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.

Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non contrast CT among PLHIV in Pune, India

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2022-11-25
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Primary objective Determine the prevalence of pulmonary nodules, including lung cancer using NCCT. Determine the risk of pulmonary nodules, including lung cancer using NCCT. Evaluate the association of smoking, immune suppression, ART, and TB with the prevalence and risk of NCCT-diagnosed pulmonary...

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

Post Date: 
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

Post Date: 
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

Post Date: 
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)

Post Date: 
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)

Post Date: 
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)

Post Date: 
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

Post Date: 
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

Post Date: 
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

Post Date: 
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

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

Post Date: 
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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Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial

Post Date: 
2023-09-13
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Lancet Child Adolescent Health
Deferral of maternal isoniazid preventive therapy to early postpartum had no effect on infant tuberculosis acquisition in our trial population, regardless of the diagnostic test used.

Challenges with the use of Xpert HPV as a screening tool for oral HPV among people living with HIV (PLHIV): experiences from Pune, India

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2023-05-04
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BMC Infectious Diseases
Background: People living with HIV (PLHIV) are at higher risk for human papillomavirus (HPV)-related oropharyngeal cancers compared to the general population. Xpert HPV test is a polymerase chain reaction (PCR) assay capable of rapid HPV detection. Performing the assay requires minimal intervention...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV (PLWH)

Post Date: 
2023-04-21
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Diabetes & Metabolic Syndrome
Background People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

The Kynurenine / Tryptophan Ratio is a Sensitive Biomarker for the Diagnosis of Pediatric Tuberculosis among Indian Children

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2022-12-22
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Frontiers in Immunology
Objectives: Pediatric tuberculosis (TB) remains difficult to diagnose. The plasma kynurenine to tryptophan ratio (K/T ratio) is a potential biomarker for TB diagnosis and treatment response but has not been assessed in children. Methods: We performed a targeted diagnostic accuracy analysis of four...

Impact of pregnancy and HIV on LTBI diagnostics and MTB-induced immune response: a cohort study in Pune, India

Post Date: 
2022-11-01
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International Journal of Infectious Diseases
Background Accurate tuberculosis infection (TBI) tests are critical for pregnant women, especially those with HIV, who have a high risk of TB disease. Methods We enrolled interferon gamma release assay (IGRA)+ pregnant women with and without HIV in a longitudinal study, followed up at delivery and...

Clinical and Immunological Markers of Pulmonary Impairment Among People With HIV in India

Post Date: 
2022-10-06
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Open Form Infectious Diseases
Dr. Akshay Gupte and team found females were 7 times more likely to have restrictive spirometry pattern and 22 times more likely to have preserved ratio impaired spirometry, compared with men.

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.

Comparative immune responses to M. tuberculosis in individuals with latent infection or sterile protection against infection

Post Date: 
2022-07-13
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bioRxiv
Summary To identify immunologic targets for tuberculosis vaccines more efficacious than BCG, we investigated the immune responses that differentiate individuals with sterile protection against M. tuberculosis (Mtb) infection (TB-resisters) from those who develop latent tuberculosis infection (LTBI-...

Smokeless tobacco use and oral potentially malignant disorders among people living with HIV (PLHIV) in Pune, India: Implications for oral cancer screening in PLHIV

Post Date: 
2022-07-13
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PLOS ONE
Introduction In India, smokeless tobacco (SLT) is a predominant form of tobacco used among people living with HIV (PLHIV). Despite SLT being a risk factor for oral potentially malignant disorders (OPMDs), no prior studies have quantified the association of OPMDs with SLT use among PLHIV. This...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV in Pune, Western India

Post Date: 
2022-07-01
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Diabetes & Metabolic Syndrome: Clinical Research & Reviews
Background: People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

Assessing tuberculosis risk in pregnant women from the PRACHITi study using transcriptomics

Post Date: 
2022-06-10
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Clinical Infectious Diseases
A new tuberculosis (TB) diagnostic cartridge assay, which detects a 3-gene TB signature in whole blood, was not diagnostic in women with maternal TB disease in India (area under the curve [AUC] = 0.72). In a cohort of pregnant women, we identified a novel gene set for TB diagnosis (AUC = 0.97) and...

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...

Clinical and Immunological Markers of Pulmonary Impairment among People Living with HIV in India

Post Date: 
2022-05-11
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Open Forum Infectious Diseases
Background Despite antiretroviral 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 Two hundred ten adult PWH receiving...

Host lipidome and tuberculosis treatment failure

Post Date: 
2022-01-06
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European Respiratory Journal
Introduction: Host lipids play important roles in tuberculosis (TB) pathogenesis. Whether host lipids at TB treatment initiation (baseline) affect subsequent treatment outcomes has not been well characterised. We used unbiased lipidomics to study the prospective association of host lipids with TB...

Impact of HIV status on systemic inflammation during pregnancy

Post Date: 
2021-11-15
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AIDS London
Objective: There are limited studies on the association of HIV infection with systemic inflammation during pregnancy. Design: A cohort study (N = 220) of pregnant women with HIV (N = 70) (all on antiretroviral therapy) and without HIV (N = 150) were enrolled from an...

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

Post Date: 
2021-11-08
Publication: 
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.

Immunologic effects of pregnancy on M. tuberculosis: methodology of an observational cohoStages of pregnancy and HIV affect diagnosis of tuberculosis infection and Mycobacterium tuberculosis (MTB)-induced immune response: Findings from PRACHITi, a cohort

Post Date: 
2021-09-21
Publication: 
International Journal of Infectious Diseases
Background Accurate tuberculosis infection (TBI) tests are critical for pregnant women, especially those with HIV, who have a high risk of TB disease. Methods We enrolled interferon gamma release assay (IGRA)+ pregnant women with and without HIV in a longitudinal study, followed up at delivery and...

Diabetes Mellitus and Tuberculosis Treatment Outcomes in Pune, India

Post Date: 
2021-04-01
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Open Forum Infectious Diseases
Background Diabetes mellitus (DM) increases the risk of tuberculosis (TB) disease. Knowledge of the impact of DM on TB treatment outcomes is primarily based on retrospective studies. Methods We conducted a prospective cohort study of new pulmonary TB patients with and without DM (TB-DM and TB only...

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

Post Date: 
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.

A two-gene signature for tuberculosis diagnosis in persons with advanced HIV

Post Date: 
2021-02-21
Publication: 
Frontiers in Immunology
Background: Transcriptomic signatures for tuberculosis (TB) have been proposed and represent a promising diagnostic tool. Data remain limited in persons with advanced HIV. Methods: We enrolled 30 patients with advanced HIV (CD4 <100 cells/mm3) in India; 16 with active TB and 14 without. Whole-...

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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...