| Protocol No: | ECCT/16/11/05 | Date of Protocol: | 08-03-2016 |
| Study Title: | A randomized, obsever-blind, placebo controlled, two-part, Phase 2 study to evaluate the Safety, Tolerability and Immunogenicity of Two prime-boost regimen of the candidate Prophylactic vaccines for Ebola Ad26-ZEBOV and MVA-BN Filo. |
| Study Objectives: |
Primary Objectives
• To assess the safety and tolerability of different vaccination schedules of Ad26.ZEBOV and
MVA-BN-Filo administered intramuscularly (IM) as heterologous prime-boost regimens in healthy
adults and in HIV-infected adults, with Ad26.ZEBOV prime and MVA-BN-Filo boost vaccination
on Days 1 and 29, respectively and MVA-BN-Filo prime and Ad26.ZEBOV boost vaccination on
Days 1 and 15, respectively.
• To assess the immune responses to the EBOV GP (as measured by [enzyme-linked immunosorbent
assay] ELISA antibody concentration) of different vaccination schedules of Ad26.ZEBOV and
MVA-BN-Filo administered IM as heterologous prime-boost regimens in healthy adults and in
HIV-infected adults, with Ad26.ZEBOV prime and MVA-BN-Filo boost vaccination on Days 1 and
29, respectively and MVA-BN-Filo prime and Ad26.ZEBOV boost vaccination on Days 1 and 15,
respectively.
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| Laymans Summary: |
The sponsor, in collaboration with Bavarian Nordic GmbH (BN) and Walter Reed Army Institute of Research (WRAIR), is investigating the potential of a prophylactic Ebola vaccine regimen comprised of the following 2 candidate Ebola vaccines: Ad26.ZEBOV is a monovalent vaccine expressing the full length Ebola virus (EBOV, formerly known as Zaire ebolavirus) Mayinga glycoprotein (GP), and is produced in the human cell line PER.C6®. MVA-mBN226B, further referred to as Modified Vaccinia Ankara (MVA)-BN-Filo®, is a multivalent vaccine expressing the Sudan virus (SUDV) GP, the EBOV GP, the Marburg virus (MARV) Musoke GP, and the Tai Forest virus (TAFV, formerly known as Côte d’Ivoire ebolavirus) nucleoprotein (NP), and is produced in chicken embryo fibroblast cells. The EBOV GP expressed by MVA-BN-Filo has 100%
homology to the one expressed by Ad26.ZEBOV.
Two populations will be studied in this protocol: healthy adults and human immunodeficiency virus (HIV)-infected adults, ages 18-70 years inclusive, will be enrolled.
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| Abstract of Study: | The abstract/synopsis of this protocol is detailed on Page 15 of the protocol attached. |