V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Condition: Cytomegalovirus (CMV) Infections
MeSH terms: Cytomegalovirus Infections
Intervention: V160; Placebo
Intervention description: V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) IM injection.; Saline solution administered as a 0.5 mL IM injection
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2200.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention of cytomegalovirus infection (CMVi)

Summary:

      This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV)
      vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to
      35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose
      regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on
      Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary
      hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the
      incidence of primary CMV infection compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy based on medical history and physical examination.

          -  Serologically confirmed to be CMV seronegative prior to receiving the first dose of
             V160/placebo

          -  Have direct exposure to young children (≤5 years of age) at home or occupationally

          -  Of childbearing potential

          -  Agrees to avoid becoming pregnant during the 6-month treatment period and for at least
             4 weeks after the last dose of study drug by either 1) practicing abstinence from
             heterosexual activity, or 2) use a highly-effective method of birth control (as
             specified in the protocol) during heterosexual activity.

        Exclusion Criteria:

          -  Has a history or current evidence of any condition, therapy, laboratory abnormality or
             other circumstance that might expose the participant to risk by participating in the
             trial, confound the results of the trial, or interfere with participation for the full
             duration of the trial, as assessed by the investigator

          -  Has history of allergic reaction or anaphylactic reaction to any vaccine component
             that required medical intervention or of any severe allergic reaction to any vaccine
             component that required medical intervention.

          -  Has a recent (<72 hours) history of febrile illness (temperature ≥100.4°F/38.0°C, oral
             equivalent)

          -  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 pose more than minimal
             risk for the participant.

          -  A woman of childbearing potential (WOCBP) who has a positive pregnancy test at
             screening or within 24 hours before the first dose of study treatment.

          -  Has previously received a 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 any dose of trial vaccine.

          -  Had any inactivated vaccine administered or scheduled within the period from 14 days
             prior to, through 14 days following, any dose of trial vaccine.

          -  Had administration of any immune globulin or blood product within 90 days prior to
             injection with V160/placebo or scheduled within 30 days thereafter.

          -  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 trial entry.

          -  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 trial).

          -  Received any anti-viral agent with proven or potential activity against CMV two weeks
             prior to vaccination or is likely to receive such an agent within 2 weeks after
             vaccination.

          -  Receiving or has received in the year prior to enrollment immunosuppressive therapies
             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 2 weeks prior to, or 2 weeks following a V160
             dose.

          -  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.

          -  Plans donation of eggs at any time from signing the informed consent through 1 month
             after receiving the last dose of the trial V160/placebo.