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Merck will also conduct clinical trials in both males and females to evaluate the efficacy of a single dose of their current human papillomavirus vaccine compared with the approved 3-dose regimen.
Merck plans to initiate clinical development of a new investigational multi-valent human papillomavirus (HPV) vaccine for broader protection against multiple HPV types, according to a press release from the company. Further, Merck will also conduct clinical trials in both males and females to evaluate the efficacy of a single-dose of their HPV 9-valent recombinant vaccine, Gardasil 9, compared to the approved 3-dose regimen.
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“Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” Eliav Barr, MD, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in the press release. “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.”
According to the press release, investigators continue to work on the development of Gardasil and Gardasil 9 to develop new candidates to extend the potential coverage against broader HPV types. The newest addition to the pipeline includes the company’s proprietary virus-like particle technology to expand the HPV type coverage, which will include African and Asian individuals and those of African and Asian descent. The first-in-human studies are scheduled to start in the fourth quarter of 2024, according to the press release.
Additionally, Merck will be conducting 2 prospective studies for females and males ages 16 to 26 years. This comes in response to scientific leaders' requests for more clinical data about the alternative dosing regimens for Gardasil 9, according to the press release.
The trials will be randomized, multi-year, and double-blinded to evaluate the long term and short-term efficacy and immunogenicity of a single dose of the vaccine compared with the current dosing schedule. The clinical trials will determine whether a single dose is comparable to the 3-dose regimen in the long term while also satisfying the high standards by regulatory authorities. The clinical trial is expected to start enrolling in the fourth quarter of 2024 as well, according to the press release.
Furthermore, Merck has also addressed the global demand and broader access for Gardasil and Gardasil 9 and made significant investments in manufacturing to increase the supply, according to the press release. In 2019, the company expanded the manufacturing capacity and, from 2017 to 2020, the result of expansion nearly doubled the supply, doubling again between 2020 and 2024. In 2025, the company expects the supply to meet the anticipated demand, and it will continue to expand in the future to further meet demands.
Gardasil 9 is indicated for use in females 9 through 45 years of age to prevent cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers that are caused by HPV Types 16, 28, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by 6, 11, 16, 18, 31,31, 45, 52, and 58; and genital warts caused by 6 and 11, according to the press release. It is also indicated for males aged 9 through 45 years in the same indications. It was approved for oropharyngeal and head and neck cancer under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.
Continued approval for the indication could be contingent upon verification and clinical benefits in confirmatory trials that are currently ongoing, according to the press release.
Reference
Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for Gardasil 9. News release. Merck. March 13, 2024. Accessed March 19, 2024. https://www.merck.com/news/merck-announces-plans-to-conduct-clinical-trials-of-a-novel-investigational-multi-valent-human-papillomavirus-hpv-vaccine-and-single-dose-regimen-for-gardasil-9/
