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Principal investigator Betsy Herold, MD, been awarded a $12 million grant from the National Institutes of Health (NIH) to develop a drug-impregnated intravaginal ring to prevent HIV infection in women. Dr. Herold has worked extensively to translate laboratory research into effective real-world preventive measures for HIV. Read more>

Faculty in the Division of Pediatric Infectious Disease are involved in several basic, translational and clinical research projects.  Faculty are assisted in their research efforts by a clinical research nurse, Sonia Sheehan, and by undergraduate, graduate, and medical students;  residents; and postdoctoral fellows.  Current research projects include the following:

Title:  Drug at the Right Place & Concentration: Optimizing Vaginal Ring PrEP
Funding: NIH U19AI03461   
Objective:  Development of vaginal rings to protect adolescents and young women from HIV and herpes simplex viruses.  A clinical study is planned and will be conducted in the Bronx and Africa. 
Investigators:  Betsy Herold, Rebecca Pellett Madan and Marla Keller (Dept. of Medicine, Division of Infectious Diseases)

Title:  Intravaginal Ring Delivery of Safe & Effective Microbicides to Prevent HIV & HSV
Funding: NIH U19AI076980 
Objective:  Development and evaluation of the safety and efficacy of a vaginal ring designed to deliver tenofovir dispoproxil fumarate, the more potent prodrug of tenofovir, for prevention of HIV and HSV.  A Phase 1 safety and pharmacokinetic study was recently completed in the Bronx and plans are underway for further clinical advancement.
Investigators: Betsy Herold, Rebecca Pellett Madan and Marla Keller (Dept. of Medicine, Division of Infectious Diseases)

Title:  Impact of HSV-2 on female genital tract mucosal immunity
Funding:  NIH 2-AI065309 RO1
Objective: To identify the mechanisms that contribute to the HIV-HSV-2 syndemic
Investigators:  Betsy Herold, Harris Goldstein and Marla Keller (Dept. of Medicine, Division of Infectious Diseases

Title:  An HSV-2 Virus Deleted in Glycoprotein D Elicits "Sterilizing" Immunity
Funding:  Pending
Objective: Development of a novel vaccine to prevent HSV-1 and HSV-2. 
Investigators:  Betsy Herold and William Jacobs (Dept. of Microbiology-Immunology, Albert Einstein College of Medicine)

Title:  A Multicenter Consortium to Define the Epidemiology and Outcomes of  Viral Respiratory Infections in Pediatric Transplant Recipients 
Sponsor:  Pediatric Infectious Disease Society Transplant Working Group
Objective:  Define the epidemiology and outcomes of viral respiratory infections in hospitalized stem cell and solid organ transplant patients to promote the development of new treatments. 
Investigators:  Betsy Herold and Rebecca Pellett Madan

Title:   Immune responses to S. pneumoniae in pediatric solid organ transplant recipients
Funding:  Department of Pediatrics
Objective:  Examine immune responses to S. pneumoniae in pediatric transplant patient recipients and identify optimal timing of and need for pneumococcal reimmunization following transplantation.  This study utilizes samples and data collected as part of the Einstein-Montefiore Pediatric Transplant Biorepository.  
Investigators:  Rebecca Pellett Madan, Betsy Herold, Liise-Anne Pirofski (Dept. of Medicine, Chief, Division of Infectious Diseases)

Title:  Impact of CMV viremia on immune responses to opportunistic infections in pediatric transplant recipients
Funding:  Department of Pediatrics
Objective:  Examine immune responses to Epstein Barr virus, adenovirus, and S. pneumoniae among pediatric transplant recipients who develop CMV viremia. This study also utilizes samples and data collected through the Einstein-Montefiore Pediatric Transplant Biorepository.
Investigators:  Rebecca Pellett Madan, Betsy Herold

Title:  Genital mucosal immunity in HIV infected and uninfected adolescent women
Funding: K23 AI089271
Objective:  To uncover alterations of genital mucosal immunity that contribute to risk for sexually transmitted infections in HIV infected and uninfected adolescent females.
Investigators:  Rebecca Pellett Madan

Title:  Phase 1 safety and acceptability of tenofovir 1% gel in adolescent girls (Tenofovir in Adolescent Girls [TAG] Study)
Funding:  USAID/CONRAD A14-130
Objective:  To investigate the safety and acceptability of tenofovir 1% vaginal gel for the prevention of HIV in adolescent females.
Investigators: Rebecca Pellett Madan (Site Principal Investigator), Marla Keller (Dept. of Medicine, Division of Infectious Disease)

Title:  Acceptability of 1% tenofovir vaginal gel for prevention of HIV in adolescent females
Objective: Identify the key variables that determine acceptability and feasibility of coital-dependent vaginal gel products for HIV prevention in adolescent females.
Funding:  Pilot Studies Program of the HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute/Research Foundation for Mental Hygiene
Investigators:  Rebecca Pellett Madan, Laurie Bauman (Division of General Pediatrics), Joanne Mantell (Department of Psychiatry, Columbia University Medical Center)

