Vandana Kulkarni, MS

Pune, India
Role: 
Staff
Laboratory Manager
Vandana Kulkarni, MS

Vandana Kulkarni has a master’s degree in microbiology and has completed the Professional Development Program for Quality Assurance and Regulatory Affairs in Biopharmaceutical Industry.

Ms. Kulkarni is Laboratory Manager at Byramjee Jeejeebhoy Government Medical College Clinical Research Site (BJMC-CRS) in collaboration with Johns Hopkins University, Baltimore, USA, where she has worked since September of 2004. During the last 11 years, she has worked in the research laboratory providing lab support to NIH-funded ACTG and IMPAACT trials as well other studies.

She is responsible for the overall operations of the research laboratory and for supervision of laboratory staff comprising laboratory supervisors and technicians, and evaluates personnel competency and proficiency as well as waste management, vendor development for instrument purchase, and maintenance contracts. She also is responsible writing and revising all laboratory standard operating procedures (SOPs), for training staff in new methodologies as required, and for ensuring that laboratory and staff operate under Good Clinical Laboratory Practices. Additionally she conducts method/instrument validations, ensures that periodic EQA evaluations and methodology improvements are conducted to ensure that quality control and quality assessment programs are established and maintained, maintains the specimen repository and coordinates international shipping, lab documentations, and is responsible for annual audit to the Division of AIDS, NIAID, NIH. She is also responsible for procuring import and export permits for lab. Her prior experience includes quality control, microbiological testing, antibiotic and vitamin assays, and toxicity and sterility testing in the pharmaceutical industry. She has undergone GCLP, IATA and LDMS trainings.

Prevalence of gestational diabetes (GDM) and postpartum diabetes (DM) and their risk factors at Sassoon General Hospital and Byramjee Jeejeebhoy Government Medical College in Pune, India

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2021-12-19
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Primary objective: To determine the prevalence of GDM in a population of women in our hospital To identify the risk factors for GDM and determine the prevalence of GDM risk factors in a population of women screened for GDM and their association with GDM To determine the incidence and time course of...

Childhood ‘Omics’ and Mycobacterium tuberculosis-derived BiOsignatures (COMBO) for TB diagnosis

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2021-10-18
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The overall objective of the project is to identify Mtb- and/or host-derived biosignatures in children that can achieve World Health Organization (WHO) target product profile (TPP) accuracy thresholds for a non-sputum biomarker-based triage or diagnostic test for childhood TB. We hypothesize that...

A Nanopore Biosensor for Leveling MTB Antigens in Blood

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2021-04-01
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Purpose of the study: The inability to obtain diagnostically useful sputum specimens, or the inability to analyze non-sputum specimens, is a significant contributor to poor diagnostic sensitivity of current TB assays, leading to the WHO to call for the development of non-sputum-based biomarker or...

Pharmacokinetic Assessment of MDR-TB Drugs in the Treatment of TB Meningitis

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2020-08-23
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Rationale: MDR-TBM is a devastating disease with high mortality and severe neurologic sequelae among survivors. We recognize the importance of sufficient drug concentrations at the site of infection for efficacy of anti-TB drugs and believe it is likely that drug distribution into brain and CSF...

Identification of Biomarkers That Can Predict Progression from Latent Tuberculosis Infection to Active Tuberculosis Disease

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2020-08-23
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Purpose: The C-TRIUMPH study has identified 20 household contacts (HHC), who have progressed to active TB from its HHCs cohort (Cohort B). Immunological profiling of TB antigen induced biosignatures, profiling of transcriptional and proteomic biosignatures should provide novel insights into the...

Epidemiology and Clinical Outcomes of COVID-19 in India (ECO-19)

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2020-07-09
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This study was terminated May 25, 2021 This is a prospective cohort study of adults with suspected COVID-19 to address key knowledge gaps in the epidemiology of disease severity and poor clinical outcomes in India. Results from this study may help clinicians in India focus limited health resources...

Pregnancy Associated Immune Responses to Tuberculosis and HIV in India and South Africa (PARTHISA)

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2020-01-14
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Dr. Jyoti Mathad is Co-PI of this study. Purpose: Tuberculosis (TB) is a leading cause of maternal mortality, especially among HIV-infected women. Women are most likely to develop active TB during and immediately after pregnancy. The immunologic conditions responsible for this phenomenon are not...

Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy for TB (IMPAACT4TB)

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2019-12-17
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Primary Objective: This study is being conducted in Brazil, Cambodia, China, Ethiopia, Ghana, Haiti, India, Indonesia, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. The overall goal is to reduce TB incidence among (1) people living with HIV who are on antiretroviral therapy, and...

Markers of Lung Impairment in HIV-TB Coinfected Indian Adults

Post Date: 
2019-12-11
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Objectives/Aims We will compare the degree of lung impairment between HIV-TB co-infected adults (HIV-TB group) and TB cases without HIV co-infection (TB group) who successfully complete TB therapy. We hypothesize that the HIV-TB group will have a greater degree of lung...

T Cell Biomarkers and T-regulatory Responses to Pediatric TB

Post Date: 
2019-11-21
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The goals of this study are to: Validate host T cell biomarkers for diagnosis of pediatric TB Investigate the phenotype and functions of T-regulatory cells in pediatric TB We will use cryopreserved PBMC samples from CTRIUMPH cohorts: Pediatric unconfirmed TB, confirmed TB, latest Tb, and no TB...

Inflammasome Genetics and Tuberculosis Treatment Outcomes

Post Date: 
2019-11-07
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Dr. Amita Gupta is a Co-PI on this study. STUDY DESIGN We will conduct a retrospective case-cohort study nested within the CTRIUMPH and EDOTS cohorts to address our study objectives. This will enable us to measure the association of polymorphisms with multiple clinical outcomes simultaneously and...

Evaluation of a Urinary Biomarker Assay for Diagnosis and Test of Cure for Tuberculosis

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2019-09-09
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Dr. Jeff Tornheim is PI of this study. METHODS This study will make use of biorepository samples from the Cohort for TB Research by the Indo-US Medical Partnership (CTRIUMPh). CTRIUMPh, funded by the US NIH and Indian Department of Biotechnology, is an academic collaboration between Johns Hopkins...

Visual Field Loss in HIV-Positive Patients of Non-Infectious HIV Retinopathy

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2019-06-02
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New study will assess HIV+ patients and determine the prevalence of visual field loss due to noninfectious HIV retinopathy

Prevalence of Tuberculosis in Severely Malnourished Indian Children

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2018-12-18
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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. PIs are Robert Bollinger, MD, MPH; Dr. Muralidhar Tambe, BJGMC Severely malnourished children are vulnerable population for communicable and non-communicable...

Host RNA Expression for Diagnosis and Monitoring of Pediatric TB in Africa and India

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2018-12-13
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We are leveraging the RePORT platform by including a cohort of Indian children together with South African children in a large validation study to study on changes in gene expression profiles during treatment for TB

Immune Responses and Effect of Disulfiram on MTB Infected PBMCs as a Potential Host Directed Therapy

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2018-11-26
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Dr. Mandar Paradkar is lead investigator for this study that is assessing the immune responses of adult pulmonary TB patients enrolled in the CTRIUMPh study, using PBMC samples of those with harmful use of alcohol assessed by AUDIT scores ≥ 8 compared to non-alcoholics (AUDIT < 8). Aim 1: To...

Characterization of TB-specific T Cell Responses in Highly-exposed, but Uninfected Health Care Workers in India

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2018-10-25
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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. PIs are Robert Bollinger, MD, MPH; Jyothi Rengarajan, MD, Emory University. Primary Research Question Do health care workers who remain TST...

Vaginal Microbiota in HIV Infected and Uninfected Pregnant Women (Stand Alone)

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2018-10-16
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Amita Gupta, MD, MHS, and Shilpa Naik, MD, are PIs for this study; Rupak Shivakoti, PhD, MSPH, is Co-Investigator The makeup of vaginal microbiota is dynamic and may play a role in the birth outcomes of pregnant women. While HIV and pregnancy both uniquely impact vaginal microbiota, the impact of...

Assessment of Depression and Anxiety among HIV-infected Adolescents in Pune, India

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2018-07-22
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This study is conducted under the TREAT Asia Network and funded by amfAR. PURPOSE The purpose of this study is to estimate the prevalence of depression and anxiety among adolescents living with HIV in India and their determinants. DESIGN...

Evaluating the Source of Neonatal Bloodstream Infections due to Classically Hospital Acquired Pathogens in the Neonatal Intensive Care Unit in Pune, India

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2018-07-12
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This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. The PIs for this study are Dr. Julia Johnson of Johns Hopkins and Dr. Shilpa Naik of BJGMC. CoPIs...

