Julie E. Ledgerwood, D.O.Building 10-CRC, Room 5-243610 Center DriveBethesda, MD 20892-1912Phone: 301-594-8502Fax: email@example.com
If you are interested in volunteering to participate in a clinical study, please call or email us.Phone: 1-866-833-LIFE (1-866-833-5433) Email: firstname.lastname@example.org.
Deputy Chief and Principal Investigator
Julie Ledgerwood, D.O., is the deputy chief of the Clinical Trials Core at the Vaccine Research Center (VRC). She is also a principal investigator for Phase I and II vaccine clinical trials at the VRC, studying the safety and immunogenicity of vaccines for HIV, biodefense, and emerging infectious diseases. Dr. Ledgerwood is the protocol chair of an Ebola, Marburg DNA vaccine clinical trial, in collaboration with the U.S. Military HIV Research Program, being conducted by Makerere University Walter Reed Program in Kampala, Uganda. In addition to conducting vaccine clinical trials, Dr. Ledgerwood’s research interests include the development of optimal methods to detect acute B-cell responses and neutralizing antibody induced by emerging infectious disease vaccines in clinical trials participants, to include assays for respiratory syncytial virus (RSV), severe acute respiratory syndrome (SARS), influenza, and West Nile virus.
After completing a residency in internal medicine at Johns Hopkins Bayview Medical Center in Baltimore, Maryland, in 2002, Dr. Ledgerwood joined NIAID as a clinical fellow in allergy and immunology. In 2003, she joined the Viral Pathogenesis Laboratory and Clinical Trials Core at the VRC, where she served as a clinical investigator and also conducted basic research studying a RSV mouse model of antigen presentation. Dr. Ledgerwood is board certified in allergy and immunology by the American Board of Allergy and Immunology and board certified in internal medicine by the American Board of Internal Medicine. She is a 1998 graduate of Oklahoma State University Center for Health Sciences, College of Osteopathic Medicine.
Ledgerwood JE. AS03-adjuvanted influenza vaccine in elderly people. Lancet Infect Dis 2013 Mar 18.
Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 306 Study Team. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Lancet Infect Dis. 2011 Dec;11(12):916-24. Epub 2011 Oct 3.
Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; the VRC 303 Study Team. A West Nile Virus DNA Vaccine Utilizing a Modified Promoter Induces Neutralizing Antibody in Younger and Older Healthy Adults in a Phase I Clinical Trial. J Infect Dis. 2011 May;203(10):1396-1404. Epub 2011 Mar 11.
Nabel GJ, Wei CJ, Ledgerwood JE. Vaccinate for the next H2N2 pandemic now. Nature. 2011 Mar 10;471(7337):157-8.
Ledgerwood JE, Costner P, Desai N, Holman L, Enama ME, Yamshchikov G, Mulangu S, Hu Z, Andrews CA, Sheets RA, Koup RA, Roederer M, Bailer R, Mascola JR, Pau MG, Sullivan NJ, Goudsmit J, Nabel GJ, Graham BS; VRC 205 Study Team. A replication defective recombinant Ad5 vaccine expressing Ebola virus GP is safe and immunogenic in healthy adults. Vaccine. 2010 Dec 16;29(2):304-13.
Chen M, Chang JS, Nason M, Rangel D, Gall JG, Graham BS, Ledgerwood JE. A flow cytometry-based assay to assess RSV-specific neutralizing antibody is reproducible, efficient and accurate. J Immunol Methods. 2010 Oct 31;362(1-2):180-4.
Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, Larkin BD, Enama ME, Ledgerwood JE, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 009 Study Team; VRC 010 Study Team. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS One. 2010 Feb 2;5(2):e9015.
Ledgerwood (Martin) JE, Peirson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, Andrews CA, Xu Q, Davis B, Nason M, Fay M, Koup RA, Roederer M, Bailer RT, Gomez PL, Mascola JR, Chang GJ, Nabel GJ, Graham BS. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults in a phase I clinical trial. J Infect Dis. 2007; 196:1732-1740.
