Our mission is to move one step closer to the development of a cure or preventive approach for certain infectious diseases, such as Human Immunodeficiency Virus (HIV), Zika Virus and COVID-19. Our goal is to inspire and incorporate volunteers from every race, ethnicity, and gender background to join us in this mission. Together, we can move forward with these exciting developments!
The Clinical Trials Unit (CTU) is a research group within the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.
- Williams College, Williamstown, MA, B.A., 1996 (Anthropology)
- Joseph L. Mailman School of Public Health, Columbia University, New York, NY, M.P.H., 2001
- New York University School of Medicine, New York, NY, M.D., 2005
Dr. Stephenson is a physician-scientist in the Center for Virology and Vaccine Research (CVVR) and the Division of Infectious Diseases at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts. She is also an Associate Professor of Medicine at Harvard Medical School. She has expertise in conducting phase 1 clinical trials testing novel immunologic interventions for HIV and emerging infectious diseases like SARS-CoV-2 and Zika virus. During the COVID-19 pandemic, she was the site Principal Investigator for the first-in-human trial of the Johnson & Johnson/Janssen Ad26.COV2.S COVID-19 vaccine, as well as for the Phase 3 efficacy trials of remdesivir, Novavax vaccine, and casirivimab and imdevimab monoclonal antibodies. She is currently the protocol co-chair of CoVPN 3006, the largest federally-funded study to test whether the Moderna COVID-19 vaccine can block SARS-CoV-2 transmission. This COVID-19 work complements her previous contributions in testing a mosaic Ad26-based HIV vaccine and broadly neutralizing antibodies for HIV prevention, treatment and remission. In addition, Dr. Stephenson is an outspoken advocate for increasing research equity for Black and Latinx populations in clinical trials, and is committed to ensuring access to promising medicines and vaccines for our most vulnerable communities.
Dr. Stephenson received her medical degree from New York University, and completed her internal medicine training at Columbia NY Presbyterian Hospital, followed by infectious diseases training at Mass General Brigham. She also obtained a Masters in Public Health from Columbia University where she focused on the ethics of clinical trials, isolation and quarantine.
Christian Albrecht University, M.D., PhD.Hometown: Germany
As a physician-scientist, Dr. Juelg aims to link preclinical and clinical studies to identify and test the most promising immunological strategies to prevent and treat HIV infection. He is specifically interested in evaluating passive and active immunization approaches using broadly neutralizing antibodies and novel vaccine candidates. In close collaboration with other investigators at the Ragon Institute, Dr. Juelg is conducting phase I/II clinical trials that are testing such concepts and translating findings from the lab into the clinic.
Massachusetts Institute of Technology, Cambridge, MA, B.S., 2005 (Major: Biology, Minor: Chemistry)
Harvard Medical School/ Harvard-MIT Division of Health Sciences & Technology, Boston, MA, M.D., 2011 (Medicine)Hometown: Mesa, AZ
Dr. Ai-ris Yonekura Collier is a physician-scientist specializing in high-risk pregnancy care in the Department of Obstetrics and Gynecology at BIDMC. The goal of her translational research is to characterize the maternal cellular immune phenotype in pregnancy disorders like preeclampsia and fetal growth restriction and in the setting of infectious disease like Zika virus or SARS-CoV-2. During the COVID-19 pandemic, she was Principal Investigator leading the hospital-wide COVID-19 Biorepository and a co-investigator for the Ad26.COV2.S COVID-19 vaccine booster trial. This work builds upon prior work performing longitudinal observational studies in pregnant individuals exposed or infected with Zika virus and creating large clinical biospecimen repositories for translational immunologic studies in pregnancy. In addition to the work in the CTU, she is an enthusiastic educator and advocate for inclusion of pregnant and lactating individuals in observational and interventional clinical trials.
Dr. Collier obtained her M.D. through the Harvard-MIT Program in Health Sciences and Technology at Harvard Medical School where she spent time in the lab of Dr. Shannon Turley, evaluating a novel mechanism of cellular immune tolerance induction by lymph node stroma cells. She is using her background in immune tolerance to study the mechanisms of maternal immune tolerance to the fetus in placenta in healthy and complicated pregnancies. As a Maternal-Fetal Medicine clinician, she represents a cross-disciplinary collaboration between the Department of Obstetrics and Gynecology and the CVVR.
