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Development of a Prophylactic Ebola Vaccine Using an Heterologous Prime-Boost Regimen – Sofia ref.: 115854

Projektbeschreibung

Neuartige vorbeugende Impfstoffe gegen das Ebola-Virus

Das übergeordnete Ziel des EBOVAC-Programms ist die Durchführung aller Phasen klinischer Studien zur Bewertung der Sicherheit und Wirksamkeit neuartiger vorbeugender Ad26.ZEBOV- und MVA-BNFilo-Impfstoffe gegen die Ebola-Viruskrankheit. Die beschleunigte Entwicklung des Impfschemas erfordert, dass Phase II- und Phase III-Studien von separaten Teams parallel durchgeführt werden. Im Rahmen des EU-finanzierten Projekts EBOVAC1 sind sowohl Phase I- als auch Phase III-Studien geplant. Die anfängliche Sicherheit und Immunogenität des vorgeschlagenen Boost-Schemas wird in Phase I-Studien durch die Verabreichung der Impfstoffe in verschiedenen Sequenzen und in unterschiedlichen Zeitabständen bewertet, um den kürzesten immunogenen Zeitplan zu ermitteln, der das Potenzial für die Wirksamkeit in von der Ebola-Viruskrankheit betroffenen Ländern maximiert.

Ziel

The overall aim of the EBOVAC programme is to assess the safety and efficacy of a novel prime boost prophylactic vaccine regimen against Ebola Virus Disease (EVD), which has been 100% effective in preclinical studies. This will be done via phase I, II and III trials carried out in the EU and in Africa, in response to the urgent public health need raised by the current Ebola epidemic. To expedite the development of the vaccine regimen, Phase II and Phase III trials will be carried out in parallel and therefore co-ordinated by two separate teams. Proposals responding to IMI2 Topic 1 will consequently be split into two parts. EBOVAC1 will address the Phase I and Phase III trials, whereas EBOVAC2 will address the Phase II trials.


EBOVAC1 will establish the initial safety and immunogenicity of the proposed heterologous prime/ boost regimen of Ad26.ZEBOV and MVA-BNFilo vaccine through phase I studies conducted in the UK, the US and currently Ebola- unaffected African countries. This will be done by administering the vaccine in different sequences and at different time intervals so as to identify the shortest schedule that is immunogenic and to maximize the potential for short term efficacy in affected countries. Initiation of these trials is expected to occur between December 2014 and March 2015 and approximately 300 subjects will be enrolled.


The main objective therefore of EBOVAC 2 is to provide extensive and robust data on the safety, immunogenicity and efficacy of the Ad26.ZEBOV and MVA-BN-Filo vaccine.


This will be done by:

1. Carrying out translational studies to link vaccine elicited immune responses in humans to protection from Ebola in vaccinated non-human primates (via WP4)
2. Carrying out Phase II trials in African and European volunteers in 6 countries, four in Africa and two in the EU with an overall target enrolment of approximately 1,500 subjects. Given the compressed nature of this development program, the Phase II studies will be conducted in parallel

Koordinator

LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
Netto-EU-Beitrag
€ 47 208 317,53
Adresse
KEPPEL STREET
WC1E 7HT London
Vereinigtes Königreich

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Region
London Inner London — West Camden and City of London
Aktivitätstyp
Higher or Secondary Education Establishments
Links
Gesamtkosten
€ 47 208 317,53

Beteiligte (6)