A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA‐BN‐Filo in Healthy Adult Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:2/9/2017
Start Date:September 2015
End Date:November 2016

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A Phase 3, Randomized, Double‐Blind, Placebo‐Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime‐Boost Regimen of Ad26.ZEBOV and MVA‐BN®‐Filo in Healthy Adult Subjects

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.

This is a randomized, double‐blind, placebo‐controlled, parallel‐group, multicenter study to
evaluate safety and immunogenicity of Ad26.ZEBOV and MVA‐BN‐Filo at different dose levels,
administered to healthy adults participants. The study consists of a Screening period of up
to 6 weeks, vaccinations on Day 1 and Day 57, and a post‐vaccination phase until the 6
months post‐boost visit (Day 237). The participants will be randomized at baseline (on Day
1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the
study.

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 Screening must be willing to use
condoms for sexual intercourse beginning prior to enrollment, in addition to the
birth control method used by the female partner

Exclusion criteria:

- Having received a candidate Ebola vaccine

- Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including
travel to West Africa less than 1 month prior to Screening. West Africa includes but
is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone

- Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or
Modified Vaccinia Ankara (MVA)‐ based vaccine in the past

- Known allergy or history of anaphylaxis or other serious adverse reactions to
vaccines or vaccine products (including any of the constituents of the study
vaccines) including known allergy to egg, egg products and aminoglycosides

- Presence of acute illness or temperature greater than or equal to (>=) 38.0 (°C)
centigrade on Day 1
We found this trial at
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