EUCTR2017-004233-86-ES进行中（未招募）1 期
Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3- Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age - V160 2-Dose and 3-Dose Regimens vs. Placebo in Healthy CMV Seronegative Females
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1) Healthy, based on medical history and physical examination
- •2) Female, 16 to 35 years of age
- •3) Serologically confirmed as CMV seronegative (based on CMV IgG) prior to receiving the first dose of V160/placebo
- •4) Have direct exposure to young children (<5 years of age) at home or occupationally
- •5) Childbearing potential
- •6) Agrees to avoid becoming pregnant during the 6-month treatment phase and for 4 weeks after the last dose of V160/placebo (from Day 1 through Month 7) by either practicing abstinence from heterosexual activity OR by using 2 allowable methods of birth control during heterosexual activity.
- •7) Voluntarily agrees to participate (or legally acceptable representative, for minors, if applicable); and provide written informed consent/assent for the trial. The participant may also provide consent/assent for Future Biomedical Research. However the participant may participate in the main trial without participating in Future Biomedical Research
- •8) Be able to complete all scheduled visits and to comply with the study procedures
- •9) Agrees to provide study personnel with a primary telephone number as well as an alternate form of contact, if available, for follow-up purposes
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. 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
- •2. Has a history of any allergic reaction or an anaphylactic/anaphylactoid reaction to any vaccination that required medical intervention, or of any severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension, or shock), to any vaccine component that required medical intervention
- •3. Has a recent (<72 hours) history of febrile illness (temperature =100.4°F/38.0°C, oral equivalent)
- •4. 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. No testing for HIV will be required in the study
- •5. Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access
- •6. 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. If the urine test on the day of vaccination cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. If pregnancy is diagnosed any time after the first dose but before the completion of the vaccination series, the participant is excluded from any remaining vaccinations but is included in the study for safety follow-up
- •7. Has previously received a CMV vaccine
- •8. 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
- •9. Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following, any dose of trial vaccine
- •10. Had administration of any immune globulin or blood product within 90 days prior to injection with V160/placebo or scheduled within 30 days thereafter
- •11. Has 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
- •12. Has 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)
- •13. Has 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. Anti-viral agents prohibited include letermovir, ganciclovir, valganciclovir, foscarnet, cidofovir, and valacyclovir.
- •14. Is receiving or has received in the year prior to enrollment immunosuppressive therapies including but not limited to rapamycin (also sirolimus), tacrolimus (also FK-506 or Fujimycin), or other therapies used for solid organ/cell transplant, radiation therapy
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