Merck to Start Trials of New HPV Vaccine and Single-Dose Gardasil Shot

Merck

Pictured: Merck & Co. headquarters in Silicon Valley iStock/Sundry Photography

Merck has unveiled plans to ramp up its human papillomavirus portfolio with a new vaccine, starting a trial launch in the fourth quarter of this year, the company announced Wednesday at the EUROGIN 2024 HPV Congress.

The new multi-valent HPV vaccine aims to give broader protection against multiple types of the viral infection.

According to Merck, the company has been working to identify new candidates to protect against a more comprehensive array of HPV, with its latest addition to the pipeline using its virus-like particle technology to incorporate more particles and expand coverage. This includes several types that impact Asian and African populations and those of African and Asian descent.

Merck is also planning to conduct trials in male and female patients to evaluate the safety and efficacy of a single-dose regimen of Gardasil 9 versus the approved three-dose regimen.

“Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” Merck CMO Eliav Barr said in a statement. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.”

Merck is planning for two separate clinical trials in males and females between 16 and 26 years of age to examine a single dose’s short- and long-term efficacy and immunogenicity. The trials are expected to enroll patients in the fourth quarter of 2024.

The vaccine is currently cleared for females aged nine through 45 years to prevent several types of cancers caused by HPV types, including cervical, vulvar, oropharyngeal, and head and neck cancers.

Gardasil and Gardasil 9 are key earners for Merck, as the vaccine pulled in over $8.8 billion in revenue in 2023, a 29% increase from 2022.

However, Merck is not stopping with just HPV vaccines. The company is looking to challenge Pfizer in the pneumococcal vaccine arena as the FDA granted priority review for a Biologics License Application for V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine, with a PDUFA date set for June 17, 2024.

Merck is also working with Moderna to create a combination of its cancer drug Keytruda and an mRNA vaccine, which has shown improvement in melanoma at the three-year mark.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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