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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851643
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : June 21, 2011
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Biological: Octavalent HPV with 15 mcg IMX / AAHS Biological: Octavalent HPV with 30 mcg IMX / AAHS Biological: Octavalent HPV with 60 mcg IMX / AAHS Biological: Octavalent HPV with 120 mcg IMX / AAHS Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : April 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: qHPV (GARDASIL™) - Phase A Control
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.
Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Name: V502-002

Experimental: Octavalent HPV with 15 mcg IMX / AAHS
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.
Biological: Octavalent HPV with 15 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Name: V502

Experimental: Octavalent HPV with 30 mcg IMX / AAHS
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.
Biological: Octavalent HPV with 30 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Name: V502

Active Comparator: qHPV (GARDASIL™) - Phase B Control
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.
Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Name: V502-002

Experimental: Octavalent HPV with 60 mcg IMX / AAHS
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.
Biological: Octavalent HPV with 60 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Name: V502

Experimental: Octavalent HPV with 120 mcg IMX / AAHS
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.
Biological: Octavalent HPV with 120 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Name: V502




Primary Outcome Measures :
  1. Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A [ Time Frame: 4 weeks postdose 3 (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.

  2. Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B [ Time Frame: 4 weeks postdose 3 (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.

  3. Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A [ Time Frame: 4 weeks postdose 3 (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.

  4. Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B [ Time Frame: 4 weeks postdose 3 (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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851643


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00851643    
Other Study ID Numbers: V502-002
2009_552
First Posted: February 26, 2009    Key Record Dates
Results First Posted: June 21, 2011
Last Update Posted: February 3, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Condylomata Acuminata
Papilloma
Vulvar Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vulvar Diseases
Vaginal Diseases
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs