially elevated, whereas the medial brow should undergo minimal or no elevation. Most patients require brow reshaping by restoration of the brow apex lateral to the level of the outer corneal limbus. By comparing eyebrow shape and position in both young and mature women, this study provides objective data that can be used to plan forehead-rejuvenating procedures in Indian women.

The average Indian female nose.

BACKGROUND: This study aimed to delineate the anthropometric measurements of the noses of young women of an Indian population and to compare them with the published ideals and average measurements for white women. METHODS: This anthropometric survey included a volunteer sample of 100 young Indian women ages 18 to 35 years with Indian parents and no history of previous surgery or trauma to the nose. Standardized frontal, lateral, oblique, and basal photographs of the subjects' noses were taken, and 12 standard anthropometric measurements of the nose were determined. The results were compared with published standards for North American white women. In addition, nine nasal indices were calculated and compared with the standards for North American white women. RESULTS: The nose of Indian women differs significantly from the white nose. All the nasal measurements for the Indian women were found to be significantly different from those for North American white women. Seven of the nine nasal indices also differed significantly. CONCLUSIONS: Anthropometric analysis suggests differences between the Indian female nose and the North American white nose. Thus, a single aesthetic ideal is inadequate. Noses of Indian women are smaller and wider, with a less projected and rounded tip than the noses of white women. This study established the nasal anthropometric norms for nasal parameters, which will serve as a guide for cosmetic and reconstructive surgery in Indian women.

Aesthetic surgery: expanding horizons: concepts, desires, and fears of rural women in central India.

BACKGROUND: We are experiencing greater demand for aesthetic surgery from rural populations. The present study attempts to understand their concepts and beliefs. METHODS: A double-blinded survey with random sampling was done in 34 villages in central India. Sample population consisted of 1,000 unmarried rural women in the age range of 18-30 years. Subjects were interviewed in person and a questionnaire was filled out based on their response. RESULTS: The response rate was 87.2%. Of the 872 respondents, 829 (95%) were aware of aesthetic surgery. Television was the most common source of information (61%). Health-care providers were a source of information for 2.5% of respondents. Aesthetic surgery was associated with "some change in face" by 35.7% of subjects. Surprisingly, 29.1% associated aesthetic surgery with face transplantation. The need for aesthetic surgery was perceived by 85.7% respondents. The face was the most common part of the body perceived to require aesthetic surgery (40.9%). Fifty-seven percent of respondents failed to identify the procedure required for aesthetic correction. Of the 711 respondents who perceived the need for an aesthetic procedure, 83.8% were willing to undergo surgery. Improved marriage prospects were the most common reason for seeking surgery. Cost was the most important variable considered while choosing surgery (49.3%). Cost was also the most frequent response when asked about the biggest fear (63.1%). CONCLUSION: We recommend that scientific knowledge should be provided to the rural population, cost should be limited to a reasonable level, and the social needs of these patients should be fulfilled to ensure a greater reach of aesthetic procedures.

Anthropometry of the eyelid and palpebral fissure in an Indian population.

BACKGROUND: The shapes of the eyebrow and upper eyelid are distinctive facial landmarks. In cosmetic and reconstructive procedures, maintenance of the anatomical relations of these landmarks ensures a pleasing postoperative appearance. OBJECTIVES: The authors establish normal values for eyelid anthropometry in an Indian population. METHOD: This prospective study included 216 patients between the ages of 16 and 60 years, divided into three groups by age (Groups A to C: 16 to 30 years, 31 to 45 years, 46 to 60 years, respectively) and sex. All patients were photographed from a frontal view, with measurements taken from these photographs. Parameters included the distance between the medial canthus and the lateral canthus (ie, the width of the palpebral fissure), the distance between the open upper eyelid margin and the lower eyelid margin, (ie, the vertical dimension of the palpebral fissure), the intercanthal distance, the interpupillary distance, and the height of the open upper lid. All measured values were analyzed by independent t-test. RESULTS: There was a significant increase in palpebral fissure from Group B to Group C. A significant increase was also observed in intercanthal distance as age progressed beyond 45 years. There was a significant decrease in the interpupillary distance as age increased-from Group A to Group B and from Group B to Group C-and a similar increase in eyelid height in that age progression. CONCLUSIONS: The anatomy of the Indian population is distinct in that the palpebral fissure in men is less than that in women. It appears that changes in the eye become more pronounced after 45 years, including an increase in palpebral fissure, intercanthal distance, and height of the upper lid, along with a decrease in interpupillary distance.

Risk Factors for Readmissions After Total Joint Replacement: A Meta-Analysis.

¼: We performed a systematic review and meta-analysis of predictive modeling studies examining the risk of readmission after total hip arthroplasty (THA) and total knee arthroplasty (TKA) in order to synthesize key risk factors and evaluate their pooled effects. Our analysis entailed 15 compliant studies for qualitative review and 17 compliant studies for quantitative meta-analysis. ¼: A qualitative review of 15 predictive modeling studies highlighted 5 key risk factors for risk of readmission after THA and/or TKA: age, length of stay, readmission reduction policy, use of peripheral nerve block, and type of joint replacement procedure. ¼: A meta-analysis of 17 studies unveiled 3 significant risk factors: discharge to a skilled nursing facility rather than to home (approximately 61% higher risk), surgery at a low- or medium-procedure-volume hospital (approximately 26% higher risk), and the presence of patient obesity (approximately 34% higher risk). We demonstrated clinically meaningful relationships between these factors and moderator variables of procedure type, source of data used for model-building, and the proportion of male patients in the cohort. ¼: We found that many studies did not adhere to gold-standard criteria for reporting and study construction based on the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) and NOS (Newcastle-Ottawa Scale) methodologies. ¼: We recommend that these risk factors be considered in clinical practice and future work alike as they relate to surgical, discharge, and care decision-making. Future work should also prioritize greater observance of gold-standard reporting criteria for predictive models.

Safety and immunogenicity of inactivated hepatitis-A vaccine developed by Human Biologicals Institute in two age groups of healthy subjects: A phase I open label study.

BACKGROUND: Hepatitis-A is an acute viral infection of the liver. Hepatitis-A virus has worldwide spread and is endemic in India. Though the disease is self-limiting in most cases, outbreaks are reported frequently from both developing and developed countries of the world. Severity and fatality occur more among infected symptomatic adults. The infection can be prevented with proper and timely immunization. This phase I, single arm, open label, multicenter trial was designed to assess the safety and immunogenicity of the inactivated hepatitis-A vaccine developed by Human Biologicals Institute when administered in a single dose in two age groups of healthy subjects. METHODS: This study was carried out in 55 subjects in two healthy age groups at two centers in India. Group A included subjects of 19-49 years and group B subjects of 12-18 years of age. Enrolled subjects received a single dose of inactivated hepatitis A vaccine. Blood samples were collected at baseline and 4-6 weeks after vaccination. Safety was assessed by collection and analysis of data on solicited and unsolicited adverse events and immunogenicity was assessed by estimating the seroconversion rate, seroprotection rate and the geometric mean titres of antibodies. RESULTS: Among the 55 subjects enrolled, 15 reported adverse events. No serious adverse event was reported. Pain at the injection site was the lone local adverse event. Systemic adverse events reported in Group A were: fatigue, headache, diarrhoea, fever, anorexia, nausea and upper respiratory tract infection, whereas there was no systemic event reported in Group B. There was 100% seroconversion and seroprotection and significant rise in antibody titre levels were observed in both the groups post vaccination. CONCLUSIONS: This study found HBI inactivated hepatitis-A vaccine to be safe and highly immunogenic when administered as a single dose in adolescent and adult subjects.