should aggressively move into clinical trials to test specific vaccine products, and select two to three leads at phase 1 and one lead at phase 2 for each strategy. For protein-based and gene-based strategies, the focus should be on specific vaccine products that combine the lead antigens (CSP, SSP-2/TRAP, LSA-1, AMA-1, and MSP-1) including their use in heterologous prime-boost combinations.

Recommendation 4.4: Finding correlates for protection in humans relevant to each of the above vaccine strategies should be a research priority.

Recommendation 4.5: The MIDRP Malaria Vaccine Program should continue research on human immune processes and responses to malaria. The current incomplete understanding of the mechanisms of protective immunity to malaria in humans constitutes a barrier that impedes malaria vaccine development.

After thorough review of the MIDRP Malaria Vaccine Program in order to understand the current situation and the program’s quality, the committee concluded that it is crucial to narrow the focus to a smaller number of candidate antigens. Given the limited time available for this review, the committee did not wish to give more detailed specific advice other than that given above and in Recommendation 4.3. Despite having extensive expertise in all scientific aspects of the program, the committee concluded that instead of offering one-time advice on specific antigens or approaches, it would be more productive to recommend a structure and process for ongoing review and decision making about the scientific direction of the work.

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