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Phase 1 trial of AMA1-C1/Alhydrogel plus CPG 7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria

This is the first reported use in humans of an investigational vaccine, AMA1-C1/Alhydrogel, with the novel adjuvant CPG 7909. This large interdisciplinary (n=75) trial demonstrated safety and immunogenicity. It was the basis of further clinical development of the malaria vaccine, later evaluated in trial in Africa. It provided safety data supporting the adjuvant in several vaccines and has been studied in >40 FDA approved trials in infection, oncology and allergy. It is under evaluation as an alternate adjuvant for existing and experimental vaccines to improve immunogenicity and safety. Mullen led the design of the study and analysis of the data.