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Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

Primary Purpose

Human Papilloma Virus, Cervical Cancer, Vulvar Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Octavalent HPV with 15 mcg IMX / AAHS
Octavalent HPV with 30 mcg IMX / AAHS
Octavalent HPV with 60 mcg IMX / AAHS
Octavalent HPV with 120 mcg IMX / AAHS
Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant is in good physical health
  • Participant has had a lifetime history of 0 to 4 sexual partners
  • Females between 18-to-24 years

Exclusion Criteria:

  • Participant has a history of abnormal Pap test
  • Participant has a history of positive test for HPV
  • Participant has a history of recent or ongoing alcohol or drug abuse
  • Participant is immunocompromised or has an autoimmune condition
  • Participant has received immunosuppressive therapy within a year of screening
  • Participant has previously received an HPV vaccine
  • Participant is pregnant
  • Participant has a history of external genital/vaginal warts
  • Participant is currently enrolled in a clinical trial
  • Participant has a history of a severe allergic reaction that required medical attention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Active Comparator

    Experimental

    Experimental

    Arm Label

    qHPV (GARDASIL™) - Phase A Control

    Octavalent HPV with 15 mcg IMX / AAHS

    Octavalent HPV with 30 mcg IMX / AAHS

    qHPV (GARDASIL™) - Phase B Control

    Octavalent HPV with 60 mcg IMX / AAHS

    Octavalent HPV with 120 mcg IMX / AAHS

    Arm Description

    Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A.

    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX.

    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX.

    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B.

    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX.

    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX.

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
    The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
    Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
    The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
    Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
    A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
    Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
    A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2009
    Last Updated
    February 2, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00851643
    Brief Title
    Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
    Official Title
    A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.
    Detailed Description
    The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Papilloma Virus, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    158 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    qHPV (GARDASIL™) - Phase A Control
    Arm Type
    Active Comparator
    Arm Description
    Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A.
    Arm Title
    Octavalent HPV with 15 mcg IMX / AAHS
    Arm Type
    Experimental
    Arm Description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX.
    Arm Title
    Octavalent HPV with 30 mcg IMX / AAHS
    Arm Type
    Experimental
    Arm Description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX.
    Arm Title
    qHPV (GARDASIL™) - Phase B Control
    Arm Type
    Active Comparator
    Arm Description
    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B.
    Arm Title
    Octavalent HPV with 60 mcg IMX / AAHS
    Arm Type
    Experimental
    Arm Description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX.
    Arm Title
    Octavalent HPV with 120 mcg IMX / AAHS
    Arm Type
    Experimental
    Arm Description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX.
    Intervention Type
    Biological
    Intervention Name(s)
    Octavalent HPV with 15 mcg IMX / AAHS
    Other Intervention Name(s)
    V502
    Intervention Description
    0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
    Intervention Type
    Biological
    Intervention Name(s)
    Octavalent HPV with 30 mcg IMX / AAHS
    Other Intervention Name(s)
    V502
    Intervention Description
    0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
    Intervention Type
    Biological
    Intervention Name(s)
    Octavalent HPV with 60 mcg IMX / AAHS
    Other Intervention Name(s)
    V502
    Intervention Description
    0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
    Intervention Type
    Biological
    Intervention Name(s)
    Octavalent HPV with 120 mcg IMX / AAHS
    Other Intervention Name(s)
    V502
    Intervention Description
    0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
    Other Intervention Name(s)
    V502-002
    Intervention Description
    0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
    Description
    The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
    Time Frame
    4 weeks postdose 3 (Phase A)
    Title
    Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
    Description
    The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
    Time Frame
    4 weeks postdose 3 (Phase B)
    Title
    Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
    Description
    A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
    Time Frame
    4 weeks postdose 3 (Phase A)
    Title
    Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
    Description
    A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
    Time Frame
    4 weeks postdose 3 (Phase B)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participant is in good physical health Participant has had a lifetime history of 0 to 4 sexual partners Females between 18-to-24 years Exclusion Criteria: Participant has a history of abnormal Pap test Participant has a history of positive test for HPV Participant has a history of recent or ongoing alcohol or drug abuse Participant is immunocompromised or has an autoimmune condition Participant has received immunosuppressive therapy within a year of screening Participant has previously received an HPV vaccine Participant is pregnant Participant has a history of external genital/vaginal warts Participant is currently enrolled in a clinical trial Participant has a history of a severe allergic reaction that required medical attention
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

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