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Infections, PapillomavirusPhase 2NCT00693966

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

A Phase 2 study testing MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1), MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2) and MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3) in people with Infections, Papillomavirus, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 HPV DNA. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infections, Papillomavirus
What is being tested?
MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1), MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2) and MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
Oct 1999to Sep 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

About this study

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

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.

Read the 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.

Being tested
MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1), MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2), MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3), MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)
Keywords
HPV, Vaccine
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)Biological

    IM injection

  • MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)Biological

    IM injection

  • MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)Biological

    IM injection

  • MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)Biological

    Also called MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2), MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3), MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)

    IM injection

Study groups in NCT00693966
Study groupRoleWhat they receive
Group AExperimentalFormulation 1 of the vaccine (MEDI-517 HPV-16/18 VLP AS04 vaccine)
Receives: Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1)
Group BExperimentalFormulation 2 of the vaccine
Receives: Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2)
Group CExperimentalFormulation 3 of the vaccine
Receives: Biological: MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3)
Group DExperimentalFormulation 4 of the vaccine [with Al(OH)3]
Receives: Biological: MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: For 7 days after each injection

  2. Unsolicited adverse event rates

    Measured: For 30 days after each injection

  3. Serious adverse event rates

    Measured: From first injection through 30 days after last injection

  4. Laboratory assessments (Biochemistry and Hematology parameters)

    Measured: Study Days 0, 30 and 210

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

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

  6. Serum ELISA titers against HPV-16 and HPV-18

    Measured: 30 days after the third injection

Secondary outcomes (5)

  1. Serum ELISA titers against HPV-16 and HPV-18

    Measured: Study Days 0, 7, 30, 60, 180, 210, and 360, and at 24, 36, and 48 months

  2. Neutralization titers against HPV-16 and HPV-18

    Measured: Study Days 0, 60, 210 and 360

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

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

  4. HPV-16 and HPV-18 ELISA and inhibitory ELISA

    Measured: Study Days 0, 60, 210, and 360, and at 18, 24, 36, and 48 months

  5. Cervical and vaginal ELISA titers against HPV-16 and HPV-18

    Measured: At Study Days 210 and 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2008 (estimated)
  2. Study startOct 1999
  3. Primary completionSep 2004
  4. Study completionSep 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00693966
Sponsor's protocol ID
580299/005
Status last verified
Sep 2016
First submitted
5 Jun 2008
Last updated
16 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.

    PubMed 19221517

  • Giannini SL, Hanon E, Moris P, Van Mechelen M, Morel S, Dessy F, Fourneau MA, Colau B, Suzich J, Losonksy G, Martin MT, Dubin G, Wettendorff MA. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine. 2006 Aug 14;24(33-34):5937-49. doi: 10.1016/j.vaccine.2006.06.005. Epub 2006 Jun 19.

    PubMed 16828940

  • Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

    PubMed 18845199

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1), MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2) and MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3) in people with Infections, Papillomavirus, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited adverse event rates (including injection site and systemic reactions) (time frame: For 7 days after each injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00693966, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.

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