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.

Zika Surveillance among Antenatal Clinic Outpatients in BJ Government Medical College and Sassoon General Hospitals, Pune, India

Post Date: 
2017-08-31
Country: 
India leads the world in dengue cases. CCGHE researchers are keeping an eye on Zika among pregnant women, which is transmitted by the same mosquito & can cause devastating birth defects.

TB and Pregnancy Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis: Nested Study on Investigating Maternal Antibodies to Modify Infant Tuberculosis Acquisition

Post Date: 
2017-08-29
Country: 
New study in Pune, India, aims to identify the profile of TB antibodies between mothers and infants, and to see if the presence of antibodies lowers risk of infant infection.

Antimicrobial Use and Diagnosis among Hospitalized Febrile Patients in Pune, India

Post Date: 
2017-08-07
Country: 
Antimicrobial resistance, a leading threat to human health, is enabled by unnecessary antibiotic use. Strategies to reduce unnecessary antibiotic use in India, the world’s largest antibiotic consumer, are urgently needed. Although most patients hospitalized in India with acute febrile illness...

Vaginal Microbiota in HIV Infected Pregnant Women

Post Date: 
2017-07-14
Country: 
Led by Dr. Rupak Shivakoti, this is a nested cross-sectional study of 30 HIV-infected and 60 non-HIV infected pregnant women. Pregnant women that are part of the parent study (“Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis” referred to as PRACHITI study from here on) will...

RePORT: C-TRIUMPH: Biomarkers for Tuberculosis Diagnosis and Treatment Response

Post Date: 
2017-03-24
Country: 
Aims: To develop non-sputum, blood-based tools for TB diagnosis and treatment, we urgently need biomarkers that identify active TB (ATB) cases and accurately distinguish them from latent TB infection (LTBI). Such biomarkers, when validated in diverse populations, can be developed into improved...

Prevalence and Risk Factors for Oral Cancer among HIV-Infected Adults

Post Date: 
2016-12-13
Country: 
The study is designed as a cross-sectional, single time point study for opportunistic oral cancer screening of HIV-infected and non- HIV adults 21 years or older in an urban hospital. All participants will undergo screening for oral cancer and oral potentially malignant disorders (OPMD) by visual...

RePORT: C-TRIUMPH: Substudy on Transcriptomic and Metabolomic Analysis of Microbiologically Confirmed Pediatric Tuberculosis Patients and Uninfected Household Contacts

Post Date: 
2016-09-01
Country: 
The objectives for this study are to: Assess the RNAseq, microRNA, and metabolic signature differences between confirmed pediatric TB patients and age- and sex-matched controls who are all household contacts of known cases but have remained TST and IGRA negative. Determine which of the published...

RePORT: C-TRIUMPH: Substudy on Comparison of Available Purified-protein Derivative (PPD) Tuberculin Skin Test (TST) Antigen Solutions in Detecting Latent Tuberculosis Infection in India

Post Date: 
2016-04-21
Country: 
Given the worldwide shortage of PPD TST antigen solutions, it is important to establish the sensitivity of the commercially available SPAN diagnostic TST when compared products used in international settings. This study aims to establish whether the SPAN diagnostic product is bioequivalent to PPDs...

RePORT: C-TRIUMPH: Substudy on Residual Respiratory Impairment Following Pulmonary Tuberculosis

Post Date: 
2015-09-13
Country: 
Many TB patients have residual respiratory impairment despite treatment. Such individuals may be at increased risk of chronic lung diseases and disability in the future. Using respiratory questionnaires and lung function tests, the Lung Health Sub-study will evaluate 400 adult TB patients enrolled...

Diagnosis of Tuberculosis Infection and Th1 Immune Response in Pregnant Women in India

Post Date: 
2014-09-01
Country: 
Tuberculosis (TB) disease is a major cause of mortality among Indian women of reproductive age; approximately 20-50% of women in India are latently infected with Mycobacterium tuberculosis (MTB). Due to immune changes of pregnancy, women are particularly at risk of reactivation and progression to...

TB and Pregnancy Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis

Post Date: 
2014-09-01
Country: 
Purpose: 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 understood. Our recent research shows that pregnant women...