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Concomitant pulmonary disease is common among patients with extrapulmonary TB

Post Date: 
2022-08-12
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International Journal of Tuberculosis and Lung Disease
Dr. Shivakumar and his group discovered that a high proportion of patients classified as EPTB in India have concomitant PTB. Their results support the need for improved symptom and CXR screening, and recommends routine sputum TB microbiology screening of all Indian patients with EPTB.

Clinical and Immunological Markers of Pulmonary Impairment among People with HIV(PWH) in India

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2022-05-12
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Open Forum Infectious Diseases
Background Despite anti-retroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods 210 adult PWH receiving antiretroviral...

Baseline IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes: a multi-site discovery and validation study

Post Date: 
2021-11-08
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The European Respiratory Journal
Dr. Akshay Gupte and colleagues discovered that elevated IL-6 can predict poor treatment outcomes, showcasing a need for including IL-6 in clinical screenings.

Unhealthy alcohol use independently associated with unfavorable TB treatment outcomes among Indian men

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2021-03-10
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International Journal of Tuberculosis and Lung Disease
This study by Samyra Cox and colleagues highlights the need for integrating effective alcohol interventions into TB care.

Systemic Inflammation in Pregnant Women With Latent Tuberculosis Infection

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2021-01-27
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Frontiers in Immunology
Background: Recent studies in adults have characterized differences in systemic inflammation between adults with and without latent tuberculosis infection (LTBI+ vs. LTBI-). Potential differences in systemic inflammation by LTBI status has not been assess in pregnant women. Methods: We conducted a...

Measuring TB drug levels in the hair in adults and children to monitor drug exposure and outcomes

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2021-01-01
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International Journal of Tuberculosis and Lung Disease
INTRODUCTION: Testing for anti-TB drugs in small hair samples may serve as a non-invasive tool to measure cumulative drug exposure and/or adherence, as these determine treatment success. We aimed to assess how well hair assays of TB drugs predict TB treatment outcomes.METHODS: A small thatch of...

Association of Vegetable and Animal Flesh Intake with Inflammation in Pregnant Women from India

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2020-12-08
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MDPI
In pregnant women, studies are lacking on the relationship of vegetable and animal flesh (poultry, red meat and seafood) intake with inflammation...

Integration of metabolomics and transcriptomics reveals novel biomarkers in the blood for tuberculosis diagnosis in children

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2020-11-11
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Scientific Reports
Pediatric tuberculosis (TB) remains a major global health problem. Improved pediatric diagnostics using readily available biosources are urgently needed. We used liquid chromatography-mass spectrometry to analyze plasma metabolite profiles of Indian children with active TB (n = 16) and age- and sex...

Tuberculosis preventive treatment should be considered for all household contacts of pulmonary tuberculosis patients in India

Post Date: 
2020-07-29
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PLoS One
PLoS One: Dr. Mandar Paradkar and colleagues conducted a CTRIUMPH study that supports TB preventive therapy for all household contacts of pulmonary TB patients in India

Intensified short symptom screening program for Dengue infection during pregnancy, India

Post Date: 
2020-04-15
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Emerging Infectious Diseases
Mosquitoborne diseases (e.g., malaria, dengue, and chikungunya) are endemic to India and pose diagnostic challenges during pregnancy. We evaluated an intensified short symptom screening program in India to diagnose dengue during pregnancy. During October 2017-January 2018, we screened pregnant...

Transcriptomic profiles of confirmed pediatric tuberculosis patients and household contacts identifies active tuberculosis, infection, and treatment response among Indian children

Post Date: 
2019-12-04
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Journal of Infectious Diseases
Journal of Infectious Diseases: Gene expression profiles among Indian children with confirmed TB were distinct from those of adults, highlighting the importance of including distinct populations in differential gene expression models

Lipid mediators of inflammation and resolution in individuals with tuberculosis and tuberculosis-diabetes

Post Date: 
2019-11-11
Publication: 
Prostaglandins and Other Lipid Mediators
Individuals with concurrent tuberculosis (TB) and Type 2 diabetes (DM) have a higher risk of adverse outcomes. To better understand potential immunological differences, we utilized a comprehensive panel to characterize pro-inflammatory and pro-resolving (i.e., mediators involved in the resolution...

