OVERVIEW OF EBOLA II STUDY DESIGN

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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.

 

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Contacts

KAVI Institute of Clinical Research (KAVI-ICR)

College of Health Sciences

University of Nairobi

P.O. Box 19676 - 00202

Nairobi,

Kenya.

 

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Mobile: +254-722-207417

 

Fax: +254-20-2714613

 

E-mail: kavi@kaviuon.org

 

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