Last updated: 11/04/2018 03:37:49

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

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GSK study ID
580299/005
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Clinicaltrials.gov ID
NCT00693966
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: For 7 days after each injection

Unsolicited adverse event rates

Timeframe: For 30 days after each injection

Serious adverse event rates

Timeframe: From first injection through 30 days after last injection

Laboratory assessments (Biochemistry and Hematology parameters)

Timeframe: Study Days 0, 30 and 210

Vital signs (temperature, blood pressure, pulse rate, respiratory rate)

Timeframe: At the time of injection and 30 minutes after the injection

Serum ELISA titers against HPV-16 and HPV-18

Timeframe: 30 days after the third injection

Secondary outcomes:

Serum ELISA titers against HPV-16 and HPV-18

Timeframe: 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

Timeframe: Study Days 0, 60, 210 and 360

Cell-mediated immunity by IL-5, IFN-γ and lymphoproliferative assays

Timeframe: Study Days 0, 60, 210, and 360

HPV-16 and HPV-18 ELISA and inhibitory ELISA

Timeframe: 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

Timeframe: At Study Days 210 and 360

Interventions:
  • Biological/vaccine: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)
  • Biological/vaccine: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)
  • Biological/vaccine: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)
  • Biological/vaccine: MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)
    • Enrollment:
    210
    Primary completion date:
    2004-30-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.
    Giannini S et al. (2006) Enhanced humoral and memory B cellular immunity using HPV 16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine. 24(33-34):5937-5949.
    Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
    Medical condition
    Infections, Papillomavirus
    Product
    Human Papillomavirus Types 16 and 18 Vaccine
    Collaborators
    Not applicable
    Study date(s)
    October 1999 to September 2004
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female
    Age
    18 - 30 years
    Accepts healthy volunteers
    Yes
    • 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
    • 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
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2004-30-09
    Actual study completion date
    2004-30-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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