MAL adaptor (TIRAP) S180L polymorphism and severity of disease among tuberculosis patients

Post Date: 
2019-10-31
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Infection, Genetics, and Evolution
Infection, Genetics, and Evolution : We investigated the association of TIRAP variants with severity of TB disease and IP-10 production in humans, which may be useful in predicting poor clinical outcome

Infection free "resisters" among household contacts of adult pulmonary tuberculosis

Post Date: 
2019-07-18
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PLoS One
Despite substantial exposure to infectious pulmonary tuberculosis (TB) cases, some household contacts (HHC) never acquire latent TB infection (LTBI). Characterizing these "resisters" can inform who to study immunologically for the development of TB vaccines. We enrolled HHCs of culture-confirmed...

Age-specific prevalence of TB infection among household contacts of pulmonary tuberculosis: Is it time for TB preventive therapy?

Post Date: 
2019-06-21
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Transactions of the Royal Society of Tropical Medicine and Hygiene
BACKGROUND: Household contacts (HHCs) of TB patients are at high risk of developing evidence of latent TB infection (LTBI) and active disease from the index patient. We estimated the age-specific prevalence of LTBI and the force of infection (FI), as a measure of recent transmission, among HHCs of...

Subtherapeutic rifampicin concentration is associated with unfavourable tuberculosis treatment outcomes

Post Date: 
2019-05-10
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Clinical Infectious Diseases
Rifampicin concentrations were sub-therapeutic in most Indian patients taking a thrice-weekly TB regimen

Elevated highly sensitive C-reactive protein and d-dimer levels are associated with food insecurity among people living with HIV in Pune, India

Post Date: 
2019-03-04
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Public Health Nutrition
Abstract OBJECTIVE: To assess the prevalence and determinants of food insecurity among people living with HIV (PLWH) in Pune, India and its association with biomarkers known to confer increased risks of morbidity and mortality in this population. DESIGN:...

Drug-resistant Enterobacteriaceae colonization is associated with healthcare utilization and antimicrobial use among inpatients in Pune, India

Post Date: 
2018-10-04
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BMC Infectious Diseases
BACKGROUND: Healthcare exposure may increase drug-resistant Enterobacteriaceae colonization risk. Nascent antimicrobial stewardship efforts in low- and middle-income countries require setting-specific data. We aimed to evaluate risk factors for inpatient drug resistant...

The association of household fine particulate matter and kerosene with tuberculosis in women and children in Pune, India

Post Date: 
2018-09-07
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Occupational and Environmental Medicine
Use of kerosene cooking fuel is positively associated with TB in women and children in our analysis using reported sources of exposure.

The effect of diabetes mellitus on the pharmacokinetics and pharmacodynamics of tuberculosis treatment

Post Date: 
2018-08-20
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Antimicrobial Agents and Chemotherapy
DM and higher HbA1c increased the risk of not achieving therapeutic targets for pyrazinamide, but higher pyrazinamide concentrations were asociated with worse microbiologic and clinical outcomes

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Research Update: TB Trials Conducted by JHU-India Team Will Shorten Drug-Susceptible TB Treatment for Children and Adults

Post Date: 
2020-12-07
Research Updated
Reporting from the virtual 51st Union Conference on Lung Health, the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) announced promising findings from 2 TB trials

Indo-Hopkins Partnership Seeks Causes of Sepsis in the NICU

Post Date: 
2017-08-10
Sepsis among newborns in the neonatal intensive care unit (NICU) is a big problem in India, and a complex one to untangle.

Advancing Global TB Research through RePORT

Post Date: 
2016-02-29
Regional Prospective Observational Research for Tuberculosis (RePORT) International is a large, international tuberculosis research effort being undertaken by 4 regional consortia: RePORT Brazil, RePORT South Africa, RePORT Indonesia, and RePORT India. While each region collects and maintains...

Tuberculosis test may underreport in pregnant women with HIV

Post Date: 
2016-01-28
Source: 
Infectious Disease Advisor
Pregnancy may confound tuberculosis (TB) tests results in women with HIV, according to research published in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine .

Tuberculosis scare in HIV positive pregnant women: most widely-used tuberculosis test fails to diagnose illness

Post Date: 
2016-01-28
Source: 
International Business Times
The most commonly-used tuberculosis (TB) test, TST, has failed to detect TB in HIV positive pregnant women. A research published online in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine has revealed that the TB test failed to accurately diagnose the...