Ledgerwood (Martin) JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, Bailer RT, Chakrabarti BK, Bailey MA, Gomez PL, Andrews CA, Moodie Z, Gu L, Stein JA, Nabel GJ, Graham BS and the VRC 204 Study Team. A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clinical and Vaccine Immunology. 2006; 13:1267-1277. Epub 2006 Sep 20.
Clinical Operations Manager
Ingelise Gordon, RN, has been at the National Institutes of Health (NIH) since 1991. She joined the VRC in July 2002 as a Research Nurse/Study Coordinator and now manages the clinical team of research nurses and administration staff for VRC clinical trials for preventive HIV vaccines and vaccines for emerging and re-emerging infectious diseases.
She has supported NIAID in many capacities and has worked in many of their patient care units (inpatient, outpatient, and Day Hospital nursing units). As a Case Manager for HIV protocols in two different HIV clinics within NIAID, she demonstrated her well-known skill in combination with her compassionate, thorough approach to patient care. Mrs. Gordon worked in a dual role as both the Clinic Coordinator for NIAID's Outpatient 11 clinic, while also serving as a Case Manager for NIAID's HIV primary care clinic. Mrs. Gordon had a caseload of HIV-infected, uninsured patients who lived within 50 miles of the NIH campus, and displayed her deep satisfaction in working with these individuals while showing great empathy to her patients. The problems wrought by HIV are abundantly familiar to her.
When asked why she chose to join the VRC, Mrs. Gordon stated, "Something needs to be done soon to prevent HIV altogether. I think I am fortunate to be a part of an organization that will be instrumental in finding effective prevention against HIV. I want to give something to my daughter, and the other children of the world for that matter, so that they have good things to look forward to. I want to be able to say to my grandchildren, 'Once a upon a time, a very, very long time ago, there was a deadly disease called AIDS.' "
Protocol Operation Manager
Mary E. Enama is the Protocol Operations Manager for the VRC. She joined the VRC Clinical Trials Core (CTC) in January 2002. Her responsibilities include protocol development and related project management to ensure timely scientific and regulatory reviews; protocol-specific data collection plans; and clinical trial outcomes reporting to regulatory agencies. Ms. Enama notes that, “Each clinical trial requires a well-coordinated team effort that includes laboratory scientists, clinicians, statisticians, pharmacists, regulatory and vaccine production staff. Working at the VRC is a uniquely rewarding opportunity to support the evaluation of novel vaccine approaches to HIV, filoviruses, influenza, and other viral pathogens.”
Ms. Enama was educated first as a field biologist/laboratory scientist at Franklin and Marshall College (B.A.) and Washington University in St. Louis (M.A.) and later as a Physician Assistant at Medical College of Georgia (B.S). She previously worked as a clinician in Family Practice and Pediatric Nephrology and as a Clinical Trials Specialist in a contract research organization.
Strategic Advisor for Special Projects
Brenda Larkin, RN, BSN, CCRC, joined the VRC in February 2002. Ms. Larkin previously managed the clinical team of research nurses and recruiters for the VRC clinical trials for preventive HIV vaccines and vaccines for emerging and re-emerging infectious diseases. Her previous experience was with the Johns Hopkins University, Center for Immunization Research, where she coordinated Phase I, II, and III preventive HIV Vaccine Trials since 1997. Ms. Larkin was instrumental in developing the infrastructure upon which the VaxGen study of AIDSVAXTM was conducted, receiving accolades due to its premier status among sites worldwide.
Being on the preventive end of HIV is important to Ms. Larkin, after years of witnessing the ravages of HIV/AIDS while caring for adults, especially pregnant women, in an economically depressed area 40 miles north of Boston, Massachusetts. In a community health center in Lawrence, Massachusetts, Ms. Larkin was responsible for the medical care of HIV+ men, women, and women during pregnancy. She was also the nurse coordinator for the Massachusetts Care and Advocacy Program (MassCap) in the Northeast region. The MassCap Program was initiated after the 076 study showed the benefits of AZT in pregnancy. In her role as the MassCap Nurse for the Northeastern part of Massachusetts, she was responsible for HIV training and education of providers in the area. Ms. Larkin is a Certified Clinical Research Coordinator through the Association of Clinical Research Professionals.
