Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a
 control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16
 and/or HPV-18 DNA detected in cervical brushings.
Inclusion Criteria:

 -  Female

 -  18 through 30 years of age (must not have reached the 31st birthday)

 -  Unless previously surgically sterilized, agrees to use an effective method of birth
 control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives,
 diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant®
 or DepoProvera®) beginning 30 days before the first study injection and continuing
 through 60 days after the final study injection

 -  Healthy by medical history and physical examination

 -  Cervical specimen positive for HPV-16 and/or HPV-18 DNA using the Digene Hybrid
 Capture® II HPV test within 21 days of study entry

 -  Cervical cytology by Pap smear that is either normal or no greater than ASCUS or
 AGCUS, using the Cytyc ThinPrep® Pap Test, within 21 days of study entry (a normal Pap
 smear must also be adequate for interpretation; a Pap smear that is normal but
 inadequate for interpretation must be repeated). Those volunteers with ASCUS or AGCUS
 must have had a clinical evaluation by colposcopy within the previous month which
 showed no evidence of CIN or SIL.

 -  No evidence of anogenital HPV lesions or no physical findings suggestive of other
 gynecologic pathogens on pelvic examination within 21 days of study entry

 -  Agrees to no other experimental therapy or vaccines until 30 days after the last study
 injection

 -  Written informed consent obtained from the volunteer

 Exclusion Criteria:

 -  Acute illness or fever (oral temperature ³99.5°F [37.5°C]) at start of the study

 -  History or clinical manifestations of significant medical or psychiatric disorder

 -  Pregnant or lactating

 -  Use of immunosuppressive medication (inhaled and topical corticosteroids are
 permitted) within the previous 90 days or history of immunodeficiency

 -  History of cancer

 -  History of alcohol or drug abuse within the past 2 years

 -  At screening (must be within 21 days of study entry) any of the following: hemoglobin
 <11 gm/dL; white blood cell count <4000/mm3; platelet count <120,000/mm3; AST, ALT,
 creatinine >1.5x upper limit of normal for the laboratory in question; other abnormal
 laboratory values in the screening panel which in the opinion of the principal
 investigator are judged to be clinically significant

 -  Receipt of immunoglobulin or blood products within 90 days prior to study entry

 -  History of Pap smear more severe than ASCUS or AGCUS

 -  Positive tests for hepatitis C antibody, hepatitis B surface antigen, or HIV-1
 antibody

 -  Any prior receipt of any vaccine or therapy (experimental or otherwise) for treatment
 or prophylaxis of genital warts or other papillomavirus related condition. Any
 treatment of genital warts or other papillomavirus related condition within six months
 of randomization (local therapy for common skin and/or plantar warts is allowed)

 -  Prior receipt of any vaccine containing monophosphoryl lipid A or SBAS4 adjuvant (no
 vaccines currently licensed contain these)

 -  Receipt of any experimental vaccine within 90 days prior to entry into this study

 -  Receipt of any experimental drug therapy within 30 days or five half-lives of the
 experimental drug (if the half-life is known), whichever is longer