Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive

MedImmune

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy

Treatments

Other: Aluminum hydroxide

Biological: MEDI 517

Study type

Interventional

Funder types

Industry

Identifiers

NCT00263744

MI-CP058

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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