Is NCT04843852 recruiting in Baltimore, MD?

Yes, NCT04843852 is currently recruiting participants at its Baltimore, MD location. This hepatitis b clinical trial is actively enrolling qualified participants.

How do I join the hepatitis b clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hepatitis B Clinical Trial in Baltimore, MD

About This Hepatitis B Study in Baltimore

The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are: 1. Is HEPLISAV-B safe in people with chronic hepatitis B? 2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B? 3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B? Participants will: * Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections. * Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months. * Be asked if they are having any side effects from HEPLISAV-B. * Have blood samples collected.

Sponsor: University of Maryland, Baltimore

Who Can Participate

Inclusion Criteria

In order to participate in this study, an individual must meet all the following criteria:

\>18 years old

Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections

Currently receiving NUC with HBV VL \<100 IU/ml for ≥ 12 months

Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.

Determined by medical history, targeted physical examination, and clinical judgement of the investigator to be in good health. CHB infection is defined as any individual with documentation of a positive HBsAg and/or detectable HBV DNA test for at least 6 months.

Exclusion Criteria

A participant will be ineligible to participate on this study if any of the following criteria are met:

Pregnancy or breast feeding.

Received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Received anti-CD20 immunosuppressant within 12 months of screening. Topical tacrolimus is allowed if not used within 14 days prior to Day 1.

Received or plans to receive live virus vaccines within 4 weeks, and inactivated vaccine within 2 weeks prior to randomization; or plans to receive a non-study vaccine within 28 days after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine).

Administration of any blood products within 3 months prior to randomization.

Participation in a study with an investigational study product or device within 30 days of randomization.

Has allergies to any hepatitis B and/or yeast-based vaccines.

Subjects meeting any of the following laboratory parameters at screening:

ALT greater than 3 times the upper limit of normal

Elevated total bilirubin WITH direct bilirubin greater than 2 times upper limit of normal

Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as ≥ 38.0°C/100.4°F). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.

Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT04843852) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatitis B Treatment Options in Baltimore, MD

If you're searching for hepatitis b treatment options in Baltimore, MD, this clinical trial (NCT04843852) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced hepatitis b specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatitis b clinical trials near you to find additional studies recruiting in your area.

Hepatitis B Clinical Trial in Baltimore, MD

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