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

Phase 1

Completed

• Conditions: Cervical Cancer; Vaginal Cancer; Vulvar Cancer; Genital Warts; Human Papilloma Virus
• Interventions: 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

• Registration Number: NCT00851643
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-12
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-26
• Study Completion: 2009-11
• Results First Submitted: 2011-02-10
• Results First Submitted QC: 2011-05-20
• Results First Posted: 2011-06-21
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 158

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Octavalent HPV with 15 mcg IMX / AAHS	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.
Octavalent HPV with 30 mcg IMX / AAHS	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.
Octavalent HPV with 60 mcg IMX / AAHS	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.
Octavalent HPV with 120 mcg IMX / AAHS	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A	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.
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B	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.
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A	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.
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B	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.