Phase 1
N=150
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Human Papilloma Virus · Cervical Cancer · Vulvar Cancer · Vaginal Cancer · Genital Warts
Bottom Line
View on ClinicalTrials.gov: NCT00851643 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A — 1273.3; 2203.0; 4784.7; 1991.6 mMU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 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 (Biological); Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A |
1273.3; 2203.0; 4784.7; 1991.6; 2564.3; 3921.6 | — |
| PRIMARY Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B |
2350.9; 6006.0; 4484.8; 3762.2; 6514.2; 6609.3 | — |
| PRIMARY Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A |
11; 21; 22; 11; 21; 22 | — |
| PRIMARY Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B |
10; 19; 23; 10; 19; 23 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00851643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.