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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

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

Treatments: Biological: Octavalent HPV with 60 mcg IMX / AAHS; Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™); Biological: Octavalent HPV with 120 mcg IMX / AAHS; Biological: Octavalent HPV with 30 mcg IMX / AAHS; Biological: Octavalent HPV with 15 mcg IMX / AAHS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851643

V502-002

2009_552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 6 patient groups

qHPV (GARDASIL™) - Phase A Control

Active Comparator group

Description:

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.

Treatment:

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

Octavalent HPV with 15 mcg IMX / AAHS

Experimental group

Description:

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.

Treatment:

Biological: Octavalent HPV with 15 mcg IMX / AAHS

Octavalent HPV with 30 mcg IMX / AAHS

Experimental group

Description:

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.

Treatment:

Biological: Octavalent HPV with 30 mcg IMX / AAHS

qHPV (GARDASIL™) - Phase B Control

Active Comparator group

Description:

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.

Treatment:

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

Octavalent HPV with 60 mcg IMX / AAHS

Experimental group

Description:

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.

Treatment:

Biological: Octavalent HPV with 60 mcg IMX / AAHS

Octavalent HPV with 120 mcg IMX / AAHS

Experimental group

Description:

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.

Treatment:

Biological: Octavalent HPV with 120 mcg IMX / AAHS