March 13 (Reuters) - Merck & Co ( MRK ) said on
Wednesday it plans to conduct clinical trials testing its human
papillomavirus (HPV) vaccine Gardasil 9 to evaluate the efficacy
and safety of a single-dose regimen compared to the approved
three-dose regimen.
The company said it plans to conduct two separate trials
testing Gardasil 9 in men and women 16-26 years old to examine
whether a single dose of the vaccine provides comparable
long-term protection when compared with the approved three-dose
regimen.
The large, multi-year trials are expected to start
enrollment in the fourth quarter of 2024, according to Merck ( MRK ).
The drugmaker also plans to begin human trials for an
experimental HPV vaccine in the fourth quarter that is designed
to offer broader protection by targeting multiple HPV types.
The U.S. Food and Drug Administration first approved
Gardasil 9 in 2014 to prevent certain cancers, including
cervical, vulvar, vaginal and anal cancers, and diseases caused
by nine variants of HPV.
Gardasil 9 is now approved for use in women and men aged 9
through 45 years.
HPV causes about 36,000 cancer cases in both men and women
every year in the United States, according to government data.