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)
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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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)
Australia: National Health and Medical Research Council