Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: V160; Placebo
Intervention description: V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA); Saline solution (0.9% sodium chloride [NaCl] administered as a 0.5 mL IM injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: Male
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160
      administered by intramuscular (IM) injection in healthy Japanese male participants by
      cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy based on medical history and physical examination

          -  Serologically confirmed to be CMV seropositive or CMV seronegative at Visit 1

          -  If of reproductive potential, agrees to the following from randomization through at
             least 4 weeks after the last dose of V160-/placebo (from Day 1 through Month 7): 1)
             practice abstinence from heterosexual activity and remain abstinent, or 2) use
             contraception unless confirmed to be azoospermic as detailed in the protocol

        Exclusion Criteria:

          -  History of any allergic reaction or anaphylactic reaction to any vaccine component
             that required medical intervention

          -  Plans donation of sperm any time from signing the informed consent through 1 month
             after receiving the last dose of study drug

          -  Is currently immunocompromised or has been diagnosed as having a congenital or
             acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma,
             leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid
             arthritis, inflammatory bowel disease, or other autoimmune condition that requires
             immunosuppressive medication.

          -  Has a condition in which repeated venipuncture or injections post more than minimal
             risk for the participant, such as hemophilia, thrombocytopenia, other severe
             coagulation disorders, or significantly impaired venous access

          -  Has major psychiatric illness including: any history or schizophrenia or severe
             psychosis, bipolar disorder requiring therapy, or suicidal ideation within 3 years.

          -  Has previously received any CMV vaccine

          -  Had any live virus vaccine administered or scheduled to be administered in the period
             from 4 weeks prior to, and 4 weeks following receipt of study drug

          -  Had any inactivated vaccine administered or scheduled within the period from 14 days
             prior to, through 14 days following study drug

          -  Had administration of any immune globulin or blood product within 90 days prior to
             injection with study drug or scheduled within 30 days thereafter

          -  Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of
             prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has
             not completed treatment at least 30 days prior to study entry

          -  Has received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d
             prednisone equivalent) within 14 days prior to the first vaccination (participants
             using inhaled, nasal, or topical steroids are considered eligible for the study)

          -  Has received any anti-viral agent (e.g. letermovir, ganciclovir, valganciclovir,
             foscarnet, and valacyclovir) with proven or potential activity against CMV 14 days
             prior to vaccination or is likely to receive such an agent within 14 days after
             vaccination

               -  Receiving or has received in the year prior to enrollment immunosuppressive
                  therapies including but not limited to rapamycin (also sirolimus), tacrolimus
                  (also FK-506), or other therapies used for solid organ/cell transplant, radiation
                  therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other
                  immunosuppressive therapies known to interfere with the immune response. Topical
                  tacrolimus is allowed provided that it is not used within 14 days prior to, or 14
                  days following study drug

          -  Has participated in another clinical trial in the past 4 weeks, or plans to
             participate in a treatment-based trial or a trial in which an invasive procedure is to
             be performed while enrolled in this trial.