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result(s) for
"Sharma, Inderjit"
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A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants
by
Gairola, Sunil
,
Sharma, Inderjit
,
Khandgave, Prashant
in
631/250/590
,
692/308/2779/109/1942
,
692/308/2779/777
2024
A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and
Haemophilus influenzae
type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL
®
) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.
Clinical Trial Registration
–
CTRI/2019/11/022052
Journal Article
Vaccine Presentation and Packaging Advisory Group: a forum for reaching consensus on vaccine product attributes
by
Kristensen, Debra
,
Sharma, InderJit
,
Miranda, Gisele
in
Advisory Committees - organization & administration
,
Advisory groups
,
Avoidable
2013
In resource-constrained settings, getting vaccines safely and reliably to children in remote areas is a daily challenge. Exposure of vaccines to excessive heat or freezing temperatures, which often occurs in such settings, can compromise their potency. The Vaccine Presentation and Packaging Advisory Group (VPPAG) is an important forum where stakeholders from the vaccine industry and immunization programmes interact to discuss in depth vaccine product characteristics and their impact on immunization programmes. Already, the VPPAG has brought about meaningful changes in the way vaccines are packaged and presented for developing country programmes. Having a forum that allows constructive dialogue between the public and private sector furthers our shared goal of preventing disease, disability and death from vaccine-preventable diseases by designing products that can more easily reach those who will most benefit from immunization.
Journal Article
A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers
by
Gairola, Sunil
,
Sharma, Inderjit
,
Lalwani, Sanjay
in
Accreditation
,
Allergy and Immunology
,
Antibodies
2024
Combination vaccines are effective in simplifying complex vaccination schedules involving multiple vaccines. A fully liquid hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)- hepatitis B (HepB)-inactivated poliovirus (IPV)-Haemophilus influenzae b (Hib) vaccine (HEXASIIL®), manufactured by Serum Institute of India Pvt. Ltd. was tested for safety and immunogenicity following booster vaccination.
This was a phase-II/III, open label, multicentric, controlled trial in toddlers (phase II) and infants (phase III) in India. This manuscript presents results of phase II. Healthy toddlers aged 12–24 months were randomized (1:1) to receive a 0.5 ml booster dose of HEXASIIL® or comparator Pentavac SD + Poliovac, intramuscularly and followed for 28 days for safety assessment. Blood samples were collected pre-vaccination and 28 days post-vaccination to assess immunogenicity. Descriptive summary statistics were provided for safety and immunogenecity analyses.
A total of 223 subjects were randomized. One subject droped out prior to dosing, due to consent withdrawal. Thus, 222 subjects received study vaccine (110 HEXASIIL® and 112 comparator). Frequency of solicited adverse events was comparable between HEXASIIL® and comparator (85.5 % vs 90.2 %). Most local and systemic solicited AEs were mild to moderate in severity. All events resolved completely without any sequelae and none led to subject discontinuation. No vaccine related serious AE was reported. Post vaccination, seroprotection rates against tetanus, Hib and polio type 1 and 3 were 100 % in both the groups. Seroprotection rates for diphtheria (99.1 % vs 100 %) and polio type 2 (98.2 % vs 100 %) were observed in HEXASIIL® and comparator group, respectively. For Hepatitis B, seroprotection was >99 % in both groups. Seroconversion observed for Bordetella Pertussis (94.5 % vs 95.4 %) and Pertussis Toxin (77.1 % vs 87.2 %) in HEXASIIL® and comparator group, respectively.
HEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants.
Clinical Trial Registration – CTRI/2019/11/022052.
•Combination vaccines simplify vaccination schedules and improve compliance.•HEXASIIL® vaccine was compared to licensed DTwP-HepB-Hib + IPV vaccines.•HEXASIIL® had good safety and immunogenicity profile.•The data supported further evaluation of HEXASIIL® in infants.
