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

NCT00693966 | Completed Phase 2

• 1 other identifier: 580299/005
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Infections, Papillomavirus

Keywords

HPV, Vaccine

Outcome Measures

Primary Outcomes (6)

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

  For 7 days after each injection

• Unsolicited adverse event rates

  For 30 days after each injection

• Serious adverse event rates

  From first injection through 30 days after last injection

• Laboratory assessments (Biochemistry and Hematology parameters)

  Study Days 0, 30 and 210

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

  At the time of injection and 30 minutes after the injection

• Serum ELISA titers against HPV-16 and HPV-18

  30 days after the third injection

Secondary Outcomes (5)

• Serum ELISA titers against HPV-16 and HPV-18

  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

  Study Days 0, 60, 210 and 360

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

  Study Days 0, 60, 210, and 360

• HPV-16 and HPV-18 ELISA and inhibitory ELISA

  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

  At Study Days 210 and 360

Study Arms (4)

Group A

EXPERIMENTAL

Formulation 1 of the vaccine (MEDI-517 HPV-16/18 VLP AS04 vaccine)

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

Group B

EXPERIMENTAL

Formulation 2 of the vaccine

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

Group C

EXPERIMENTAL

Formulation 3 of the vaccine

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

Group D

EXPERIMENTAL

Formulation 4 of the vaccine \[with Al(OH)3\]

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

Interventions

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

IM injection

Group A

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

IM injection

Group B

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

IM injection

Group C

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

IM injection

Also known as: 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)

Group D

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (3)

• 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.

  PMID: 19221517 BACKGROUND

• 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.

  PMID: 16828940 BACKGROUND

• 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.

  PMID: 18845199 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: October 1, 1999
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share