Noninferiority of antibody response to human papillomavirus type 16 in subjects vaccinated with monovalent and quadrivalent L1 virus-like particle vaccines

Abstract

The incorporation of multiple antigens into a single human papillomavirus (HPV) vaccine may induce immune interference. To evaluate whether interference occurs when HPV type 16 (HPV16) virus-like particles are combined in a multivalent vaccine, we conducted a study to evaluate anti-HPV16 responses among subjects receiving three-dose regimens of either a monovalent HPV16 vaccine or a quadrivalent HPV (types 6, 11, 16, and 18) vaccine.

FIG. 1.

Schematic of substudies 011 and 012 in the context of the larger efficacy study 013. HBV, hepatitis B virus.

FIG. 2.

Reverse cumulative distributions of anti-HPV16 levels in HPV vaccination groups at month 7 as determined by cLIA. The per-protocol immunogenicity population included all subjects who were not general protocol violators, received all three vaccinations within acceptable day ranges, were seronegative for HPV16 at day 1 and PCR negative from day 1 through month 7, and had a month 7 serum sample collected within an acceptable day range. The vertical line at 20 mMU/ml represents the seroconversion cutoff value for anti-HPV16. n, number of subjects contributing to the analysis.