Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
February 2, 2016 updated by: Merck Sharp & Dohme LLC
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)
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
158
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Names:
|
|
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.
|
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Names:
|
|
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.
|
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Names:
|
|
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.
|
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Names:
|
|
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.
|
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Names:
|
|
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.
|
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks postdose 3 (Phase A)
|
|
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.
|
4 weeks postdose 3 (Phase B)
|
|
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 weeks postdose 3 (Phase A)
|
|
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.
|
4 weeks postdose 3 (Phase B)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
November 1, 2009
Study Registration Dates
First Submitted
February 24, 2009
First Submitted That Met QC Criteria
February 24, 2009
First Posted (ESTIMATE)
February 26, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- DNA Virus Infections
- Skin Diseases, Infectious
- Warts
- Papillomavirus Infections
- Skin Diseases, Viral
- Tumor Virus Infections
- Vaginal Diseases
- Neoplasms, Squamous Cell
- Vulvar Diseases
- Vulvar Neoplasms
- Vaginal Neoplasms
- Papilloma
- Condylomata Acuminata
Other Study ID Numbers
- V502-002
- 2009_552
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.