Download overview of ebola ii study design

OVERVIEW OF EBOLA II STUDY DESIGN
A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety,
Tolerability and Immunogenicity of Three Prime-boost Regimens of the Candidate Prophylactic
Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly
Subjects, HIV-infected Subjects, and Healthy Children in Three Age Strata in Africa.
The sponsor, in collaboration with Bavarian Nordic GmbH (BN) and in conjunction with an
Innovative Medicines Initiative (IMI) consortium led by the Institut National de la Santé et de la
Recherche Médicale (INSERM), 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.
In this Phase 2 study, the sponsor’s adenovirus serotype 26 (Ad26) vector expressing the EBOV
Mayinga GP (Ad26.ZEBOV) and the MVA-BN vector with EBOV, SUDV and MARV GP
inserts and TAFV NP insert (MVA-BN-Filo) will be evaluated as a heterologous prime-boost
regimen, in which one study vaccine (Ad26.ZEBOV) is used to prime a filovirus-specific
immune response and the other study vaccine (MVA-BN-Filo) is used to boost the immune
response 28, 56 or 84 days later. The EBOV GP that is currently circulating in West Africa has
97% homology to the EBOV GP used in this vaccine regimen.