AMANET Call
for European Candidate Malaria Vaccines Ready for Clinical
Development in Africa.
Download call in Adobe PDF
Background
The mission of AMANET is to promote capacity
strengthening and networking of malaria R&D in
Africa. Presently, the focus is on the development
of candidate malaria vaccines which meet relevant
requirements and are ready for evaluation in
malaria-endemic areas at phase I and II clinical
trials. This is complimented with capacity
strengthening and site development activities for
strategically preparing African research centres to
undertake the clinical evaluation of potential
candidate vaccines according to ICH-GCP guidelines.
The role of AMANET in malaria R&D is based on the
need to shorten the time and investment between
discovery of potential interventions and their
deployment. Recognising the lack of mechanisms
outside pharmaceutical industry for developing
malaria vaccines, the European Commission’s
EuropeAid Co-operation (AIDCO) has made funds
available to AMANET to enable this as well as build
its own capacity for undertaking the responsibility
of the sponsor of clinical trials under
international guidelines and standards.
This call is inviting European scientists or
institutions who are interested in collaborating
with AMANET and have malaria vaccine candidates
which are ready for clinical evaluation in Africa.
What AMANET is offering
-
Not-for-profit investment in farther clinical development of
candidate malaria vaccines
-
Role
of sponsor for phase I and II vaccine trials within Africa
-
Funding of phase I and II malaria vaccines clinical trials
in African malaria-endemic countries
-
Clinical evaluation centres prepared for malaria vaccine
trials
-
Efficient, flexible and transparent decision-making
mechanisms
-
Partnership in vaccine development including possibility to
out-source relevant specialised activities.
Who can apply?
European scientists and institutions that hold patents over
malaria vaccine candidate molecules which meet the profile for
endemic country evaluation are invited. The restriction to
European products is a requirement from the funding authority.
Vaccine candidate profile
The following are important considerations for the vaccine to
be acceptable to this call:
-
Documentation to demonstrate ownership of the molecule by
the applying institution or scientist
-
Proven and convincing vaccine development rationale as
evidenced in published preclinical studies
-
Completion of adequate preclinical and toxicological
evaluation in at least two animal models
-
Demonstrated safety in humans in a phase Ia trial
-
Certification of current Good Manufacturing Practice (cGMP)
for all the clinical lots used in the early development of
the product
-
Acceptable batch release protocol/certificate for the
clinical lots
-
Feasibility of vaccine production up-scaling under cGMP
conditions
-
Provision of up-to-date Investigator’s Brochure (IB) and
sufficient information for European regulatory registration
of the product
-
Provision of all information necessary for developing a
comprehensive clinical development plan
-
Agreement to make vaccine readily accessible at affordable
cost in Africa should it eventually become licensed
-
Willingness to work with other collaborators such as EDTCP
How to apply
Interested persons/institutions should submit a letter of
interest highlighting the above requirements and curriculum
vitae of the involved key scientists.
All applications must be directed to:
The Managing Trustee,
African Malaria Network Trust (AMANET)
Tanzania Commission for Science and Technology building,
Ali Hassan Mwinyi Road,
P O Box 33207, Dar es Salaam,
Tanzania.
Tel: + 255-22-2700018, Fax: + 255-22-2700380.
E-mail:
info@amanet-trust.org or
wlkilama@amanet-trust.org
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