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB Incidence Settings

Post Date: 
2014-04-01
Country: 
Dr. Amita Gupta is Protocol Chair for this multinational clinical trial being conducted in Botswana, Haiti, South Africa, Tanzania, Thailand, Uganda, and Zimbabwe, and in India by the Baltimore-Washington-India Clinical Trials Unit, of which CCGHE is a member. Background Tuberculosis (TB) is the...

RePORT: C-TRIUMPH: Cohort for Tuberculosis Research by the Indo-US Medical Partnership

Post Date: 
2013-09-28
Country: 
Collaboratively funded by the US NIH, India’s Department of Biotechnology [DBT], and Indian Council of Medical Research, the Cohort for TB Research by the Indo-US Medical Partnership (C-TRIUMPH) is an Indo-US research consortium that is part of RePORT India, a countrywide consortium for TB research...

RePORT: C-TRIUMPH: Substudy on Assessing the Association of Indoor Air Pollution with Tuberculosis in Adult Women and Children under 5 Years of Age

Post Date: 
2013-09-15
Country: 
Addressing social and environmental risk factors contributing to TB disease is becoming increasingly important for national TB programs. We are leveraging the pediatric participants in 1,100 homes participating in the C-TRIUMPH study, enhancing data collection regarding household and individual...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date: 
2007-02-02
Comprising clinical trial sites at Johns Hopkins Medicine in Baltimore, Whitman Walker Health in Washington, DC, and the BJGMC-CCGHE collaboration in Pune, India, the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU) is one of only 25 international HIV/TB clinical trial sites funded by the...

Cardiovascular risk in an HIV-infected population in India

Post Date: 
2017-07-03
Publication: 
Heart Asia
Country: 
Findings: HIV+ Indian patients who had cardiovascular disease at a younger age appear to be at imminent risk for morbidity.

Maternal syphilis: An independent risk factor for mother to infant human immunodeficiency virus transmission

Post Date: 
2017-06-15
Publication: 
Sexually Transmitted Diseases
Country: 
Abstract Syphilis is associated with increased human immunodeficiency virus acquisition and sexual transmission; we examined impact on human immunodeficiency virus mother-to-child transmission among mother-infant pairs enrolled in the India Six-Week Extended-Dose Nevirapine study. Maternal syphilis...

High prevalence of cryptococcal antigenaemia amongst asymptomatic advanced HIV patients in Pune, India

Post Date: 
2017-03-21
Publication: 
Indian Journal of Medical Microbiology
Country: 
Methods : A prospective study was conducted in a large public sector ART centre and the inpatient wards of Sassoon Hospital, Pune, India. All consenting patients> 18 years of age with CD4 count <100 cells/mm3 were screened for CrAg by latex agglutination assay. Those with positive CrAg...

Efficacy of six-week extended-dose nevirapine varies by infant birth weight with greatest relative efficacy in low birth weight infants

Post Date: 
2016-09-30
Publication: 
PLOS One
Country: 
Low birth weight (LBW), defined by the World Health Organization (WHO) as birth weight less than 2500 g, is a significant public health issue in resource-limited settings, particularly in Sub Saharan Africa and South Asia where the estimated annual incidence is 14% and 28–31%, respectively, and the...

Quantitative IFN-y,IL-2 response and latent tuberculosis test discordance in HIV-infected pregnant women

Post Date: 
2016-01-14
Publication: 
American Journal of Respiratory and Critical Care Medicine
Country: 
Rationale: Pregnant women with latent tuberculosis infection (LTBI) are at high risk for development of TB, especially if infected with HIV. Objectives: To assess the performance of LTBI tests in pregnant and postpartum women infected with HIV, investigate the immunology behind discordance in...

Vitamin D deficiency and risk of postpartum tuberculosis among HIV-infected breastfeeding mothers in India

Post Date: 
2015-03-15
Publication: 
International Journal of Tuberculosis and Lung Disease
Country: 
Some studies have associated low vitamin D levels with the risk of tuberculosis (TB), but its association in human immunodeficiency virus (HIV) infected mothers in a TB-endemic region has not been well studied. We conducted a nested 1:2 case-control study among HIV-infected mothers in western India...

