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The study was conducted as a single-blind, randomized, dose escalating Phase 1 clinical trial in healthy volunteers, designed to evaluate the safety, reactogenicity, and immunogenicity of the AMA1-C1 vaccine formulated on Alhydrogel and mixed with CPG 7909. The study was performed in three sequential cohorts, and escalation between cohorts did not occur until the previous cohort had received two vaccinations and the safety data from this group had been reviewed by a Safety Monitoring Committee.
The study was conducted under a protocol reviewed and approved by the Institutional Review Board (IRB) of the National Institute of Allergy and Infectious Disease (NIAID), and by the University of Rochester Research Subjects Review Board. The study was submitted to the U.S. Food and Drug Administration for review as part of Investigational New Drug application BB-IND#12029. The study was monitored for regulatory compliance and data quality by the Division of Microbiology and Infectious Diseases (DMID) of NIAID. Written informed consent was obtained from all volunteers prior to screening for eligibility for participation
The frequency of adverse events stratified by dose cohort was summarized. Logistic regressions were used to investigate the effect of dose group on either local, systemic or laboratory adverse events. In each logistic regression, the response used for each subject was the most severe response observed, and all subjects were included regardless of withdrawal status. For the local or systemic reactions separate regressions were done for the odds of experiencing any reaction (mild, moderate, or severe vs. none) or higher severity reactions (moderate or severe vs. none or mild). When a dose group effect was found to be significant, pairwise tests using the same model were used to further investigate specific comparisons. No corrections were made for multiple comparisons. Statistical analysis for adverse events was performed by an independent data management group (EMMES Corporation) using SAS Version 9.1 (SAS Institute Inc., Cary, NC), and results were reviewed by the study statistician (MPF).
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