Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel � as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults
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Last updated:12th Dec 2013
The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 �g dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel� in healthy European adults not previously exposed to the parasite P.falciparum and in healthy African adults exposed to the parasite. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions. The safety profile will include local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria.
|Study start date||2013-12-12|