Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females

This study has been completed.
Sponsor:
Collaborator:
MedImmune LLC
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00693966
First received: June 5, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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 HPV DNA. The study is designed to evaluate safety and immunogenicity data for MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will provide long-term immune response data.

This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.


Condition Intervention Phase
Prophylaxis HPV-16/18 Infections and Cervical Neoplasia
Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)
Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)
Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)
Biological: MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)
Phase 2

Study Type: 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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Solicited adverse event rates (including injection site and systemic reactions) [ Time Frame: For 7 days after each injection ]
  • Unsolicited adverse event rates [ Time Frame: For 30 days after each injection ]
  • Serious adverse event rates [ Time Frame: From first injection through 30 days after last injection ]
  • Laboratory assessments (Biochemistry and Hematology parameters) [ Time Frame: Study Days 0, 30 and 210 ]
  • Vital signs (temperature, blood pressure, pulse rate, respiratory rate) [ Time Frame: At the time of injection and 30 minutes after the injection ]
  • Serum ELISA titers against HPV-16 and HPV-18 [ Time Frame: 30 days after the third injection ]

Secondary Outcome Measures:
  • Serum ELISA titers against HPV-16 and HPV-18 [ Time Frame: Study Days 0, 7, 30, 60, 180, 210, and 360, and at 24, 36, and 48 months ]
  • Neutralization titers against HPV-16 and HPV-18 [ Time Frame: Study Days 0, 60, 210 and 360 ]
  • Cell-mediated immunity by IL-5, IFN-γ and lymphoproliferative assays [ Time Frame: Study Days 0, 60, 210, and 360 ]
  • HPV-16 and HPV-18 ELISA and inhibitory ELISA [ Time Frame: Study Days 0, 60, 210, and 360, and at 18, 24, 36, and 48 months ]
  • Cervical and vaginal ELISA titers against HPV-16 and HPV-18 [ Time Frame: At Study Days 210 and 360 ]

Enrollment: 210
Study Start Date: October 1999
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Formulation 1 of the vaccine (MEDI-517 HPV-16/18 VLP AS04 vaccine)
Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)
IM injection
Experimental: Group B
Formulation 2 of the vaccine
Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)
IM injection
Experimental: Group C
Formulation 3 of the vaccine
Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)
IM injection
Experimental: Group D
Formulation 4 of the vaccine [with Al(OH)3]
Biological: MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)
IM injection

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693966

Locations
United States, Alabama
GSK Clinical Trials Call Center
Birmingham, Alabama, United States, 35294
United States, Louisiana
GSK Clinical Trials Call Center
New Orleans, Louisiana, United States, 70112
United States, New York
GSK Clinical Trials Call Center
Rochester, New York, United States, 14642
United States, Ohio
GSK Clinical Trials Call Center
Cincinnati, Ohio, United States, 45229
United States, Texas
GSK Clinical Trials Call Center
Austin, Texas, United States, 78704
United States, Utah
GSK Clinical Trials Call Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
GlaxoSmithKline
MedImmune LLC
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00693966     History of Changes
Other Study ID Numbers: 580299/005, MI-CP057
Study First Received: June 5, 2008
Last Updated: June 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HPV, Vaccine

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014