9-Valent human papillomavirus vaccine: a review of the clinical development program

ABSTRACT

Introduction: The 9-valent human papillomavirus (9vHPV) vaccine covers the same HPV types (6/11/16/18) as the quadrivalent HPV (qHPV) vaccine and 5 additional cancer-causing types (31/33/45/52/58). Epidemiological studies indicate that the 9vHPV vaccine could prevent approximately 90% of cervical cancers, 70–85% of high-grade cervical dysplasia (precancers), 85–95% of HPV-related vulvar, vaginal, and anal cancers, and 90% of genital warts.

Areas covered: Study design features and key findings from the 9vHPV vaccine clinical development program are reviewed. In particular, 9vHPV vaccine efficacy was established in a Phase III study in young women age 16–26 years. Efficacy results in young women were extrapolated to pre- and young adolescent girls and boys and young men by immunological bridging (i.e., demonstration of non-inferior immunogenicity in these groups versus young women).

Expert commentary: The development of the 9vHPV vaccine is the outcome of 20 years of continuous clinical research. Broad vaccination programs could help substantially decrease the incidence of HPV-related disease.

KEYWORDS:

• Cervical cancer
• genital warts
• human papillomavirus
• vaccine
• 9-valent

Acknowledgments

The authors thank Barbara Kuter and Gonzalo Perez (Merck & Co., Inc., Kenilworth, NJ, USA) for their comments.

Declaration of interest

A Luxembourg and E Moeller are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

Funding for the 9vHPV vaccine studies was provided by Merck & Co., Inc., Kenilworth, NJ, USA. Two studies were funded by Sanofi Pasteur MSD, SNC, Lyon, France, a joint venture of Sanofi Pasteur, Lyon, France and Merck & Co., Inc., Kenilworth, NJ, USA. Editorial assistance for the preparation of this review was provided by Erin Bekes, PhD, of Complete Medical Communications, Hackensack, NJ. This assistance was funded by Merck & Co., Inc., Kenilworth, NJ, USA.