Safety Tolerability and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to 35 Years of Age (V160-002)

  • STATUS
    Recruiting
  • End date
    May 14, 2021
  • participants needed
    2100
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 12 August 2019
Investigator
Toll Free Number
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Emerson Clinical Research Institute ( Site 0297) (4.6 mi away) Contact
+95 other location

Summary

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.

Details
Treatment Placebo, V160
Clinical Study IdentifierNCT03486834
SponsorMerck Sharp & Dohme Corp.
Last Modified on12 August 2019

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 16 yrs and 35 yrs?
Are you female?
Do you have Cytomegalic Inclusion Disease?
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
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