Status:
COMPLETED
Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
18-30 years
Phase:
PHASE2
Brief Summary
The goals of this study are to describe the safety, reactogenicity and immunogenicity of MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected. This study was ori...
Detailed Description
This is a Phase II, double-blind, randomized, comparative trial of three formulations of MEDI-517 given at 0, 30, and 180 days by intramuscular injection. The volunteers in this study will be healthy ...
Eligibility Criteria
Inclusion
- Females 18 through 30 years of age (must not have reached the 31st birthday)
- Written informed consent obtained from the volunteer
- 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
- Must have a negative serum pregnancy test within 21 days of study entry and must not be breast feeding
- 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 physical findings suggestive of other gynaecologic pathogens on pelvic examination within 21 days of study entry
- Agrees to no other vaccines or experimental therapy until 30 days after the last study injection
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
- 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
- Abnormal laboratory blood values at screening. 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 abnormal Pap smear (other than a single prior report of ASCUS or indeterminate Pap smear with a subsequent normal report)
- Genital herpes disease involving the cervix or with disease characterized on examination or by history by extensive external lesions. Volunteers with a history of recurrent genital herpes disease characterized by limited external lesions are eligible to participate in the study.
- 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 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00693615
Start Date
October 1 2000
End Date
January 1 2005
Last Update
September 16 2016
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