Status:
COMPLETED
Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
18-30 years
Phase:
PHASE2
Brief Summary
The purpose of this Phase II study is to provide data regarding the safety and immunogenicity for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative for high-risk ...
Detailed Description
This is a Phase II double-blind, randomized, dose-comparison, multicenter study in the United States of three different dose levels of MEDI-517 (HPV-16/18 VLP AS04 vaccine) and one dose of MEDI-517 fo...
Eligibility Criteria
Inclusion
- Females 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 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
- Seronegative for HPV-16 and HPV-18 antibody by ELISA within 21 days of study entry
- Cervical specimen negative for high-risk HPV DNA using the Digene Hybrid Capture® II HPV test (high-risk types Probe B) within 21 days of study entry
- Normal Pap smear, using the Cytyc ThinPrep® Pap Test, within 21 days of study entry
- 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
- Acute illness or fever (oral temperature ≥ 99.5°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 within the previous 90 days or history of immunodeficiency
- History of cancer
- History of alcohol or drug abuse within the past 2 years
- 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 abnormal Pap smear (other than a single prior report of ASCUS or indeterminate Pap smear with a subsequent normal report)
- Positive tests for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 antibody
- Any prior receipt of any vaccine (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 6 months of randomization (local therapy for common skin and/or plantar warts is allowed)
- Previous administration of any components of the investigational vaccine
- 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
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00693966
Start Date
October 1 1999
End Date
September 1 2004
Last Update
September 16 2016
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