Maura Galligan Crowther RN, MSN, FNP-C
Boston College, BSN
University of Massachusetts Boston, MSN-FNPHometown: Salem, MA | Pronouns: She/her/hers
Maura is a Clinical Research Nurse Practitioner who joined the CVVR in 2022. Her interest in infectious disease, disease prevention, and global health issues is what drew her to the CVVR and she is thrilled to be part of a team dedicated to advancing research and making positive impacts in these areas. Maura graduated with her Bachelor’s in Nursing from Boston College in 1998 and her Master’s in Nursing from UMass Boston in 2006. She began her BIDMC nursing career as an RN in the Obstetrics Department and also worked in the medical center’s Post-Acute Care Transitions program. As a Nurse Practitioner, she worked for several years providing primary care at North Shore Community Health and then went on to work in College Health. Just prior to joining the CVVR, she was the Clinical Lead for the Ambulatory COVID testing site here at BIDMC. She is a proud mom to her son and, in her free time, she enjoys being outdoors and traveling near and far with her family.
Valerie Haines, RN, MSN, WHNP-BC
University of New Hampshire, BSN
Boston College, MSN
Valerie is a Clinical Research Nurse Practitioner and joined the CVVR in 2022. After graduating with her BSN from UNH, Valerie was a staff nurse at Franciscan Children’s Hospital as well as Boston Children’s Hospital in their Emergency Department. She then went back to school, earning her MSN from Boston College and became a Women’s Health Nurse Practitioner. She joined the staff at Wellesley College Health Services where she also trained. She enjoys the outdoors, playing soccer, knitting, and spending time with her family.
Esther Apraku Bondzie, MSN
Boston College, DNP candidate
Boston College, MSN
Notre Dame of Maryland University, B.A. in Biology and a minor in Classical StudiesHometown: Accra, Ghana | Pronouns: She/her/hers
Esther A Bondzie graduated from Boston College with her MSN’21. In October 2021, she joined the Clinical Trials Unit as a Research Coordinator and now works as a Clinical Research Nurse Coordinator. Esther has a great interest in infectious diseases and women’s health with a particular focus on public health. She enjoys her work and looks forward to the amazing findings that come out of the ground breaking work her group does. Esther loves spending time with her nephew and nieces and in her free time, she enjoys afro beat music, listens to an audiobook or watches a documentary.
Lydia Gallup, BSN, RN
University of Connecticut, BSNHometown: Londonderry, NH | Pronouns: She/her/hers
Lydia is a Clinical Research Nurse within the CVVR. She received her undergraduate nursing degree from the University of Connecticut in 2018. She went on to work as a Cardiac Nurse in Manchester, NH and then moved to Boston, where she has worked at BIDMC since 2019. Improving healthcare has always been a focus of Lydia’s while being an inpatient nurse. Research nursing has been the perfect opportunity to combine clinical nursing with the ability to improve healthcare for the long-run. Lydia is currently enrolled in Northeastern University’s Master in Healthcare Informatics program. She has actively been able to apply her future degree to the Clinical Research Nurse role. Her hobbies include reading, skiing, spending time outdoors and with family.
Audrey Nathanson, BSN, RN
State University of New York at Buffalo, BSNHometown: New York City, NY
Audrey is inspired by the many patients and research volunteers she’s cared for and guided through their experience with illness and/or their participation in research trials. After graduating from the State University of New York at Buffalo’s School of Nursing, Audrey began her career at Lenox Hill Hospital in New York City. Her earliest experiences as a young nurse were caring for some of the first people presenting with signs and symptoms of a mysterious, unknown disease, variously diagnosed as Fever of Unknown Origin (FUO), CMV, Pneumocystis pneumonia or Kaposi Sarcoma. What came to be known as AIDS. After moving to Boston, Audrey worked in the Cardiac Intensive Care Unit at Beth Israel Hospital where she was exposed to the research world with the many cutting edge interventional cardiac studies (PTCA, tPA, streptokinase), that were conducted at that time. Audrey took her interest in research to the Clinical Research Center at BIDMC where as a staff nurse coordinator and later, project manager, she helped implement trials in Infectious Disease, Neurology, Endocrine, Interventional Pulmonary, Sleep Medicine, and Breast Imaging. Audrey joined Dr. Stephenson’s study team as a Clinical Research Nurse Coordinator in 2021 after working with her team during the COVID-19 pandemic on the Remdesivir and Novavax vaccine trials. Audrey enjoys collaborating with research nurses across the Harvard system and beyond, and is currently doing so as an active member in the Boston-New England Chapter of the International Association of Clinical Research Nurses serving on the Board and Advisory Board of Directors.
When Audrey isn’t working you might find her riding her bike, snorkeling, watching sunsets, reading, planning her next trip and being walked by her golden retriever, Daisy.
American University, BSc in Public Health
The London School of Hygiene and Tropical Medicine, MSc EpidemiologyHometown: Sudbury, MA | Pronouns: She/her/hers
Ariana graduated from American University in 2016 with a BSc in Public Health. As an undergraduate student, she uncovered a passion for infectious and communicable disease prevention. After spending a couple years living in Germany to learn the culture and language, she pursued her MSc in London at The London School of Hygiene and Tropical Medicine to further her passion of Epidemiology and research. Throughout her studies she was drawn to research which combined both epidemiological analyses and genomics, taking a particular interest into HIV prevention research. Her thesis was a secondary analysis of a 2005 outbreak of Dengue Fever in urban Singapore, where she conducted epidemiological and phylogenetic analyses to map the spread of the outbreak. She is planning to eventually become a Nurse Practitioner to continue her work in clinical research, and hopes to continue contributing to vaccine research. Outside of work, Ariana enjoys hiking with her dogs, traveling to experience new cultures and cuisines, and spending time with family and friends.
Emmanuel College, B.S. in NeuroscienceHometown: Accra, Ghana | Pronouns: She/her/hers
Viola received her B.S in Neuroscience from Emmanuel College (Boston) in December 2022, and joined the CVVR in January 2023 as a Clinical Research Assistant working under Dr. Stephenson. During her time in undergrad, Viola was a Community Student intern with The Family Van and a Research intern for the MGH Youth Neurology Education and Research Program. Additionally, Viola was also a Research Assistant for the Leussis Behavioral Neuroscience Lab at Emmanuel College. Viola’s experiences have widened her horizons on the importance of both lab and community-based research in the communities we serve. Viola plans to pursue a Master’s in Public Health, as well as a medical degree. In her free time, Viola enjoys spending time with her family and friends, being active and trying out new foods.
Northeastern University, B.S Behavioral NeuroscienceHometown: Myanmar (Burma) | Pronouns She/her/hers
Siang was born in Myanmar (Burma) and moved to Seattle, WA when she was ten years old. She received her B.S. in Behavioral Neuroscience at Northeastern University in 2023. During her time there, she had her Co-ops at Arbour Hospital, where she worked as a Mental Health Associate for three years. She also worked as Research Assistant in the Neuroscience Histology lab at AbbVie Inc., and as a Research Assistant at the Center for Genomic Medicine at Mass General Hospital. Siang is hoping to apply to medical school and continue her education to become a psychiatrist. She aspires to educate under-represented people of color about the importance of mental health and fight to reduce inequities in mental health care. She is excited to be a part of the CVVR and gain new skills and knowledge about vaccines, virology, and clinical research. In her free time, she loves walking around the city, exploring new foods, and spending quality time with loved ones.
Pomona College, Molecular BiologyHometown: Kadoma, Zimbabwe | Pronouns: She/her/hers
Melissa Dzinoreva is a graduate of Pomona College, in Claremont CA, where she majored in Molecular biology. She joined the BIDMC Obstetrics & Gynecology Research team as a Clinical Research Assistant and also works under Dr Collier on Center for Virology and Vaccine Research projects. In her free time, Melissa enjoys watching documentaries, listening to music and exploring different ways bananas can be used as an ingredient in preparing meals.
