Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: V160 Low Dose IM; V160 Medium Dose IM; V160 High Dose IM; V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM; V160 High Dose plus MAPA 225 µg /dose IM; V160 Maximum Dose IM; Placebo IM; V160 Medium Dose ID; Placebo ID
Intervention description: V160 administered as a 0.75 mL intramuscular injection; V160 administered as a 0.75 mL intramuscular injection; V160 administered as a 0.75 mL intramuscular injection; V160 plus MAPA administered as a 0.75 mL intramuscular injection; V160 plus MAPA administered as a 0.75 mL intramuscular injection; V160 administered as a 0.75 mL intramuscular injection; Placebo administered as a 0.75 mL intramuscular injection; V160 administered as a 0.1 mL intradermal injection; Placebo administered as a 0.1 mL intradermal injection
Intervention MeSH terms: Aluminum phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety, tolerability, and immunogenicity of various doses,
      formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160
      administered in a 3-dose regimen in healthy adults. The initial treatment arm of HCMV
      seropositive participants will receive V160 Low Dose without adjuvant by intramuscular
      injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal
      injection, and vaccination of HCMV seronegative participants will be performed only after
      review of safety data of previous treatment arms. The purpose of the study is to identify
      vaccine formulations associated with optimal safety profile and HCMV-specific immune response
      for evaluation in subsequent clinical studies of V160.
    

Eligibility criteria:

        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