Together, we move forward
Our Mission
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!
Meet the Team
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.
Principal Investigators
Kathryn E. Stephenson, M.D., M.P.H.
- 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.
Boris Juelg, M.D., Ph.D.
Christian Albrecht University, M.D., PhD.
Hometown: GermanyAs 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.
Ai-ris Yonekura Collier, M.D.
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, AZDr. 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.
Clinical Research Nurse Practitioners
Maura Galligan Crowther RN, MSN, FNP-C
Boston College, BSN
University of Massachusetts Boston, MSN-FNP
Hometown: Salem, MA | Pronouns: She/her/hersMaura 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.
Clinical Research Nurse
Lydia Gallup, BSN, RN
University of Connecticut, BSN
Hometown: Londonderry, NH | Pronouns: She/her/hersLydia 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, BSN
Hometown: New York City, NYAudrey 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.
Clinical Research Coordinators
Ritobhas (Ricky) Bhowmik
Boston University, BA in Biology with a minor in Chemistry
Hometown: Richmond, Virginia / New Delhi, India | Pronouns he/him/hisDuring his undergraduate years, he worked as a medical assistant in the Hematology/Oncology clinic at BIDMC and volunteered as a patient experience volunteer in the Faar inpatient buildings. He regularly volunteers at the Boston Red Cross Food Pantry on the weekends and has served as the volunteer coordinator for Boston University Red Cross Volunteers since 2021. His research at Boston University Medical School focused on the molecular mechanisms of airway disorders using zebrafish and frog embryos at the Garcia-Marcos Lab. While at the Center for Regenerative Medicine, he worked as an undergraduate research assistant in the Hawkins Lab studying rare airway disorders using induced pluripotent stem cells. His career goal is to pursue a career in medicine to advance medical research and improve healthcare access for underserved populations. In his free time, he enjoys playing soccer with his friends, hosting soccer watch parties, experimenting with new recipes, and exploring new hiking trails.
Marlie Bruno
Gordon College, BA in Biology
Hometown: Medford, MA | Pronouns: She/her/hersMarlie graduated from Gordon College with a BA in Biology, and started working under Dr. Stephenson as a Clinical Research Coordinator in July 2024. Previously she worked at a Boston Public High School in Dorchester, MA teaching and substituting primarily Biology, Algebra, and Chemistry courses. She has also worked as a Laboratory Support Technician at BIDMC, and as intern on a study on opioid use disorder at MGH. Marlie hopes to one day become a practicing physician, and to also participate in closing gaps in health care disparities found both locally and internationally. Outside of work, she enjoys learning new languages and weight lifting.
Melissa Dzinovera
Pomona College, Molecular Biology
Hometown: Kadoma, Zimbabwe | Pronouns: She/her/hersMelissa 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.
Eleanor Nicholson
Pomona College, BA in Molecular Biology
Hometown: Portland, OR | Pronouns: She/her/hersEleanor graduated from Pomona College in 2024 where she captained the Varsity volleyball team and majored in Molecular Biology. As an undergraduate, Eleanor was fascinated with exploring infection diseases. She researched the positive effects that CBD has on protecting hosts from Salmonella enterica, among other enteric pathogens. Later, she worked in a malaria lab in Melbourne, Australia during her semester abroad where her project focused on localizing and characterizing a novel protein, SWEET, a bidirectional glucose transporter in Plasmodium Bergheim thought to the mechanism by which parasitism evolved Finally, for her year-long experimental thesis, she developed a high-throughput selective killing bacterial assay that tests the selectivity of new, narrow-spectrum antibiotics, including small, cyclic antimicrobial peptides (AMPs). Eleanor enjoys watching movies, and playing pickleball and beach volleyball in her free time.
Summer Interns
Rika Yahashiri
Williams College 2025 B.A. Biology conc. Biochemistry and Molecular Biology
Hometown: Iowa City, IA | Pronouns: She/her/hersRika is a rising senior at Williams College planning to graduate in the spring of 2025 with a major in Biology and concentration in Biochemistry and Molecular Biology. At Williams, Rika is a varsity swimmer on the Williams Swim and Dive team, a chemistry TA, and is planning to write a thesis with the Bowman biochemistry lab. The past summers, Rika has worked as a research assistant in the Hart lab (drug resistant mutations) at Williams College and the Petersen lab (infectious diseases) at the University of Iowa. In the future, Rika is hoping to pursue a medical degree. She is excited to learn more about clinical research this summer with the Stephenson team and CVVR. In her free time, she enjoys spending time with friends, trying new foods, and hiking.
Community Advisory Board
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.
Those interested in joining the CAB are encouraged to call (617) 735-4610 or email cvvrtrials@bidmc.harvard.edu.
CAB Newsletter Issues
- CAB Gab June 20232023-08-15 - 3:22 pm
- CAB Gab June 20222022-07-12 - 11:45 am
- CAB Gab May 20202020-05-25 - 10:18 am
CAB Gab December 20192019-12-01 - 12:59 pm
Studies
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!
Frequently Asked Questions
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.
Contact Us
Clinical Research Center
Beth Israel Deaconess Medical Center
330 Brookline Avenue, East Campus
Feldberg Building, 8th Floor
Boston, MA, 02215
T (617) 735-4610
E cvvrtrials@bidmc.harvard.edu
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.
By Bus
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.
By Car
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.
Participate!
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.
T 617-735-4610
E cvvrtrials@bidmc.harvard.edu
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
More Information
Information we collect
- Name
- Contact information
- Preferred method of contact
- How you heard about the registry
- Age
- Sex
- Gender identity
- Height
- Weight
- HIV status
- Allergies
- 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:cvvrtrials@bidmc.harvard.edu.
- 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).
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