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Completed

NCT Number: NCT00851643

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

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.

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Key information

Conditions

Human Papilloma Virus Cervical Cancer Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genital Warts Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Virus Diseases Vulvar Cancer Vulvar Diseases Vulvar Neoplasms Warts

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octavalent HPV with 15 mcg IMX / AAHS

Biological

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

Other names: V502

Octavalent HPV with 30 mcg IMX / AAHS

Biological

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

Other names: V502

Octavalent HPV with 60 mcg IMX / AAHS

Biological

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

Other names: V502

Octavalent HPV with 120 mcg IMX / AAHS

Biological

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

Other names: V502

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

Biological

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

Other names: V502-002

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Feb 26, 2009
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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