University of Rochester, BS in MicrobiologyHometown: Brookline, MA | Pronouns: She/her/hers
Marjorie graduated from the University of Rochester in 2021 with a B.S. in Microbiology and a minor in Epidemiology. As an undergraduate student, she volunteered in the Emergency Department and Physical Rehabilitation Department at Strong Memorial Hospital and was a pre-med mentor for younger students. She also volunteered as a teaching intern with the Harvard Medical School MedScience program, which aims to address gaps in STEM-related programming for Boston-area high school students. Additionally, Marjorie worked as a Research Assistant in the Lieberman Lab in the Program for Cellular and Molecular Medicine at Boston Children’s Hospital, where she worked on immunology- and oncology-related research. She is planning to pursue a medical degree to work on providing accessible and equitable healthcare to populations in need and focusing on innovative approaches in medical education. Outside of work, Marjorie enjoys baking cookies, watching Boston sports, and spending time with family and friends.
Colgate University, B.A. in Political ScienceHometown: Canton, NY | Pronouns: She/her/hers
Ellie graduated from Colgate University in 2021 with a B.A. in Political Science. During her time at Colgate, Ellie founded and led the Colgate Vote Project, a student-run organization focused on improving rates of student voting and civic engagement in state and national elections. While studying abroad in Geneva, Switzerland, Ellie worked as an intern at the World Young Women’s Christian Association (YWCA). At the YWCA, Ellie worked to analyze the accessibility of contraceptives and other reproductive health resources for young people in Eastern Europe. After an unexpected early end to her study abroad program in March of 2020, Ellie returned home and volunteered as a COVID-19 contact-tracer and data manager for the St. Lawrence Public Health Department. In the future, Ellie hopes to pursue an M.D. and advocate for improved access to effective and compassionate healthcare in rural areas. Prior to joining the CTU, Ellie worked as a Patient Care Technician in a general medicine floor at BIDMC. She is excited to be a part of the CVVR and further her knowledge of vaccines, virology, and clinical research. In her free time, Ellie enjoys reading, writing, and spending time with her orange tabby cat, Linguini.
MCPHS University B.S. Premedical & Health Studies, with minors in Health Psychology and Public HealthHometown: Lynn, MA | Pronouns: She/her/hers
Siline graduated from Massachusetts College of Pharmacy and Health Sciences in May of 2020 with a B.S. in Premedical and Health Studies as well as minors in Health Psychology and Public Health. During her undergraduate years, she discovered her passion in ameliorating suffering due to infectious diseases. Siline joined the CTU in hopes of being in a position that would fuel both her desire to contribute to reducing health complications as well as an outlet for her ambitions for lifelong learning. She is currently pursuing a Master of Public Health degree. In her free time, Siline enjoys reading crime-fiction novels, going to the movie theaters, spending time with her loved ones and her cat.
Meaningful community engagement is critical to the ethical practice of HIV research. Input from community members is essential to help with improvement of study designs, recruitment materials, publications plans, and overall research priorities. CAB members take important HIV/AIDS research findings and disseminate them to the greater Boston community via various communication strategies including forums and educational events. Additionally, the CAB provides input on appropriate risk reduction education and counseling methods, the establishment of referral networks for medical and support services, strategies for measuring risk behavior, and the development of approaches to inform and achieve community support for future biomedical and behavioral studies.
The CVVR CAB was founded in September 2017 and consists of community members who have an interest in the HIV/AIDS epidemic and are willing to share their thoughts and opinions with the study staff. CAB members serve as advisors to the research staff and investigators by presenting community perspective and interests. Members may include but are not limited to: persons living with HIV (PLWHIV), current and past CTU clinical trial participants, family members or friends of PLWHIV, clinicians with an interest in infectious diseases and global health, those at high risk for HIV infection, or members of community-based organizations or advocacy groups. Membership in the CAB is non-discriminating and voluntary. Upon joining, new CAB members receive a welcome packet that provides education on the purpose of the CAB and CAB member responsibilities and expectations.
