Who can participate
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
3. For Groups 1 and 2 only, patients must be CMV immunoglobulin G (IgG) seronegative (-)
and receiving kidney for transplantation from donors who are CMV IgG seropositive (+).
4. For Group 3 only, patients must be CMV immunoglobulin G (IgG) seronegative (+)
and receiving kidney for transplantation from donors who are CMV IgG seropositive (+) or
CMV IgG seronegative (-).
5. Patients who would comply with the requirements of this protocol (e.g., return for
follow up visits), as judged by the investigator.
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
6. Patients who are pregnant, breastfeeding, or planning to become pregnant during the
7. For Groups 1 or 2 only, a prior history of CMV disease or CMV infection requiring anti- viral
8. For Group 3 only, patients with active CMV infection requiring anti-viral therapy within 30
days prior to the first injection of study drug.
9. 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
10. It is anticipated that the patient will be unavailable to complete the study