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

NCT ID: NCT00851643

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-11-30

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.

Conditions

Human Papilloma Virus; Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)

Intervention Type: BIOLOGICAL

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

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.

Group Type: EXPERIMENTAL

Octavalent HPV with 15 mcg IMX / AAHS

Intervention Type: BIOLOGICAL

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

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.

Group Type: EXPERIMENTAL

Octavalent HPV with 30 mcg IMX / AAHS

Intervention Type: BIOLOGICAL

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

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.

Group Type: ACTIVE_COMPARATOR

Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)

Intervention Type: BIOLOGICAL

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

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.

Group Type: EXPERIMENTAL

Octavalent HPV with 60 mcg IMX / AAHS

Intervention Type: BIOLOGICAL

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

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.

Group Type: EXPERIMENTAL

Octavalent HPV with 120 mcg IMX / AAHS

Intervention Type: BIOLOGICAL

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Interventions

Octavalent HPV with 15 mcg IMX / AAHS

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Octavalent HPV with 30 mcg IMX / AAHS

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Octavalent HPV with 60 mcg IMX / AAHS

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Octavalent HPV with 120 mcg IMX / AAHS

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)

0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Intervention Type: BIOLOGICAL

Other Intervention Names

V502; V502; V502; V502; V502-002

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2009_552

Identifier Type: -

Identifier Source: secondary_id

V502-002

Identifier Type: -

Identifier Source: org_study_id