Merck to test single-dose regimen of HPV vaccine Gardasil 9

By Thomson Reuters Mar 13, 2024 | 2:06 AM

(Reuters) – Merck & Co 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.

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.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shounak Dasgupta)