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!
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
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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).
Help Us Recruit!
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