A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Partici… (NCT02543567) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
United States525 participantsStarted 2015-09-21
Plain-language summary
The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA-BN-Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (glycoprotein) as measured by enzyme-linked immunosorbent assay (ELISA) at 21 days post boost.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria :
* Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
* Must be healthy on the basis of clinical laboratory tests performed at Screening
* Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal \[greater than (\>)\] 45 years of age with amenorrhea for at least 2 years or any age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level \>40 international unit per milliliter (IU/L); permanently sterilized (for example, bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
* Woman of childbearing potential must have a negative serum \[beta-human chorionic gonadotropin (beta-hCG)\] at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
* Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to Screen…
What they're measuring
1
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)