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) and Zika Virus. 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!

Help us bridge the gap between research and treatment.

We are always looking for healthy adults to participate in our studies. Learn how you can participate in our clinical studies and join our volunteer registry.

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.

CTU Team Jan 2020

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
Hometown: New York, NY

Dr. Stephenson is a physician-scientist who specializes in infectious diseases and HIV immunology, and the goal of her research is to develop novel biomedical interventions to prevent and treat HIV and emerging infectious diseases such as Zika virus. In particular, she is interested in the design and evaluation of HIV vaccines and monoclonal antibodies that can be effective in the face of tremendous HIV sequence diversity, as well as in the development of Zika vaccines. As an immunologist, her expertise is in the extensive epitope mapping of cellular and humoral immune responses. As a clinical investigator, her expertise is in the translation of novel vaccines and monoclonal antibodies into First-in-Human, Phase 1 clinical trials, and she is the Director of the Center for Virology and Vaccine Research Clinical Trials Unit. She is also Associate Editor of Clinical Immunology.

Boris Juelg, M.D., Ph.D.

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.

Clinical Research Nurse Coordinators

Jessica Ansel, R.N., B.S.N.

SUNY Geneseo, BA Chemistry
Stony Brook University, BSN Nursing
University of Massachusetts Boston, MSN, AGNP, May 2020

Hometown: Hauppauge, NY

Jess is a native to New York and grew up in the suburbs of Long Island. She received her BA in Chemistry from SUNY Geneseo in 2010 and her BS in Nursing from Stony Brook University in 2014. Jess developed her nursing skills working on a fast-paced medical surgical unit at a community hospital on Long Island. While she enjoyed working as a floor nurse, she ultimately knew she had an interest in a career that could combine both healthcare and research. In 2015, Jess relocated to Boston, MA to begin working as a clinical research nurse coordinator at the Center for Virology and Vaccine Research. She quickly developed a passion for the CVVR’s mission. Jess is currently enrolled in the Adult Geriatric Nurse Practitioner Program at U Mass Boston and will graduate with her MSN in May 2020. She plans to use this degree to further her healthcare and research efforts. When she’s not working hard, Jess enjoys cooking, traveling, and attending Orange Theory Fitness classes.

Kate Jaegle, R.N., B.S.N.

University of Connecticut, BSN
University of Massachusetts Boston, MSN-AGNP May 2020

Hometown: Brookfield, CT

Kate is a Clinical Research Nurse Coordinator and currently works on T003, a triple antibody infusion study. She graduated from University of Connecticut in 2012 with a BSN. During her time at UCONN she studied abroad in Cape Town, South Africa and provided care to the HIV/AIDS population which sparked her interest in her current work. From there, she has worked as a staff nurse both in Connecticut and in Boston at Spaulding Hospital in Cambridge and New England Baptist Hospital. She is currently pursuing a Master’s Degree in Nursing specializing in the Adult-Gerontologic population and will be graduating in May 2020. Her hobbies include skiing, traveling and spending time with family.

Diane Kanjilal, R.N., B.S.N.

Penn State, Bachelors in Nursing
Simmons University, Candidate, Masters of Science in Nursing, Family Nurse Practitioner
Simmons University, Candidate, Doctorate of Nursing Practice

Hometown: Montreal, Quebec Canada

Diane comes from a line of nurses that stretches back two generations. She received her BS in nursing from Penn State University in 2006. Her nursing career began at Mount Sinai Hospital in Manhattan, working in the pediatric intensive care unit for four years, followed by three years in an outpatient medicine / pediatric setting. In 2012 she took a position as a clinical research nurse coordinator (CRNC) in the Division of Pediatric Allergy and Immunology, where she gained experience in the design and execution of clinical trials. Continuing to follow her passion for research, in 2016, she moved to Boston, where she joined the CVVR CTU as a CRNC. She has the pleasure of coordinating some of the exciting clinical trials that are conducted within the CVVR, which include preventional vaccines and therapeutics for a multitude of infectious diseases, such as the Human Immunodeficiency Virus (HIV). She plans to obtain a master’s degree as a Family Nurse Practitioner, and then her doctorate in Nursing Practice so that one day she can lead her own research studies and become a leader within the nursing field. In her spare time, Diane enjoys visiting local museums, biking around Boston, and building her skills as an amateur foodie.

Clinical Research Assistants

Connor Bradshaw

Emmanuel College, B.S. in Biology

Hometown: Branford, CT

Connor received his B.S. in Biology with a concentration in Health Sciences from Emmanuel College in 2017. During this time, he was a member of the Men’s Soccer Team, served on the Academic Integrity Board, and participated in Emmanuel College’s Alternative Spring Break, where he and other students volunteered their time at various service locations throughout the Boston area. As an undergraduate, he conducted clinical research at Boston Medical Center that looked to prove a method of quantifying fibrotic tissue build-up as a result of radiation therapy in head and neck cancer patients, and to hopefully improve treatment options and quality of life outcomes for future patients in the field. In his spare time, he enjoys exercising, reading, and exploring new parts of Boston. Connor is passionate about public health and infectious disease research, and hopes to go on to graduate school to learn how to better address the health care inequities that exist in the world.