Knowing the great success vaccines have had in decreasing morbidity and mortality from other deadly diseases, Ms. Larkin is hopeful that, within the VRC in collaboration with concerned communities, “we will together find a way to stop the disproportionate destruction caused by HIV/AIDS."
Community Outreach and Recruitment Specialist
Nina Berkowitz joined the VRC Clinical Trials Core in 2008 to serve as a Community Outreach and Recruitment Specialist. In this role, she serves as a primary point of contact for potential volunteers. She implements volunteer recruitment strategies and outreach efforts that increase awareness of the VRC clinical research program throughout the Washington metro area.
Ms. Berkowitz prior experience involves direct community health education, in-clinic support group management, and research concerning global healthcare infrastructure and health disparities. The world of medicine has always captivated her, particularly clinical research, its evolution and its prominent contributions to health care. Ms. Berkowitz completed her undergraduate education at Virginia Tech in 2007 with a B.S. in Biology, and minors in both Spanish and Medicine and Society.
Leejah Chang, M.D., is a third-year allergy and immunology fellow at NIH, board certified in Internal Medicine (2010), and Allergy and Immunology (2012).
His interest in research began in high school when he was selected as a Waksman Student Scholar at Rutgers University performing research on the onion genome. In college, he worked in Schering-Plough's Drug Discovery Department. In medical school, he worked with Northwestern's Chief of Hepatology on a mouse model of bile salt transport. Most recently, in 2009, he worked on a novel peanut fusion protein model to prevent peanut anaphylaxis in the Division of Allergy and Immunology.
Leejah completed his internal medicine residency at McGaw Northwestern Hospital in Chicago, Illinois, in 2010. He graduated from Feinberg Northwestern Medical School in 2007. At graduation, he was awarded the Frederick Stenn Award for Humanism and Compassion in Medicine given each year to the graduating senior in the medical class who most exemplified compassion in the practice of medicine.
Research Nurse/Study Coordinator
Pam Costner, RN, BSN, CDE, joined the VRC team as a Research Nurse/Study Coordinator in 2006. She has served as a nurse in many capacities since 1987. She was an HIV counselor/educator in the late 1980s in Florida and for most of her career has operated in the public health system. Her work with the HIV positive population in a large public hospital in Seattle, Washington, was what led to Mrs. Costner's initial position at NIH in 2001 with the kidney transplant nursing unit. "They were starting a protocol to perform kidney transplants in people who were HIV infected." From there she earned her certification in diabetes education and served as a protocol coordinator for 2 years with the National Institute Diabetes and Digestive and Kidney Disease. This experience as a study coordinator and her past work with HIV populations converged in her position at the VRC.
When asked why she enjoys working at the VRC she stated, "I feel like all the work we do here at the VRC contributes to the general welfare of the world—the entire world. I want to teach my daughter to be a world citizen and community member and help make it a healthier and safer place for her and her generation. This is a place I can make a difference."
Cynthia Starr Hendel, CRNP, serves as Nurse Practitioner for the VRC clinic. Ms. Hendel joined the VRC after working in Phase I/II clinical trials with HIV preventive vaccines for more than 5 years at the Institute of Human Virology, University of Maryland, Baltimore. In her tenure with the Institute of Human Virology, Ms. Hendel served as nurse practitioner and clinic coordinator for the onsite HIV Vaccine Trials Network unit.
She is thrilled to be at the VRC where preventive and therapeutic HIV vaccines as well as other emerging disease vaccines are being developed. Her career in nursing has always emphasized health promotion and disease prevention, and her role at the VRC brings together all of her favorite aspects of nursing, health education, and clinical research. Personal health care philosophy? "The best therapy is prevention of the problem."
