Status:
COMPLETED
V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cytomegalovirus (CMV) Infections
Eligibility:
FEMALE
16-35 years
Phase:
PHASE2
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT03486834
Start Date
April 30 2018
End Date
June 30 2021
Last Update
January 23 2024
Active Locations (95)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Clinical Therapeutics ( Site 0025)
Birmingham, Alabama, United States, 35205
2
Achieve Clinical Research, LLC ( Site 0055)
Birmingham, Alabama, United States, 35216
3
Synexus US Phoenix Southeast ( Site 0057)
Chandler, Arizona, United States, 85224
4
Inland Empire Liver Foundation ( Site 0026)
Rialto, California, United States, 92377