Tatenda Makoni

Hill College, A.S. in Chemistry/Physics
Gordon College, B.S. in Chemistry

Hometown: Harare, Zimbabwe

Tatenda graduated from Gordon College with a Bachelor’s of Science degree in Chemistry – Biochemistry and Health Professions concentrations in December 2017. Her last summer as an undergraduate was spent at the Nelson Mandela School of Medicine in KwaZulu – Natal, South Africa where she performed question based HIV research under the mentorship of Dr. Zaza Ndhlovu. Tatenda hopes to pursue a career in medicine, public health, and HIV research. She eventually plans on going back to her home country of Zimbabwe where she hopes to positively influence the policy making in the government health sector. During her spare time, Tatenda enjoys watching TV, going to the beach and trying out different coffee shops.

Anna Tyler

Trinity College, CT,  B.S. in Biology

Hometown: Essex, MA

Anna graduated from Trinity College in 2017 with a Bachelor of Science in biology with a concentration in biomedical sciences. At Trinity, she worked as a biology laboratory teaching assistant and has previously conducted research on Vibrio cholerae vaccines at Massachusetts General Hospital. Anna has long been interested in infectious diseases and is currently deciding between pursuing an M.P.H. in epidemiology or an M.D. to become an infectious disease specialist.

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.

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

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!

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.

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.

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.

Check out our location and directions.

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.

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.

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.

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.

More information about vaccines.

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.

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Ascent – IPCAVD012/HVTN118

This study is evaluating different vaccine regimens using experimental HIV vaccines in healthy HIV-negative adults.  The main purpose of this study is to test how safe and how well-tolerated…
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Z002

This study assessed two different dosages of an investigational Zika Virus vaccine (Ad26.ZIKV.001) in healthy adults. The main purpose was to determine if the study vaccine was safe and if any…
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IPCAVD010

This study assessed different vaccine schedules using two experimental HIV vaccines in healthy, HIV-negative adults. The study started in March 2016 and was completed in January 2019.
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Z001

This study evaluated different vaccine schedules using an investigational Zika Virus vaccine in healthy adults. The study started in October 2016 and was completed in June 2018.
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T001

This study evaluated different dosages of a monoclonal antibody given intravenously and subcutaneously in healthy HIV-negative and healthy HIV-positive adults. The study closed enrollment in…
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T002

This study evaluated different dosages of a monoclonal antibody given intravenously and subcutaneously in healthy HIV-negative and healthy HIV-positive adults. The study closed enrollment in…
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T003

This study is assessing the use of an infusion of three antibodies as an alternative treatment for people living with HIV. We want to see if these antibodies can control the virus during an…
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HTX1002

This study is assessing a therapeutic HIV vaccine as an alternative treatment for people living with HIV. We want to see if this shot can redirect your immune system to take control of the virus.…
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T003

This study is assessing the use of an infusion of three antibodies as an alternative treatment for people living with HIV. We want to see if these antibodies can control the virus during an…
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HTX1002

This study is assessing a therapeutic HIV vaccine as an alternative treatment for people living with HIV. We want to see if this shot can redirect your immune system to take control of the virus.…
/by

Ascent – IPCAVD012/HVTN118

This study is evaluating different vaccine regimens using experimental HIV vaccines in healthy HIV-negative adults.  The main purpose of this study is to test how safe and how well-tolerated…
/by

Z002

This study assessed two different dosages of an investigational Zika Virus vaccine (Ad26.ZIKV.001) in healthy adults. The main purpose was to determine if the study vaccine was safe and if any…
/by

T001

This study evaluated different dosages of a monoclonal antibody given intravenously and subcutaneously in healthy HIV-negative and healthy HIV-positive adults. The study closed enrollment in…
/by

T002

This study evaluated different dosages of a monoclonal antibody given intravenously and subcutaneously in healthy HIV-negative and healthy HIV-positive adults. The study closed enrollment in…
/by

IPCAVD010

This study assessed different vaccine schedules using two experimental HIV vaccines in healthy, HIV-negative adults. The study started in March 2016 and was completed in January 2019.
/by

Z001

This study evaluated different vaccine schedules using an investigational Zika Virus vaccine in healthy adults. The study started in October 2016 and was completed in June 2018.

Help us bridge the gap between research and treatment.

We are always looking for healthy adults to participate in our studies. Learn how you can participate in our clinical studies and join our volunteer registry.

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

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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.

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

  • 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
  • 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.
  • 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.
  • 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.
  • 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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