A Study of the Experimental Cytomegalovirus (CMV) Vaccine (HB-101) in Kidney Transplant Patients

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Age: 18 to 99 years old
Gender:
Any
Healthy Volunteers: No
Keywords: CMV, kidney transplant, Cytomegalovirus infection, Cytomegalovirus, Cytomegalovirus vaccine
Type: Biological study, Phase 2
Target:
5 Participants
Investigator:
Description
The purpose of this clinical research study is to see if an investigational anti-Cytomegalovirus (CMV) vaccine known as HB-101 is safe to use and helps patients.

The main purpose of this study is find out:
 How well HB-101 could protect from significant CMV infections.
 The side effects of HB-101.

CMV is a common infection that can be dangerous when your defense against commonly mild infections is low. For example, this can happen in patients who receive a kidney from a donor. Most people whose immune system is working well with CMV infection have no symptoms. If any, symptoms are mild illness such as fever, sore throat, fatigue, and swollen glands. However if your immune system is weak, CMV can affect your lung, gut, eye or other organs and can create severe damages.

This study involves the use of an new investigational anti-CMV vaccine known as HB-101.

HB-101 is a vaccine that is believed to prevent CMV infection after kidney transplant by forming antibodies and stimulating your immune cells against CMV.

This vaccine doesn’t contain eggs or mercury. HB-101 contains a Genetically Modified Organism (GMO). The vaccine uses genes from two different viruses, but it can’t reproduce any infectious viruses in your body. The HB-101 vaccine is constructed from parts of a LCMV. The parts of the LCMV used is not alive and cannot reproduce or give you an infection. When HB-101 vaccine is introduced inside your body, it tricks your body in thinking it has CMV. It teaches your immune system to make antibodies to protect you against CMV infection. The HB-101 vaccine is not live and can’t spread in your body or outside your body in the environment.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

Patients who meet all of the following inclusion criteria will be eligible to participate in the study: 1. Male or female patients 18 years of age or older. 2. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards. 3. Patients must be CMV immunoglobulin G (IgG) seronegative (-) and receiving kidney for transplantation from donors who are CMV IgG seropositive (+). 4. Patients who would comply with the requirements of this protocol (e.g., return for follow up visits), as judged by the investigator.

Exclusion criteria:

Patients who meet any of the following criteria will be excluded from the study: 1. Patients planning to undergo multi-organ transplantation. 2. Patients participating in another interventional clinical study. 3. Previous vaccination with an investigational CMV vaccine. 4. Any confirmed or suspected immunodeficiency disorder (based on medical history and physical examination) that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development. 5. Treatment with any chronic immunosuppressive medication or other immuno modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids and low-dose oral corticosteroids (<10 milligrams a day of prednisone or equivalent) are allowed. 6. Prior history of CMV disease or CMV infection requiring anti-viral therapy 7. Patients with a rash, dermatological condition, or tattoo in the area of the injection site(s) that could interfere with administration site reaction rating. (Note: The injection site(s) can be the non-dominant arm [most preferred injection site], dominant arm, or either thigh [least preferred injection site], as judged by the investigator). 8. It is anticipated that the patient will be unavailable to complete the study follow-up.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $135 per visit for your time and effort. Payment will be in the form of a check issued to you at the end of the study. If you decide to leave the study early, you will be compensated at a pro-rated amount of $135 per visit for you time.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for approximately 15 months. The treatment period will occur before your surgical transplant and last about 2 to 3 months. You will be monitored for 12 months after transplant.
Recruitment period
From April 26, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Katherine Howes
Research Topic
Conditions:
  • Cytomegalovirus (CMV) Infection
  • Kidney Transplantation