A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients

Inclusion Criteria:

- Participant is scheduled to receive a primary or secondary renal allograft from a
donor

- Participant is seronegative for CMV and is receiving an allograft from a
CMV-seropositive donor

- Female participants of child-bearing age must have a negative pregnancy test result
on Day 1, prior to infusion

- For women who are not postmenopausal or surgically sterile (defined as absence of
ovaries and/or uterus): agreement to remain completely abstinent or use two methods
of contraception at all times

Exclusion Criteria:

- Participant is suspected of having CMV disease

- Participant has received anti-CMV therapy within the 30 days prior to screening
(exceptions are the use of acyclovir, valacyclovir, or famciclovir for up to 10 days
duration for treatment of acute herpes simplex or herpes zoster or participants
receiving acyclovir or valacyclovir at doses to suppress herpes zoster)

- Participants who have received intravenous immunoglobulin (IVIG) within 3 months
before transplantation or with expectation of receiving IVIG at time of
transplantation or in the 3 months after transplantation

- Participants who have received B cell-depleting therapies (including but not limited
to rituximab) within 3 months before transplantation or with the expectation of
receiving such therapy at the time of transplantation or in the 3 months after
transplantation

- Participant is receiving a multi-organ transplant (e.g., liver or pancreas in
addition to kidney)

- Active or chronic hepatic or hepatobiliary disease (including known Gilbert's
syndrome) or elevations in a hepatic transaminase or bilirubin >= 2 times upper
limits of normal (ULN)

- Participant is unlikely or unwilling to be available for follow-up for the full
24-week duration of the study

- Female participants who are pregnant, plan to become pregnant during the study, or
who are breastfeeding

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins or human-derived immunoglobulin
preparations; or any constituent of MCMV5322A/MCMV3068A or placebo

- Active treatment for untreated tuberculosis or other infectious conditions that are
significant in the judgment of the investigator

- Infection with hepatitis B, hepatitis C or human immunodeficiency virus

- Previous exposure to any investigational agent within 12 weeks or 5 half-lives

- Any other acute or chronic condition, metabolic dysfunction, physical examination
finding, or clinical laboratory finding giving reasonable suspicion of a disease or
condition that, in the opinion of the Principal Investigator, contraindicates the use
of an investigational drug or that may affect the interpretation of the results or
that renders the participant at high risk for treatment complications

- History of alcoholism or substance abuse within 6 months before screening

- Participant is expected to require treatment or prophylaxis with an antiviral with
anti-CMV activity during the study