Journal Article
Examining the Effect of Tax Reform Determinants, Firms’ Characteristics and Demographic Factors on the Financial Performance of Small and Micro Enterprises
by
Bhalla, Neba
,
Sharma, Rakesh Kumar
,
Kaur, Inderjit
in
Economic development
,
Economic growth
,
Economic theory
2022
Taxation is a powerful tool to achieve sustainable development goals (SDG) as tax policies help strengthen economic growth and improve revenue capacity. So, after tax reform, it is vital to analyze their impact on the performance of enterprises. Keeping in mind the SDG, the present study was conducted in India after the major tax overhaul—Goods and Service Tax (GST) on 1 July 2017, to measure the impact on Return on Equity (ROE) and Return on Investment (ROI) as they are the barometers to measure performance (DuPont Analysis). We opted for tax reform determinants, the characteristics of firms, demographic variables, and drivers from DuPont analysis to conduct the research, as all these variables can help identify the different causes of factors impacting ROI and ROE among different types of firms and demographics across countries. An econometric analysis of 546 registered SMEs (small and micro enterprises) was conducted using the regression model, structured equation modeling, and exploratory and confirmatory factor analysis to achieve the objectives. The empirical findings highlighted that a firm’s size, turnover, and DuPont analysis drivers (earnings × asset to sales × asset turnover) positively enhanced the ROI and ROE. Further, the change in the tax system after the tax reforms has enabled the detection of tax fraud and wrong invoices, reducing the missing insolvent traders and increasing the working capital flow of the firms, which in turn has augmented financial performance.
Journal Article
Effect of Goods and Service Tax System on Business Performance of Micro, Small and Medium Enterprises
by
Bhalla, Neba
,
Sharma, Rakesh Kumar
,
Kaur, Inderjit
in
Companies
,
Compliance
,
Economic conditions
2023
Tax and economy go hand in hand, and whenever any overhaul in tax structure takes place, it becomes essential to evaluate its effect on its sector and concerned businesses. The present study examines the effect of Goods and Service Tax (GST) on Indian Micro, Small and Medium Enterprises (MSMEs) business performance. Data were collected through a structured questionnaire from 404 registered MSMEs. The partial least square equation modeling results emphasized an overall positive impact of GST on business performance. The path model demonstrated that determinants of GST- change in the tax system, technology transition, and tax awareness and knowledge have enhanced the performance in terms of ease of doing business, operational efficiency, and increased profitability and have reduced the working capital blockage of funds. However, in contrast, the GST compliance system has increased the compliance burden on the firms, which harmed their performance. Further, the study examined that MSMEs’ size, turnover, and form impact the performance through the GST compliance system of the enterprises. The results may benefit the policymakers and other emerging economies in focusing on the tax reform factors which enhance the performance leading to better economic growth in the future with the support of MSMEs’ better performance.
JEL Code: H20; M10; O33; C30
Journal Article
Comparative Temporal Transcriptome Profiling of Wheat near Isogenic Line Carrying Lr57 under Compatible and Incompatible Interactions
by
Sharma, Tilak R.
,
Nahar, Natasha
,
Chhuneja, Parveen
in
Amino acids
,
Annotations
,
Biological activity
2016
Leaf rust caused by Puccinia triticina ( Pt ) is one of the most important diseases of bread wheat globally. Recent advances in sequencing technologies have provided opportunities to analyse the complete transcriptomes of the host as well as pathogen for studying differential gene expression during infection. Pathogen induced differential gene expression was characterized in a near isogenic line carrying leaf rust resistance gene Lr57 and susceptible recipient genotype WL711. RNA samples were collected at five different time points 0, 12, 24, 48, and 72 h post inoculation (HPI) with Pt 77-5. A total of 3020 transcripts were differentially expressed with 1458 and 2692 transcripts in WL711 and WL711+ Lr57 , respectively. The highest number of differentially expressed transcripts was detected at 12 HPI. Functional categorization using Blast2GO classified the genes into biological processes, molecular function and cellular components. WL711+ Lr57 showed much higher number of differentially expressed nucleotide binding and leucine rich repeat genes and expressed more protein kinases and pathogenesis related proteins such as chitinases, glucanases and other PR proteins as compared to susceptible genotype. Pathway annotation with KEGG categorized genes into 13 major classes with carbohydrate metabolism being the most prominent followed by amino acid, secondary metabolites, and nucleotide metabolism. Gene co-expression network analysis identified four and eight clusters of highly correlated genes in WL711 and WL711+ Lr57 , respectively. Comparative analysis of the differentially expressed transcripts led to the identification of some transcripts which were specifically expressed only in WL711+ Lr57 . It was apparent from the whole transcriptome sequencing that the resistance gene Lr57 directed the expression of different genes involved in building the resistance response in the host to combat invading pathogen. The RNAseq data and differentially expressed transcripts identified in present study is a genomic resource which can be used for further studying the host pathogen interaction for Lr57 and wheat transcriptome in general.
