Merck Inc, announces plans to conduct clinical trials of a novel investigational multi-valent human papillomavirus (HPV) vaccine and single-dose regimen for Gardasil 9

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of Gardasil 9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

.“Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “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.”

In the U.S., Gardasil 9 is indicated for use in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. Gardasil 9 is also indicated for use in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory trial is ongoing.

Gardasil 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Multivalent HPV vaccine research: Merck vaccine researchers continue to build on the development of Gardasil and Gardasil 9 to identify new candidates with the potential to extend protection against a broader array of HPV types. The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage. This includes several types known to have more impact in African and Asian populations and individuals of African and Asian descent. First-in-human studies (Phase 1) are scheduled to start in the fourth quarter of 2024.

Assessing the potential efficacy and durability of a single dose regimen of GardasilL 9; In response to calls from scientific leaders for more clinical data concerning alternative dosing regimens for Gardasil 9, Merck, pending regulatory input, plans to conduct two prospective clinical trials, one in females (16-26 years old) and one in males (ages 16-26 years old).

These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of Gardasil 9 versus the currently approved three-dose regimen. The goal of these large, randomized trials is to generate data that clearly determines whether or not a single dose of Gardasil 9 provides comparable long-term protection to the approved three-dose regimen, while also satisfying the high standards required by regulatory authorities. The clinical trials are anticipated to start enrolling participants in the fourth quarter of 2024.