Impact of maternal hepatitis B virus coinfection on mother-to-child transmission of HIV

Post Date: 
2014-07-15
Publication: 
HIV Medicine
Country: 
Objectives: Despite high hepatitis B virus (HBV) endemicity in various resource-limited settings (RLSs), the impact of maternal HIV/HBV coinfection on infant health outcomes has not been defined. We aimed to assess the prevalence of HBV coinfection among HIV-infected pregnant women and its impact...

Modifiable risk factors associated with tuberculosis disease in children in Pune, India

Post Date: 
2014-02-15
Publication: 
International Journal of Tuberculosis and Lung Disease
Country: 
Setting: India accounts for the largest burden of tuberculosis (TB) worldwide, with 26% of the world's cases. Objective: To assess the association between novel modifiable risk factors and TB in Indian children. Design: Cases were children aged ≤ 5 years with confirmed/probable TB based on World...

Patterns of TB drug-resistance in a tertiary care facility in Pune, India

Post Date: 
2013-07-18
Publication: 
Clinical Microbiology
Country: 
Introduction:Globally, the emergence of multi-drug resistant tuberculosis (MDRTB) (defined as resistance to isoniazid (INH) and rifampicin (RIF) and extensively drug resistant (XDR-TB) (defined as resistance to INH, RIF, any fluoroquinolone and to at least one of the three injectable second line...

Determination of a reference interval in a population

Post Date: 
2012-02-01
Publication: 
National Medical Journal of India
Country: 
The reference interval is the most widely used medical decision-making tool that separates healthy from diseased individuals. We briefly discuss the methods used to determine reference interval and its limitations.

Maternal tuberculosis: a risk factor for mother-to-child transmission of human immunodeficiency virus

Post Date: 
2011-02-01
Publication: 
The Journal of Infectious Diseases
Country: 
Background: Maternal human immunodeficiency virus (HIV) RNA load, CD4 cell count, breast-feeding, antiretroviral use, and malaria are well-established factors associated with mother-to-child transmission (MTCT) of HIV; the role of maternal tuberculosis (TB), however, has not been well established...

Nevirapine resistance and breast-milk HIV transmission: effects of single and extended-dose nevirapine prophylaxis in subtype C HIV-infected infants

Post Date: 
2009-01-01
Publication: 
PLOS One
Country: 
Background: Daily nevirapine (NVP) prophylaxis to HIV-exposed infants significantly reduces breast-milk HIV transmission. We assessed NVP-resistance in Indian infants enrolled in the “six-week extended-dose nevirapine” (SWEN) trial who received single-dose NVP (SD-NVP) or SWEN for prevention of...

The Indian pediatric HIV epidemic: a systematic review

Post Date: 
2008-09-15
Publication: 
Current HIV Research
Country: 
Despite an estimated 70,000 Indian children living with HIV infection, little is known about India's pediatric HIV epidemic. Generalizations about epidemiology, natural history, and treatment outcomes from other resource-limited settings (RLS) may be inaccurate for several biologic and social...

Low sensitivity of total lymphocyte count as a surrogate marker to identify antepartum and postpartum Indian women who require antiretroviral therapy

Post Date: 
2007-11-01
Publication: 
Journal of Acquired Immune Deficiency Syndromes
Country: 
Background: Some studies support the use of total lymphocyte count (TLC) as a surrogate marker for CD4 cell count to guide antiretroviral therapy (ART) initiation. However, most of these studies have focused on nonpregnant adults. In light of expanding ART access through prevention of mother-to-...

Clinically significant anemia in HIV-infected pregnant women in India is not a major barrier to zidovudine use for prevention of maternal-to-child transmission

Post Date: 
2007-06-01
Publication: 
Journal of Acquired Immune Deficiency Syndromes
Country: 
Objectives: To determine the prevalence of anemia (serum hemoglobin <10 g/dL) and assess zidovudine use and toxicity in HIV-positive pregnant women in India. Methods: From 2002 through 2006, 24,105 pregnant women in Pune were screened for HIV and anemia. As part of an infant prevention of mother...

