Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
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)
2 other identifiers
interventional
158
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2006
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 26, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
June 21, 2011
CompletedFebruary 3, 2016
February 1, 2016
1.7 years
February 24, 2009
February 10, 2011
February 2, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
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.
4 weeks postdose 3 (Phase A)
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.
4 weeks postdose 3 (Phase B)
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.
4 weeks postdose 3 (Phase A)
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.
4 weeks postdose 3 (Phase B)
Study Arms (6)
qHPV (GARDASIL™) - Phase A Control
ACTIVE COMPARATORQuadrivalent 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 HPV with 15 mcg IMX / AAHS
EXPERIMENTALOctavalent 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 HPV with 30 mcg IMX / AAHS
EXPERIMENTALOctavalent 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.
qHPV (GARDASIL™) - Phase B Control
ACTIVE COMPARATORQuadrivalent 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 HPV with 60 mcg IMX / AAHS
EXPERIMENTALOctavalent 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 HPV with 120 mcg IMX / AAHS
EXPERIMENTALOctavalent 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.
Interventions
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Eligibility Criteria
You may qualify if:
- Participant is in good physical health
- Participant has had a lifetime history of 0 to 4 sexual partners
- Females between 18-to-24 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President,Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 26, 2009
Study Start
April 1, 2006
Primary Completion
December 1, 2007
Study Completion
November 1, 2009
Last Updated
February 3, 2016
Results First Posted
June 21, 2011
Record last verified: 2016-02