Title:  Development of PPCM vaginal contraceptive microbicide
Funding: NIH R44 AI084225
Investigators:  Betsy Herold
Objective:  This SBIR grant is focused on the development of PPCM for prevention and/or treatment of herpes simplex virus

Title:  Phase 3 study of IV to oral tedizolid phosphate compared with standard of care in adolescents with complicated skin and soft structure infections
Funding: Cubist Pharmaceuticals/Merck
Objective: To assess the safety and efficacy of tedizolid for complicated skin infections
Investigators: Site Principal Investigator Tsoline Kojaoghlanian

Title:  An observational study to characterize RSV hospitalizations in premature infants
Funding: Astra Zeneca
Objective: To understand risk and cost of RSV hospitalizations in infants who did not receive palivizumab prophylaxis 
Investigators: Site Principal Investigator Tsoline Kojaoghlanian

Title: The contribution of fungi to the development of severe asthma in children
Funding: Division of Pediatric Infectious Diseases
Objective: To understand how the fungal microflora of the respiratory tract contributes to the development and severity of asthma in children.
Investigators:  David L.  Goldman and Alfin Vicencio (Department of Pediatrics, Mount School of Medicine). 

Title: The role of a serum protease in the host response to anthrax.
Objective:  To understand how a serum protease contributes to the innate host response to anthrax through the deactivation of B. anthracis toxins.
Investigators: David L. Goldman, Johanna Rivera (Department of Microbiology & Immunology), Arturo Casadevall (Department of Microbiology & Immunology, Johns Hopkins School of Medicine).

Title: Clostridium difficile colitis in children. 
Objective: To understand why neonates are inherently resistant to C. difficile colitis.  Investigators: David L. Goldman and Michelle Ewart (Department of Pathology).  

Title: A multi-center randomized, double blind, placebo controlled study on the effects of etanercept in children presenting with Kawasaki Disease
Funding: FDA (RO1 FD003526-0) with support from Amgen
Objective: Investigate the effect of etancercept compared to placebo in reducing adverse outcomes in children with Kawasaki disease who are treated with standard therapy.
Investigators: Iona Munjal, Nadine Choueiter (Division of Pediatric Cardiology) and Michael Portman (PI - Seattle Children’s Hospital),

CONRAD A14-130 Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females
Einstein IRB 2014-3853
NCT# NCT02245945
Site PI Rebecca Pellett Madan
Study contact: Rebecca Pellett Madan, MD
Rebecca.madan@einstein.yu.edu
718-741-2470
Einstein IRB 2008-548
"Genital mucosal immunity in HIV infected and uninfected adolescents"
Funding source: NIH/NIAID K23AI089271
PI and contact: Rebecca Pellett Madan
rebecca.madan@einstein.yu.edu
718-741-2470

Einstein IRB 2011-528
"Immune reconstitution in pediatric transplant recipients"
The Einstein-Montefiore Pediatric Transplant Biorepository
Funding source: Einstein Montefiore Department of Pediatrics
PI and contact: Rebecca Pellett Madan
rebecca.madan@einstein.yu.edu
718-741-2470

Einstein IRB 2013-351
"Modifiers of PrEP Efficacy: Impact of the vaginal microbiome and age"
PI: Betsy Herold
Contact: Dafnfa Rebibo
dafna.rebibo@einstein.yu.edu
718-430-3253

Protocol #: AstraZeneca D4800L00009
Title: The SENTINEL 1 Study: An Observational, Non-Interventional Study in the United States to Characterize Respiratory Syncytial Virus Hospitalizations among Infants Born at 29 to 35 Weeks Gestational Age Not Receiving Immunoprophylaxis
PI: Tsoline Kojaoghlanian, MD
Study team contact info: Tsoline Kojaoghlanian, Tel #: 718-741-2478; email: tkojaogl@montefiore.org
Sonia Sheehan, Study Coordinator, Tel #: 718-741-2484; email: ssheehan@montefiore.org

Protocol #: Cubist Pharmaceuticals Inc. TR701-122
Title: PHASE 3 STUDY OF IV TO ORAL 6-DAY TEDIZOLID PHOSPHATE COMPARED WITH 10-DAY COMPARATOR IN SUBJECTS 12 TO <18 YEARS WITH cSSTI
PI: Tsoline Kojaoghlanian, MD
Study team contact info:
- Tsoline Kojaoghlanian, Tel #: 718-741-2478; email: tkojaogl@montefiore.org
- Sonia Sheehan, Study Coordinator, Tel #: 718-741-2484; email: ssheehan@montefiore.org

IRB #: 09-02-063E
Title: The Utility of the Urine Pneumococcal Antigen Test in Pediatric Patients with Sickle Cell Disease
PI: Nathan Litman, MD
Study team contact info:
- Tsoline Kojaoghlanian, Tel #: 718-741-2478; email: tkojaogl@montefiore.org

IRB #: 12.09.340 (NB: Iona co PI with Cardiology on this so probably on their list?)•
NCT00841789 • Title: Etanercept in Kawasaki Disease
PI name: Michael Portman, Seattle Children’s •
Study team contact information Kelly Balem 718-741-2384

Fellows Research

1) Shust, GF, Cho, S., Kim, M, Madan, RP, Guzman, EM, Pollack, M, Epstein, J, Cohen, HW, Keller, JR, and Herold BC. Female genital tract secretions inhibit HSV infection: correlation with soluble mucosal immune mediators and impact of hormonal contraception. Am J Reproductive Immunology 63: 110-9, 2010.