Trends in Glycated Hemoglobin Levels and Implications for Diabetes Screening among Pulmonary Tuberculosis Cases Undergoing Treatment in India

Post Date: 
2017-09-13
Presentation Location: 
Rio de Janiero, Brazil
Country: 
Event & Convener: 
3rd Annual RePORT International Meeting, RICC
Poster Presentation. Gupte AN , Mave V, Meshram S, Lokhande R, Kadam D, Dharmshale S, Bharadwaj R, Kagal A, Pradhan N, Deshmukh S, Atre S, Sahasrabudhe T, Barthwal M, Meshram S, Kakrani A, Kulkarni V, Raskar S, Suryavanshi S, Shivakoti R, Chon S, Selvin E, Gupte N, Gupta A, Golub JE

High Burden of Dysglycemia among Contacts of Tuberculosis Patients in India: Is it Time to Screen Them All?

Post Date: 
2017-09-13
Presentation Location: 
Rio De Janiero, Brazil
Country: 
Event & Convener: 
RePORT International Conference, RICC
Poster Presentation. Shivakumar SVBY , Chandrasekaran P, Paradkar M, Danasekaran K, Kumar AMV, Ramachandran G, Thomas B, Suryavarshini N, Kohli R, Thiruvengadam K, Gupte N, Kulkarni V, Hannah LE, Gomathy NS, Pradhan N, Dolla CK, Gupte A, DeLuca A, Meshram S, Kagal AD, Golub J, Selvaraj K, Murali L...

Gene Expression Profiles of Pediatric Tuberculosis Patients and Exposed Controls from India

Post Date: 
2017-09-13
Presentation Location: 
Rio de Janiero, Brazil
Country: 
Event & Convener: 
RePORT International Conference. RICC
Poster Presentation. Tornheim JA , Paradkar M, Madugundu A, Gupte N, Kulkarni V, Sreenivasamurthy S, Raja R, Pradhan N, Shivakumar SVBY, Valvi C, Kohli R, Chandrasekaran P, Mave V, Pandey A, Gupta A.

Alcohol Use Among Adult Pulmonary and Extra-pulmonary TB Cases in the C-TRIUMPH India Cohort

Post Date: 
2017-02-03
Presentation Location: 
Hyderabad, India
Country: 
Event & Convener: 
6th Annual Regional Prospective Observational Research for Tuberculosis (RePORT) India Joint Leadership Meeting
Poster presentation. John S , DeLuca A, Paradkar M, Nayagam R, Shivakumar SVBY, Gupte A, Gupte N, Thomas B, Suryavanshi N, Kolhi R, Golub J, Kulkarni V, Pradhan N, Mave V, Chandrasekaran P, Gupta A

Impact of Immune Changes of Pregnancy and HIV Infection on Tuberculosis

Post Date: 
2017-02-03
Presentation Location: 
Hyderabad, India
Country: 
Event & Convener: 
6th Annual Regional Prospective Observational Research for Tuberculosis (RePORT) India Joint Leadership Meeting
Poster presentation. Mathad J, Alexander M , Bhosale R, Naik S, Shivakoti R, Mave V, Suryavanshi N, Gupte N, Kulkarni V, Pradan N, Patil N, Gupta A

Descriptive Baseline Characteristics, Treatment Outcomes and Biorepository of Pediatric TB Cases in CTRIUMPh-RePORT India Prospective Cohort

Post Date: 
2017-02-03
Presentation Location: 
Hyderabad, India
Country: 
Event & Convener: 
6th Annual Regional Prospective Observational Research for Tuberculosis (RePORT) India Joint Leadership Meeting
Poster presentation. Paradkar M , Kavitha D, Shiva Kumar SVBY, Khadse S, Khwaja S, Hari K, Rani N, Thiruvengadam K, Gupte N, Raskar S, Jain D, Suryavanshi S, Kohli R, Kulkarni V, Pradhan N, Sathyamurthi B, Tornheim J, Gupte A, DeLuca A, Mave V, Chandrasekaran P, Gupta A for the CTRIUMPH Study Team

IMPAACT P1078: Background, Design and Baseline Data

Post Date: 
2016-10-29
Presentation Location: 
Liverpool, England
Country: 
Event & Convener: 
47th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease.
Presentation. Mathad J on behalf of Gupta A and P1078 Study Team TB APPRISE: Phase IV Randomized Double-blind Placebo-controlled Trial to Evaluate the Safety of Immediate (Antepartum-initiated) vs. Deferred (Postpartum-initiated) Isoniazid Preventive Therapy among HIV-infected Women in High TB...

