Any proposals will be considered, including those addressing the potential for immediate or future combinations of two or more components. (For definition of combination vaccines and reflection on the many challenges facing development of combination vaccines, please refer to EMVI’s web site http://www.emvi.org/meeting+reports.)

EMVI’s Scientific Advisory Committee (SAC) of independent scientists, - please refer to http://www.emvi.org assisted by other experts as the need arises, will review the proposals.

EMVI actively collaborates with among others the international malaria vaccine funders mentioned on the website www.emvi.org, and is a partner in the European and Developing Countries Clinical Trials Partnership (EDCTP).

In elaborating a proposal you are advised to address the following key issues systematically.

1) Epidemiology:
What is known and what information is lacking?
Are epidemiological studies needed for the development of the vaccine?
If known, what is (are) the hypothetical or assumed correlate(s) of protection or immunity in target populations?

2) Scientific rationale:
a) Background:
Target populations: age, geographical zones, special risk groups. Are there genetic (haplotype)differences in populations that do better than others, immunologically and clinically?
b) Antigen choice; stage specific or multistage, pros and cons
Single or multiple antigens
Is it known the antigen an essential gene?
Document genetic variability?
Any homology with human proteins?
What is the immune response to this (these) antigen(s) in naturally exposed populations?
Are certain immune responses correlated to better clinical outcomes?
What are the theoretical/hypothetical reasons why an immune-response to this (these) antigen(s)would be detrimental to the parasite?
Are there in-vivo or in-vitro tests to support this?
Expected performance of the vaccine.
What would the investigator consider the best proof of concept test that could be designed?
c) Choice of vector/formulation/antigen-presentation/expression system
Does the investigator know what type of immune-response needs to be induced?
Has an antigen delivery system that achieves the required response been identified?
Is this system validated in humans? in animals? as a viable option for wide spread/scale-up and use? Discuss advantages and limitations
Competing products: Other vaccines, other available products
d) Preclinical development:
Correlates of protection; development of immunological tests for the assessment of the quality of the immune response; animal models
e) Route of administration:
Is there any data to support alternative routes of administration of interest for the antigen?
f) Summary of clinical development to date, if any

3) Vaccine production:
What are the plans for process development/manufacturing?
Is an adjuvant needed?
What reagents will have to be developed to control product and its immunogenicity?
What assays need to be developed or validated prior to initiating clinical trials?
Quality control studies:
Animal studies including pharmaco-toxicological studies
Stability studies
Potency assay
Are the tests already developed? Are there already any product characteristics and product specifications available?

4) Clinical development strategy:
Describe the intended clinical development strategy, including primary and secondary clinical endpoints, which will result in a clear decision to proceed to development with a well-defined product and with reasonable probability of success.
Define the rationale for phase 1 - 2a studies.
Are there pivotal studies that would form the basis for GO/NO-GO decisions?
Define hypothesis, objectives, main outcome measurement, study design and time-lines.

The proposal-text should not exceed 25 (twenty-five) pages. The operational plans should be explained in work packages. The number of work packages should not exceed 6 (six). Elaboration of ethical aspects and the benefits for target populations is also required.

The proposal does not need to be anonymous, and relevant literature should be referred to in the text, and a list of references should be provided as the ultimate page(s) in the application Application Form.

Manuscripts submitted, but not yet published, can be attached, and essential research results not yet ready for submission can be submitted together with the proposal in a format, which describes and discusses the results, strictly to substantiate the proposal. Relevant reprints can be annexed.

The penultimate page of the proposal should be a budget outline relating to each work package.

Proposals will be dealt with in confidence. They should be e-mailed to:

Additional information is available from Dr. Odile Leroy or Dr Babatunde Imoukhuede.

A decision will be communicated to applicants by mid February 2008.