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A Phase II Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers


Phase 2
18 Years
30 Years
Not Enrolling
Female
Prophylaxis HPV-16/18 Infections and Cervical Neoplasia

Thank you

Trial Information

A Phase II Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers


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 formulated with aluminum hydroxide, with doses administered at 0, 30
and 180 days. Healthy female volunteers 18 through 30 years of age will be entered into 4
treatment arms. The objectives of study are to evaluate reactogenicity, safety and
immunogenicity.


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Solicited adverse event rates (including injection site and systemic reactions)

Outcome Time Frame:

For 7 days after each injection

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

580299/005

NCT ID:

NCT00693966

Start Date:

October 1999

Completion Date:

September 2004

Related Keywords:

  • Prophylaxis HPV-16/18 Infections and Cervical Neoplasia
  • HPV, Vaccine
  • Neoplasms

Name

Location

GSK Clinical Trials Call CenterHoover, Alabama  35216
GSK Clinical Trials Call CenterNew Orleans, Louisiana  70112
GSK Clinical Trials Call CenterAlbany, New York  12208
GSK Clinical Trials Call CenterCleveland, Ohio  44106-5065
GSK Clinical Trials Call CenterFort Worth, Texas  76104
GSK Clinical Trials Call CenterSalt Lake City, Utah  84109