The CAB meets approximately three times per year for two hours.Agenda items are discussed by the CTU team prior to each meeting and finalized by the CTU director. Agenda items may include but are not limited to: discussion of community outreach and recruitment techniques, ethical and cultural considerations in research, research design for current and/or upcoming clinical trials, and educational discussions of recent literature and trial results. CAB members also receive newsletters and email communications containing trial updates and educational resources periodically throughout the year.
The focus of the CVVR Clinical Trials Unit is early phase and first-in-human studies of novel preventive and therapeutic approaches to viral illnesses and other infections. Check out our ongoing and past trials!
What is a clinical trial?
A clinical trial is a research study that is conducted with humans. Every medication that is licensed and approved for use by the FDA starts with clinical trials.
Pre-clinical trials are research studies that are conducted in the lab with cells or animals. The CVVR participates in translational research. This means that we test some of our experimental products in-house in pre-clinical trials. If determined to be safe and successful, we move onto clinical trials where we test our products with healthy participants right here at BIDMC!
What safety measures are in place?
With all clinical trials at the CVVR, your safety is our number one priority. If you decide to participate in a clinical trial with us, you will be monitored very closely by our staff. You will be assessed by a nurse at every visit, and a doctor is always available on-call if you have any questions or concerns. We routinely monitor your vital signs, such as blood pressure and temperature, and depending on the trial, we may also check your blood work.
What would I need to do if I signed up for one of your clinical trials?
Great question! Once you complete our “pre-screening” phone call, and we tell you that you are a good candidate for a study, we will ask you to come in for a “screening visit.” A screening visit is an information session where you will have time to sit down with one of our doctors, ask questions, and discuss all of the details of the study. You will also have these details written in a document for you to read at your own pace. This document is called the informed consent form (ICF).
Once all of your questions are answered, you understand the details of the study AND you agree to participate, we will ask you to sign the ICF stating that you agree to participate. Then your research journey with us begins!
Please note that all studies are voluntary, and you can withdraw your agreement to participate at any time. No study procedures (e.g. blood work, vital signs) would be completed with you until the ICF is signed.
Why should I participate?
We love this question! This is a unique opportunity to play an active role in your own healthcare and potentially help others by contributing to research. As a research participant, you would be a key player in helping to move forward potential new therapies for the public.
Where do your studies take place?
Check out our location and directions.
Do I receive compensation for participating in a trial?
Yes! Each study has its own total compensation amount, but it will typically be about $25-$50 per visit for any travel or expenses associated with participation. Some additional procedures may provide more compensation, typically around $150-300 for each procedure.
How do vaccines work?
Vaccines help the body to develop an immune response to help protect against an infection. Vaccines work through active immunization. This means that vaccines trigger your body to make special proteins called antibodies. Antibodies recognize bacteria, viruses, and other foreign substances in the body and flag them as invaders. This helps your immune system to recognize and kill these infectious agents.
How do monoclonal antibodies work?
Monoclonal antibodies (mAbs) are a type of protein produced in a laboratory. Like vaccines, mAbs help your body to develop an immune response to an infection. Monoclonal antibodies work through passive immunization. Instead of stimulating your body to make its own antibodies, mAbs are directly infused into your body. They then circulate through your body to recognize and flag invaders.
Can I Get HIV from an HIV vaccine?
It is not possible to get HIV from an HIV vaccine or Zika Virus from a Zika vaccine! Our vaccines use parts of the virus to help your body develop an immune response; however, there is not enough of the virus to be infectious.
For example, if you saw a leaf on the ground, you would recognize that it is from a tree (such as how your body would recognize a part of a virus from a vaccine), but the leaf itself would not be able to grow into a tree.
What is VISP?
VISP stands for “Vaccine-Induced SeroPositivity.” In our clinical trials, we hope that our vaccines will stimulate your body to produce antibodies. VISP happens when this is successful. Common screening blood tests recognize the presence of a disease by measuring the antibody levels in your body. These antibody lab tests are also called “titers.” After you receive a study vaccine, you may test “false-positive” for an HIV, Zika Virus, or other disease test related to the vaccine you received. Usually, more specialized tests can be run to prove that you are not infected with the disease and that the antibodies were detected because you received the study vaccine.
