ZIA CP010177-01052 (ZIA) | |||
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Title | HPV Vaccine Trials | ||
Institution | NCI, Bethesda, MD | ||
Principal Investigator | Hildesheim, Allan | NCI Program Director | N/A |
Cancer Activity | N/A | Division | DCEG |
Funded Amount | $3,011,723 | Project Dates | 12/01/2000 - N/A |
Fiscal Year | 2009 | Project Type | Intramural |
Research Topics w/ Percent Relevance | Cancer Types w/ Percent Relevance | ||
Biochemical Epidemiology (45.0%) Cancer (100.0%) |
Cervical Cancer (100.0%) | ||
Research Type | |||
Endogenous Factors in the Origin and Cause of Cancer Vaccines |
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Abstract | |||
This clinical trial is to evaluate the prophylactic efficacy of two HPV 16 VLP-based vaccines developed at NCI. Participants will be randomized into one of three arms (two experimental arms and a placebo arm). The vaccine will be administered without adjuvant, since early trials suggested increased ractogenicity without parallel increases in immunogenicity among volunteers vaccinated with VLP plus adjuvant. Three doses will be administered intramuscularly at entry, one month, and six months. Each woman will be followed with yearly clinic visits and pelvic exams for four years to obrain information on long-term side effects, to evaluate immunogenicity over time, and to determine wheather vaccination protects against the development of persistent HPV16 infection and/or HPV16 positive SIL. Numerous secondary objectives are also planned. |