TB Infection Prevalence, Incidence and Risk Factors among Child and Adult Household Contacts of Adult TB Cases in India

Post Date: 
2016-10-27
Presentation Location: 
New Orleans, LA
Country: 
Event & Convener: 
ID Week 2016
Poster presentation. Shivakumar SVBY , Chandrasekaran P, Thiruvengadam K, Gupte N, Mave V, Hannah LE, Kulkarni V, Gupte A, Deluca A, Gomathy NS, Sathyamurthi P, Paradkar M, Kohli R, Meshram S, Kagal A, Suryavanshi N, Ramachandran G, Thomas B, Dolla CK, Subramanyam B, Golub J, Swaminathan S, Gupta A.

Etiology of Acute Febrile Illness among Hospitalized Adults and Children at a Public Tertiary-Care Center in Pune, India

Post Date: 
2016-10-27
Presentation Location: 
New Orleans, LA
Country: 
Event & Convener: 
ID Week 2016
Poster Abstract Session: Oh One World: Infections from Near and Far. Robinson M , Balasubramanian U, Raichur P, Kadam D, Khadse S, Marbaniang I, Kanade S, Sachs J, Basavaraj A, Bharadwaj R, Kinikar A, Kulkarni V, Kagal A, Gupta A, Mave V

The Association of Household Air Pollution and Tuberculosis in Women and Children in Pune, India

Post Date: 
2016-10-27
Presentation Location: 
Liverpool, England
Country: 
Event & Convener: 
46th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease.
Elf JL , Kinikar A, Khadse S, Mave V, Gupte N, Kulkarni V, Patekar S, Raichur P, Breysse PN, Gupta A, Golub JE.

A Case-control Study of Household Air Pollution and Tuberculosis in Women and Children in Pune, India

Post Date: 
2016-10-26
Presentation Location: 
Liverpool, England
Country: 
Event & Convener: 
46th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease
Oral Presentation. Elf JL , Kinikar A, Khadse S, Mave V, Gupte N, Kulkarni V, Patekar S, Raichur P, Breysse PN, Gupta A, Golub JE.

The Association of Household Air Pollution and Tuberculosis in Women and Children in Pune, India

Post Date: 
2016-09-22
Presentation Location: 
Durban, South Africa
Country: 
Event & Convener: 
RePORT International Meeting
Elf JL , Kinikar A, Khadse S, Mave V, Gupte N, Kulkarni V, Patekar S, Raichur P, Breysse PN, Gupta A, Golub JE. RePORT International Meeting. Durban, South Africa. 2016-07-14.

Frequent Resistant Gram Negative Rod Stool Colonization among Patients Admitted with Acute Febrile Illness in Pune, India

Post Date: 
2016-03-03
Presentation Location: 
Hyderabad, India
Country: 
Event & Convener: 
17th International Congress on Infectious Diseases
Poster Presentation. Bharadwaj RS, Robinson M, Marbaniang I, Kagal A, Raichur PA, Kulkami V, Balasubramanian U, Onawale P, Kanade S, Nelson G, Gupta A, Mave V.

The Association of Exposure to Air Pollution from Biomass Fuels, Kerosene, and Secondhand Tobacco Smoke with TB in Adult Women and Children in Pune, India

Post Date: 
2015-05-01
Presentation Location: 
Denver, CO
Country: 
Event & Convener: 
American Thoracic Society International Conference
Poster Session: Latent TB Infection: Diagnosis and Treatment. Oral Presentation. Elf JL , Kinikar A, Khadse S, Mave V, Gupte N, Kulkarni V, Patekar S, Raichur P, Breysse P, Gupta A, Golub J.

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 its...

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...