Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

Inclusion Criteria:

- Healthy based on medical history and physical examination

- Serologically confirmed to be HCMV seronegative or HCMV seropositive

- Agrees to avoid unusual, unaccustomed strenuous, vigorous physical exercise/activity
from 72 hours before through 72 hours after each dose of study vaccine

- Body weight ≥110 lbs (50 kg) and body mass index (BMI) of 19 to 32 kg/m^2

- If of reproductive potential, agrees to the following during the study and for 4
weeks after the last dose of study vaccine: 1) practice abstinence from heterosexual
activity, or 2) use or have their partner use 2 allowable methods of birth control
during heterosexual activity

Exclusion Criteria:

- Has previously received any cytomegalovirus vaccine

- Has history of allergic reaction or anaphylactic reaction to any vaccine component
that required medical intervention

- Has history of any severe allergic reaction that required medical intervention

- Is pregnant or breastfeeding or expecting to conceive from 2 weeks before the study
through 1 month after the last dose of study vaccine

- Plans to donate eggs or sperm from study start through 1 month after the last dose of
study drug

- Has impairment of immunologic function including, but not limited to autoimmune
disease, splenectomy, or HIV/AIDS

- Received systemic corticosteroids for ≥14 consecutive days and has not completed
treatment within 30 days of study start

- Received immunosuppressive therapy including, but not limited to rapamycin and
equivalents, tacrolimus, FK-506, fujimycin, or other therapies used for solid
organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic chemotherapy,
or other therapy known to interfere with the immune response within 1 year of study
start

- Has a condition in which repeated venipuncture or injections pose more than minimal
risk, such as hemophilia, thrombocytopenia or other severe coagulation disorders, or
significantly impaired venous access

- Has a condition that requires active medical intervention or monitoring such as
diabetes mellitus, autoimmune disease, or a clinically significant chronic medical
condition that is considered progressive

- Has history within the past 5 years or current drug or alcohol abuse

- Has major psychiatric illness

- Is legally or mentally incapacitated

- Has participated in another clinical study in the past 4 weeks, or plans during the
present study to participate in a treatment-based study or a study in which an
invasive procedure is performed

- Has received valganciclovir, ganciclovir, valacyclovir, foscarnet, or cidofovir from
4 weeks prior to 1 month following each V160 vaccination