2) Keller MJ, Mesquita PM, Torres NM, Cho S, Shust G, Madan RP, Cohen HW, Petrie J, Ford T, Soto-Torres L, Profy AT, Herold BC. Postcoital bioavailability and antiviral activity of 0.5% PRO 2000 gel: implications for future microbicide clinical trials. PLoS One. Jan 22;5(1):e878, 2010.

3) Long CB, Madan RP, Herold BC. Diagnosis and management of community-associated MRSA infections in children. .Expert Rev Anti Infect Ther. Feb;8(2):183-95, 2010.

4) Keller, JM, Madan, RP, Torres, NM, Fazzari, MJ, Cho, S, Kalyoussef, S, Mesquita, PMM, Louissant, N, Chen, J, Cohen, HW, Diament, EC, Lee, AC, Soto-Torres, L, Hendrix, CW and Herold, BC. A randomized trial to assess anti-HIV activity in female genital tract secretions & soluble mucosal immunity following application of 1% tenofovir gel. PLoS One Jan 25;6(1)e16475, 2011.

5) Patel, M, Stefanidou, M, Long, CB, Fazzari, M, Tesfa, L, Del Rio, M, Lamour J, Ricafort ,R, Madan, RP, and Herold BC. Dynamics of cell-mediated immune responses to cytomegalovirus in pediatric transplantation recipients. Pediatric Transplantation 2011 Jul 18. doi: 10.1111/j.1399-3046PMID:21762326

6) Verma, NA, Lee, AC, Herold, BC and Keller, MJ. Topical prophylaxis for HIV prevention in women: becoming a reality. Current HIV/AIDS Reports, 2011: 8: 104-113.

7) Long, CB, Ramos, I, Rastogi D, Manwani,D, Janow, G, Del Rio, M, Mayers, M, Herold, BC* Ferenandez-Sesma, A* and Madan, RP* (*senior authors contributed equally). Humoral and cell-mediated immune responses to monovalent 2009 influenza A/H1N1 and seasonal trivalent influenza vaccines in high-risk children. J Peds Jan;160(1):74-81, 2012, PMID:21840537

8) Keller, MJ, Madan, RP, Shust, G, Carpenter, C, Torres, NM, Cho, S, Khine, H, Huang, M-L, Corey, L, Kim, M, and Herold, BC. Changes in the soluble mucosal immune environment during genital herpes outbreaks. JAIDS, 2012 Oct 1;6(2):194-202.

9) Kalyoussef, S, Nieves, E, Dinerman, E. Carpenter, C, Viswananthan, S, Oh, J, Burd, B. Angeletti, RH, Buckheit KW, Fredricks, DN, Madan RP, Keller, MJ, and Herold, BC. Lactobacillus proteins are associated with bactericidal activity against E. coli of female genital tract secretions. PLoS One, 2012;7(11):e49506.

10) Dezzutti, CS, Hendrix, CS, Marrazzo, J, Pan, Z, Wang, L, Louissaint, N, Kalyoussef, S, Torres, NM, Hladik, F, Parikh, U, Mellors, J, Hillier, SL and Herold, BC. Performance of swabs, lavage, and diluents to quantify biomarkers of female genital tract soluble mucosal mediators. PLoS One;6(8):e23136. Epub 2011 Aug 12 PMID:21858008

11) Madan, RP, Carpenter, CC, Fiedler, T, Kalyoussef, S, McAndrew, C., Shankar, V, Kim, M, Keller, MJ, Fredricks, DN, and Herold, BC.  Altered biomarkers of mucosal immunity and reduced vaginal lactobacillus concentrations in sexually active female adolescents.  PLoS One, 2012, 7(7):e40415.

12) Mues, MB, Cheshenko, N., Wilson, DW, Gunther-Cummins, L., and Herold, B.C. Dynasore disrupts trafficking of HSV proteins. J Virol 2015 Jul 1;89(13):6673-84.

13) Nakra, N., Madan, RP, Buckley, N, Huber, AM, Freiermuth, JL, Espinoza, L, Walsh, J, Parikh, UM, Penrose, KJ, Keller, MJ, and Herold, BC. Loss of innate host defense following unprotected vaginal sex. J Infec Dis, in press (2015)

14)Goldman-Yassen AE, Mony VK, Arguin PM, Daily JP. Higher Rates of Misdiagnosis in Pediatric Patients Versus Adults Hospitalized With Imported Malaria. Pediatr Emerg Care. 2014 Oct 15. [Epub ahead of print]

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