Journal Article
Multi-model statistical approaches for assessing the stability of Cicer interspecific derivatives in the trans and upper gangetic regions of India
2025
Chickpea productivity remains low due to limited genetic variability and susceptibility to biotic and abiotic stresses. To address these challenges, the introgression of novel genes from wild relatives and multi-environment evaluations are essential for identifying high-yielding, stable interspecific derivatives (ISDs). Despite the availability of several statistical tools, few chickpea studies have used a comprehensive multi-model approach for stability analysis. This study fills the void by applying four models- AMMI, GGE, WAASB, and MTSI for the first time in chickpea to evaluate multi-trait stability across diverse environments. 19 ISDs developed from four interspecific crosses (BGD 72 × ILWC 229, PBG 5 × ILWC 229, BGD 72 × ILWC 246, and PBG 5 × ILWC 246), along with two checks (PBG 7 and PBG 8), were evaluated across six environments. Trials were conducted over three consecutive
rabi
seasons (2020–2023) at Ludhiana (ENV1–ENV3), followed by multi-location testing during
rabi
2023–24 at Ludhiana (ENV4), Karnal (ENV5), and Kanpur (ENV6). Key yield traits, including number of pods per plant (NPP), 100-seed weight (HSW), and seed yield per plot (SYPP), were analyzed using all four models. Significant effects of genotype, environment, and genotype × environment interactions (GEIs) were detected through pooled ANOVA, and positive correlations were observed among all key traits. Genotypes GL21-1 (G1) and GL21-54 (G8) were superior performers with high trait values and stable performance across all environments, with yield variability up to 20% under stress-prone conditions. Among the models, GGE and WAASB were found effective for individual traits, while MTSI was superior for multi-trait selection. These promising ISDs can be released as high-yielding varieties or used as donor parents in climate-resilient chickpea breeding programs, addressing the rising global demand for chickpea production.
Journal Article
Einkorn genomics sheds light on history of the oldest domesticated wheat
2023
Einkorn (
Triticum monococcum
) was the first domesticated wheat species, and was central to the birth of agriculture and the Neolithic Revolution in the Fertile Crescent around 10,000 years ago
1
,
2
. Here we generate and analyse 5.2-Gb genome assemblies for wild and domesticated einkorn, including completely assembled centromeres. Einkorn centromeres are highly dynamic, showing evidence of ancient and recent centromere shifts caused by structural rearrangements. Whole-genome sequencing analysis of a diversity panel uncovered the population structure and evolutionary history of einkorn, revealing complex patterns of hybridizations and introgressions after the dispersal of domesticated einkorn from the Fertile Crescent. We also show that around 1% of the modern bread wheat (
Triticum aestivum
) A subgenome originates from einkorn. These resources and findings highlight the history of einkorn evolution and provide a basis to accelerate the genomics-assisted improvement of einkorn and bread wheat.
Around 1% of the A subgenome of modern bread wheat (
Triticum aestivum
) originates from einkorn (
Triticum monococcum
), the first domesticated wheat species.
Journal Article
Effect of Tax Knowledge and Technological Shift in Tax System on Business Performance: A PLS-SEM Analysis
by
Bhalla, Neba
,
Sharma, Rakesh Kumar
,
Kaur, Inderjit
in
Analysis
,
Compliance
,
Developing countries
2022
Taxes are imperative for the economy and businesses for better growth and development. Understanding the taxes and having the right approach towards them can make a vast difference between the success and failure of businesses. Therefore, the present paper aims to examine the impact of tax knowledge on business performance. The study is based on the primary survey of 450 registered Indian MSMEs. The empirical findings from the Partial Least Square Structure Equation Modeling highlight that tax knowledge enhanced operational efficiency and prevented firms from tax fraud. In addition, the technological advancement in the tax system and its knowledge led to proper tax administration and governance by firms which enhanced their productivity. The results may prove beneficial for policymakers, governments, and businesses because in-depth tax knowledge would lead to timely tax compliance and reduced tax evasion, avoidance, and scams.
Journal Article