Karen R. Charron




My research interests are primarily related to the conduct of clinical vaccine trials. I have served as co-investigator for numerous Phase I/II adult and pediatric vaccine trials of hepatitis B vaccines, preventive and therapeutic HIV vaccines, respiratory syncytial virus vaccines, rotavirus vaccines, dengue vaccines, and influenza virus vaccines. My secondary area of interest is related to training of investigators and clinical teams for the clinical vaccine trial conduct, with a special emphasis on training investigators from developing countries. This includes applications of vaccine trials in accordance with the International Conference on Harmonisation (ICH) guidelines on the standards of Good Clinical Practice (GCP) and FDA and OHRP clinical trial regulations. Specific areas include: protocol development, partnerships in vaccines, human subjects protection, the informed consent process; data management; community education; recruitment; screening; investigational product management; protocol implementation, adverse event management, and standard operating procedures. This curriculum has evolved into the development of a distance education course entitled Clinical Vaccine Trials and Good Clinical Practice ntation which can be found at http://distance.jhsph.edu/vactrial. This course is taught both 1st and 4th term of each academic year. I also develop and teach international regional workshops related to clinical vaccine trials.

I serve as the Assistant Director of Academic Programs for the Disease Prevention and Control Program coordinating the Masters of Health Sciences degree. I am always interested in speaking with potential students.

More info: http://www.hopkinsglobalhealth.org/researchers/profile/851/Charron/KarenR

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Jun 24th 2013

This course will explore the process of evaluating investigational vaccines in clinical trials including informed consent, recruitment, enrollment, safety evaluation, and quality data collection.

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