Clinical Trials Core Laboratory
Senior Staff
Julie E. Ledgerwood, D.O.
Deputy Chief and Principal Investigator
Julie (Martin) 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 (WNV).
After completing a residency in internal medicine at Johns Hopkins Bayview Medical Center in Baltimore 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 respiratory syncytial virus (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.
Selected Publications
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, VRC 204 Study Team. A DNA vaccine for Ebola virus is safe and immunogenic in a Phase I clinical trial. Clin Vaccine Immunol. 2006 Nov;13(11):1267-77.
Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Martin JE, McCluskey MM, Chakrabarti BK, Lamoreaux L, Andrews CA, Gomez PL, Mascola JR, Nabel GJ, VRC 004 Study Team. Phase I safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis. 2006 Dec 15;194(12):1650-60.
Martin JE, Pierson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, Andrews CA, Xu Q, Davis BS, Nason M, Fay M, Koup RA, Roederer M, Bailer RT, Gomez PL, Mascola JR, Chang GJ, Nabel GJ, Graham BS, VRC 302 Study Team. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a Phase I clinical trial. J Infect Dis. 2007 Dec 15;196(12):1732-40.
Martin JE, Louder MK, Holman LA, Gordon IJ, Enama ME, Larkin BD, Andrews CA, Vogel L, Koup RA, Roederer M, Bailer RT, Gomez PL, Nason M, Mascola JR, Nabel GJ, Graham BS, VRC 301 Study Team. A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial. Vaccine. 2008 Nov 25;26(50):6338-43.
Sullivan NJ, Martin JE, Graham BS, Nabel GJ. Correlates of protective immunity for Ebola vaccines: implications for regulatory approval by the animal rule. Nat Rev Microbiol. 2009 May;7(5):393-400.
Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vacc. 2009 Sep;5(9):923-6.
Ingelise Gordon, RN
Clinical Operations Manager
Ingelise Gordon, RN, has been at the National Institutes of Health since 1991. She joined the Vaccine Research Center in July 2002 as a Research Nurse/Study Coordinator and now manages the clinical team of research nurses and administration staff for the Vaccine Research Center's 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, Ingelise 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.' "
Brenda D. Larkin, RN, BSN, CCRC
Strategic Advisor for Special Projects
Brenda Larkin, RN, BSN, CCRC joined the Vaccine Research Center, National Institute of Allergy and Infectious Diseases at the National Institutes of Health in February of 2002. Ms. Larkin previously managed the clinical team of research nurses and recruiters for the Vaccine Research Center's clinical trials for preventive HIV vaccines and vaccines for emerging and re-emerging infectious diseases. Brenda's 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. Brenda 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. Brenda 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 Vaccine Research Center in collaboration with concerned communities, “we will together find a way to stop the disproportionate destruction caused by HIV/AIDS."
Staff
Nina Berkowitz
Community Outreach and Recruitment Specialist
Nina Berkowitz joined the Vaccine Research Center Clinical Trials Core in 2008 to serve as a Community Outreach and Recruitment Specialist. In this role, Nina 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 Nina, 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 BS in Biology, and minors in both Spanish and Medicine and Society.
Pamela Costner, RN, BSN, CDE
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 two years with the National Institute Diabetes & Digestive & Kidney Disease (NIDDK). 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."
Niraj Desai, MD
Staff Physician
Niraj Desai, MD is a staff physician for the Clinical Trials Core of the Vaccine Research Center (VRC). He is an Associate Investigator for Phase I protocols to study the safety and immunogenicity of vaccines for biodefense and emerging infectious diseases and an Associate Investigator for Phase I HIV vaccine clinical trials at the VRC.
Dr. Desai is Board Certified in Internal Medicine by the American Board of Internal Medicine. He graduated from Northeastern Ohio Universities College of Medicine in 2005 and he completed his residency in Internal Medicine at Rush University Medical Center in 2008.
