This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The study will enroll a total of 96 healthy male and female volunteers aged 18 to 45 years in the United States. Participating sites include Vanderbilt University Medical Center, Nashville, Tennessee and Stanford University, Stanford California. The study duration will be approximately 7 months per subject, to be followed by annual phone calls for a period of five years for serious adverse event assessment. The investigational agent is an Adenovirus Type 35 Circumsporozoite Malaria Vaccine (Ad35.CS.01) which will be compared with a Normal Saline Placebo Control via Intramuscular Injection. Volunteers will be randomized in a 5:1 ratio to receive 3 doses of the vaccine or normal saline placebo control by the intramuscular route at 0, 1 and 6 months. The safety, reactogenicity and immunogenicity of ascending dosages of the vaccine will be assessed. Fifteen volunteers will receive vaccine at each of the following dosage levels: 108 viral particles (vp)/ml and 109vp/ml with three volunteers receiving placebo control at each of these dosage levels. Twenty-five volunteers will receive vaccine at each of the next dosage levels of 1010vp/ml and 1011vp/ml with five volunteers receiving placebo control at each of these dosage levels. Dosage escalation will proceed only after review of the safety data after the initial dose of the prior dosage level.
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