For FDA approved vaccines, titer levels are typically how your doctor can check to see if you are immune/protected to a certain disease after receiving a vaccine, such as a measles or hepatitis B vaccine.
This can be confusing for your doctor (for example, if you get a routine HIV test), so it is best to inform your doctor that you are participating in a research trial. For our HIV vaccine trials, our team does offer free specialized HIV testing for all study participants. You can continue to get free HIV testing through our site for as long as you remain false-positive.
Please note that if you have positive antibodies after receiving our study vaccine(s), this does not mean you are protected from the disease. This is what we are researching! Only FDA approved vaccines have been shown to have a level of protection.
Clinical Research Center
Beth Israel Deaconess Medical Center
330 Brookline Avenue, East Campus
Feldberg Building, 8th Floor
Boston, MA, 02215
T (617) 735-4610
By T (Subway)
BIDMC is accessible using the “D” and “E” branches of the MBTA Green Line.
Take the “E” branch of the Green Line to Longwood Medical Area station. Walk west down Longwood Avenue. At the corner of Longwood Avenue and Brookline Avenue, turn right. Use the East Campus Main Entrance, located at 330 Brookline Avenue.
Take the “D” branch of the Green Line to Longwood Station. Walk south up the Chapel Street hill. Make a left onto Longwood Avenue. Continue walking down Longwood Avenue and cross over the Riverway. At the intersection of Longwood Avenue and Brookline Avenue, you will see a large brown, brick building with signs for BIDMC. Use the East Campus Main Entrance, located at 330 Brookline Avenue.
BIDMC is accessible using the 8, 19, 47, 60, 65, CT2, and CT3 bus lines.
Most bus lines stop on Brookline Avenue in front of the main hospital entrance. At the intersection of Longwood Avenue and Brookline Avenue, you will see a large brown, brick building with signs for BIDMC. Use the East Campus Main Entrance, located at 330 Brookline Avenue. For specific routes and times, it is best to visit the MBTA website.
If driving, please use 330 Brookline Avenue, Boston, Massachusetts as your destination address. There is a parking garage located at the main entrance to the hospital. Detailed driving directions are located on the BIDMC website.
Clinical research brings researchers and volunteers together with the common goal of helping others live healthier lives. Researchers need your help!
For more information or if you would like to be considered for participation in a clinical research study, please contact us and join our volunteer registry.
We are available to discuss your concerns and answer your questions about participating in our clinical trials.
- Volunteers must be 18 years of age or older
- Clinical trials and research studies are approved by Beth Israel Deaconess Medical Center
- Participation is always voluntary
Information we collect
- Contact information
- Preferred method of contact
- How you heard about the registry
- Gender identity
- HIV status
- Medical conditions
- Medications used
How we protect your information
- Information will be kept electronically on a highly secured server at BIDMC.
- Only authorized study staff members will be able to access your information.
- If there is a study you might want to participate in, your contact information will be shared with that research team in a safe and secure manner so that they can reach out to you and ask you if you’d like to participate.
Your participation in the registry is entirely voluntary. You may withdraw at any time.
- The information you provide for the registry will be kept indefinitely.
- If you decide you are no longer interested in being contacted for future studies, you may withdraw your participation at any time by either calling us at 617-735-4610 or emailing us at mailto:firstname.lastname@example.org.
- If you choose to withdraw your participation, all of your information will be removed from the registry and this will have no effect on your status as a BIDMC patient, employee, or volunteer.
Risks and benefits
- There is no direct benefit to you from being in this registry.
- Potential risks include social harms if a friend or family member perceives your involvement with the registry of virology and vaccine research as negative.
- We cannot make a guarantee against potential breaches of electronic information.
After joining the registry
- We may contact you about a study in which you may choose to participate.
- There may not be a research study for which you will be eligible.
- There may not be a study in which you are interested in participating.
- The registry might be reviewed by auditors to make sure that it meets federal and state patient safety and privacy regulations. This procedure protects people who participate in research studies. Reviewers may be members of the BIDMC Institutional Review Board or regulators from the federal Food and Drug Administrators (FDA).