Cynthia Starr Hendel, CRNP
Nurse Practitioner
Cynthia Starr Hendel, CRNP serves as Nurse Practitioner for the Vaccine Research Center clinic. Ms. Hendel joined the VRC after working in Phase I/II clinical trials with HIV preventive vaccines for more than five 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
Nurse Practitioner
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, & III HIV vaccine clinical trials.
Upon joining the VRC, LaSonji expressed, "Prevention is the key to eradicating HIV, and I am proud to be a part of it."
Sarah Hubka, RN, MSN, NP
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 three years, Sarah 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."
Diane Johnson, MPH
Director of Social Marketing
Diane Johnson, MPH is the Director of Social Marketing for the Vaccine Research Center Clinical Trials Core. She joined the VRC in 2006 as a Sr. Specialist for Community Outreach and Recruitment. In her current role, Ms. Johnson directs the social marketing initiatives for the VRC/CTC including monitoring and evaluation of volunteer recruitment data. With the Community Outreach, Education and Recruitment (COER) team, she also works to coordinate, manage, and implement activities to recruit individuals for VRC vaccine trials. Ms. Johnson collaborates with community-based organizations including universities, schools, and religious institutions and works to enhance the social marketing capacity for the Vaccine Research Center.
Ms. Johnson is a W. K. Kellogg Fellow for Emerging Leaders in Public Health, Class of 2006. She has previously worked on international HIV/AIDS issues with a local non-profit organization where she managed support to over 12 PEPFAR (President's Emergency Plan for AIDS Relief) countries in Africa and $6 million in funding. Ms. Johnson has also worked with the National Academy of Sciences, Institute of Medicine. She has written topical health articles for commissioned web sites, CD-ROMs, and continuing education credits. Ms. Johnson is a graduate of Brown University and received her MPH from the University of North Carolina Gillings School of Global Public Health.
Yesenia Merino, CCRC
Community Outreach and Recruitment Specialist
Yesenia Merino, CCRC joined the Vaccine Research Center in April 2008 as a Community Outreach and Recruitment Specialist. She is involved in both community outreach and education regarding vaccine clinical research trials as well as preliminary screening for potential volunteers.
Ms. Merino is certified as a Clinical Research Coordinator, having previously coordinated HIV and infectious disease clinical research trials. She has experience in centralized clinical trials recruitment as well as HIV case management, prevention education, and community outreach. She is a graduate of George Mason University. For her, working at the VRC is an amazing opportunity to combine both her love of the scientific aspects of HIV research and her passion for education and outreach in the community.
Laura Novik, RN, BSN, MA
Research Nurse/Study Coordinator
Laura Novik, RN, BSN, MA has joined the VRC as a Research Nurse/Study Coordinator. Ms. Novik began working as a Research Nurse at the National Institutes of Health 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 to the VRC in January of 2003, Laura 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.
Sandra Sitar, MS
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. Sandra Sitar 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 B.A. from the University of California Berkeley.
Sheryl Young, MD
Clinic Physician
Sheryl Young, MD joined the Vaccine Research Center in September 2008 as a Clinic Physician. She has a longstanding interest in public health and preventive medicine. She developed a particular interest in HIV during her educational and patient care experiences in medical school and residency. During her medical school training at the University of Pennsylvania and her internal medicine residency at Tulane University, Dr. Young witnessed first hand the consequences of HIV on individuals and in the community. She is excited to join a group that is so passionate about preventing HIV and curtailing the ensuing worldwide devastation.
Dr. Young graduated from Case Western Reserve University with a Bachelor of Arts in Biology and Sociology. She is a graduate of the University of Pennsylvania School of Medicine and the Tulane University Internal Medicine Program. Dr. Young is Board Certified in Internal medicine and continues to actively participate in patient care.
Kathy Zephir, RN, BSN
Research Nurse
Kathryn Zephir, RN, BSN, joined the Vaccine Research Center 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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