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Purpose

This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women 16 to 35 years of age. Participants will receive 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 will be followed to approximately Month 36. The primary hypothesis of the study is that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.

Condition

Eligibility

Eligible Ages
Between 16 Years and 35 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy based on medical history and physical examination
  • Serologically confirmed to be CMV seronegative
  • Have direct exposure to young children (≤5 years of age) at home or occupationally
  • Of child bearing 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 history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
  • 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
V160 3-Dose Regimen 		Participants will receive V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
  • Biological: V160
    V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA)
Experimental
V160 2-Dose Regimen 		Participants will receive V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
  • Biological: V160
    V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA)
  • Drug: Placebo
    Saline solution administered as a 0.5 mL IM injection
Placebo Comparator
Placebo 		Participants will receive placebo by IM injection on Day 1, Month 3, and Month 6.
  • Drug: Placebo
    Saline solution administered as a 0.5 mL IM injection

Recruiting Locations

University of Texas Medical Branch at Galveston ( Site 0049)
Galveston, Texas 77555-1115
Contact:
Study Coordinator
409-772-5278

More Details

NCT ID
NCT03486834
Status
Recruiting
Sponsor
Merck Sharp & Dohme Corp.

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.