LaSonji Holman, RN, MSN, FNP, is a nurse practitioner for the VRC. Mrs. Holman developed a passion for preventive medicine early in her career. She is now devoted to the quest to eliminate the rampant spread of HIV and the devastating consequences of AIDS. Most recently, she worked as the senior nurse practitioner for Children's Hospital's Employee Health Clinic in Washington, D.C., where she diligently provided health education, risk reduction, and primary health screening for the hospital's employees and volunteers. Formerly, Mrs. Holman worked for Johns Hopkins University Center for Immunization Research as a practitioner for Phase I, II, and III HIV vaccine clinical trials.
Upon joining the VRC, Mrs. Holman expressed, "Prevention is the key to eradicating HIV, and I am proud to be a part of it."
Senior Nurse Practitioner
Sarah Hubka, RN, MSN, NP, is a senior Nurse Practitioner who has joined the VRC from Boston. Ms. Hubka managed Phase II, III, and IV HIV clinical research trials for the Community Research Initiative of New England, a small, non-profit research organization. While there, she successfully facilitated the testing a new class of investigational, injectable HIV medications known as fusion inhibitors. For the past 3 years, Ms. Hubka has worked exclusively in nursing research, and has been responsible for all levels of conducting complex HIV clinical trials. This focused experience is sure to enhance the work of the Clinical Trials Core of the VRC.
Ms. Hubka has cared for long-term, infected HIV-positive adults, and so, has seen the devastation wrought by HIV and AIDS. Recognizing this experience as what drives her VRC colleagues, Ms. Hubka is thrilled to be working with a team of people who she identifies as committed toward prevention, and ultimately, the eradication of HIV. When asked about her decision to join the VRC, Ms. Hubka states, "I feel like I have found my niche in this phenomenally dedicated group. I am proud to be part of an endeavor likely to provide the world with the hope of a tangible solution to effectively prevent HIV. I look forward to the challenges ahead of us."
Floreliz Mendoza, RN, joined the VRC in May 2009 as a Research Nurse. She began working at NIH as a Clinical Research Nurse in 2001 in the Solid Organ/Tissue Transplant Unit until 2004. She then served as a Float Pool Nurse at NIH where she managed patients with diverse illnesses. Mrs. Mendoza is excited to be part of the vaccine research effort and enjoys the opportunity to support VRC clinical trials.
Laura Novik, RN, BSN, MA, has joined the VRC as a Research Nurse/Study Coordinator. Ms. Novik began working as a Research Nurse at NIH in 2000 at the National Cancer Institute/ National Naval Medical Center, where she coordinated Phase II prostate cancer vaccine trials. Prior to that, she spent 18 years in nephrology nursing working in varying roles as a primary care nurse, quality management coordinator, and administrator. Beginning in the early 1980's, Ms. Novik was involved with HIV and AIDS in the clinical setting and after experiencing an HIV-related, personal loss, felt a growing need to contribute in a more meaningful way.
Upon arrival at the VRC in January 2003, Ms. Novik stated, "I feel privileged to be a part of this amazing group of dedicated staff and volunteers. I realize that a great deal of time and effort is needed to produce a serious vaccine, but I am confident that it will happen, and that it will happen here." Ms. Novik's clinical trials management experience enhances the skills of the VRC Clinical Trials Core.
Uzma Sarwar, M.D. joined the VRC as a clinical fellow. She is currently a second-year Infectious Disease fellow at NIH. Dr. Sarwar completed her first year of fellowship training at New York Presbyterian-Columbia University Medical Center. Her role at the VRC clinic is to serve as staff physician and associate investigator in Phase I and II vaccine trials. In addition to serving as associate investigator her research interests are innate and adaptive immunity post vaccination.
She completed her residency in internal medicine at New York University School of Medicine in 2009. She joined the VRC as clinic physician in 2009-2010. Dr Sarwar is board certified in Internal Medicine by the American Board of Internal Medicine. She graduated from State University of New York at Stony Brook in 2006.
