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

This is a randomized, placebo-controlled, phase 2 study is to assess the safety,
reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving
a kidney transplant from a CMV-Seropositive living donor. The intent of the study is to
administer three doses of the study drug (HB-101 or placebo) prior to transplantation and
within proximity to the time of transplantation. However, two doses of study drug will be
sufficient for the patients to be included in the efficacy analyses if a third dose of study
drug is not feasible due to transplantation timelines. Patients will not receive study drug
after transplantation. Patients will be recruited globally from transplant centers. The total
duration of the study of each patient participating in the study will be approximately 15
months.

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.