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

This is an interventional prevention trial for Cytomegalovirus Infections Read More

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 human immunodeficiency virus acquired immunodeficiency syndrome (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