Jamie Saunders, RN, BSN, joined the VRC in 2009 as a Research Nurse. She started working with HIV/AIDS patients as a nursing student at Louisiana State University Health Sciences Center in New Orleans. During her clinical rotations, she was able to see first hand how poverty, poor health education, and the lack of community resources devasted the lives of young men and women in the area. Before joining the VRC, Ms. Saunders worked at a clinic providing women's health services, which included counseling and education about HIV.
Director of Communications and Public Affairs
Sandra Sitar, MS, serves as the Director of Communications and Public Affairs for the Vaccine Research Center Clinical Trials Core. In this role, Ms. Sitar serves as the primary liaison with external constituencies to represent and communicate the mission and message of the VRC/CTC. Ms. Sitar develops content for external and internal communications including online and print materials, as well as public education and promotional materials. She joined the Vaccine Research Center as a Community Outreach and Recruitment Specialist in 2005. She continues to coordinate the development and implementation of volunteer recruitment strategies and outreach efforts to increase awareness of the VRC clinical research program. Ms. Sitar also identifies opportunities for collaboration with local and national groups and manages partnerships with area universities, faith-based organizations, and other healthcare affiliates.
Ms. Sitar's prior experience involves developing marketing strategy for international development initiatives, producing public health education and intervention campaigns, grant and proposal writing for both community-based and international organizations, as well as lesson plan design and implementation for high school and university level courses. Ms. Sitar holds an MSc from the London School of Economics and a BA from the University of California Berkeley.
Brandon G. Wilson joined the VRC Clinical Trials Core in 2009 as a Community Outreach and Recruitment Specialist. In this role, Mr. Wilson serves as a primary point of contact for potential volunteers. He implements volunteer recruitment strategies that increase awareness of the VRC clinical research program throughout the Washington metro area.
Mr. Wilson received his Bachelors in Social Work, with a minor in International Community Development from Oral Roberts University in 2002 and later studied Public Administration at the Nelson Mandela Graduate School of Public Policy. He has previously served as an HIV/AIDS Outreach Coordinator, Case Manager, Health Educator, Project Manager, and Evaluation Specialist for community-based organizations, national organizations, and bio-pharmaceutical marketing firms. He has lead projects in leading blockbuster therapies for hepatitis C virus, fetal cell research, and cervical cancer. He has also served on various non-profit Boards, Ryan White HIV/AIDS Planning Councils, and various state HIV/AIDS Community Planning Groups.
Mr. Wilson has conducted bio-psychosocial research on under-represented populations and those most affected by the pandemic; his research findings have been presented at local, regional, national, and international meetings on public health and HIV/AIDS.
The VRC Clinical Trials Core welcomed Galina Yamshchikov, MS, as a Protocol Specialist in 2009. Galina earned two Master of Science degrees: one in Biochemistry from the Moscow State University (MSU) in Russia and one in Clinical Investigation from the University of Virginia in Charlottesville. She gained valuable regulatory experience during her research fellowship at the Food and Drug Administration (CBER). Ms. Yamshchikov has significant scientific expertise in clinical research, immunology, and in immune monitoring for clinical studies in the therapeutic areas of infectious diseases, allergy, and oncology. During her time at Emory University and at the University of Virginia, she was involved in scientific projects that included assay development and validation for clinical studies.
Ms. Yamshchikov is a co-author of more than 20 scientific publications, including work on DNA vaccines. In her most recent Clinical Trials Manager position at the Clinical Research Organization United Biosource Corporation, she managed clinical trials for the pharmaceutical industry, with projects ranging from the early development Phase I studies to post-marketing Phase IV studies.
Kathryn Zephir, RN, BSN, joined the VRC in 2008 as a Research Nurse. Ms. Zephir has worked as a nurse with HIV-infected patients at the Johns Hopkins Bayview Medical Center and has seen the effects of the disease. It was during her education at Johns Hopkins School of Nursing that she became interested in clinical research. Ms. Zephir states that, “I am thrilled to be a part of something here at the VRC that has the potential to have great impact on the lives of others. I feel that I can make a difference here and am privileged to be a part of that process”.
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Last Updated October 04, 2012