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

Cervical Cancer Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851643
• Other study ID #: V502-002
• Secondary ID: 2009_552
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2009
• Last updated: February 2, 2016
• Start date: April 2006
• Est. completion date: November 2009

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Genital Warts
• Human Papilloma Virus
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Biological:
• Octavalent HPV with 15 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
• Octavalent HPV with 30 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
• Octavalent HPV with 60 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
• Octavalent HPV with 120 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
• Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for 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)	No
Primary	Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for 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)	No
Primary	Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During 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)	No
Primary	Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During 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)	No