Merck & Co. has unveiled plans to start clinical trials assessing the effectiveness and safety of a single-dose regimen of its human papillomavirus (HPV) vaccine, Gardasil 9. This move aims to determine if a single dose can offer similar long-term protection as the current three-dose series. The trials are set to be randomized, double-blind, and will occur over multiple years, involving participants aged 16-26 years, both male and female.
Enrollment for these trials is slated to begin in the fourth quarter of 2024. This development responds to scientific calls for more clinical data regarding alternative dosing patterns for Gardasil 9. The vaccine is already approved for use in people aged 9 to 45 years to prevent several cancers linked to nine HPV types, including cervical and anal cancers, among others.
Merck's decision to conduct these trials underscores their commitment to potentially simplifying vaccination practices without compromising safety or efficacy. Gardasil 9's safety profile notes that it is not recommended for individuals with yeast hypersensitivity or those who had adverse reactions to a previous dose. Reuters highlighted the anticipation around this trial, indicating a broader interest in more adaptable HPV vaccination strategies.