Merck Announces Clinical Trial Programs to Assess Novel Multi-Type HPV Vaccine, New Single-Dose Gardasil 9 Formulation
Clinical trials planned for the fourth quarter of 2024 will evaluate a new multi-valent vaccine to protect against multiple types of human papillomavirus, and to analyze the efficacy and safety of a single-dose of Gardasil 9.
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Merck has announced multiple clinical trial programs seeking to develop a new multi-valent vaccine that will protect against multiple types of human papillomavirus (HPV), as well as trials seeking assess the efficacy and safety of a single-dose of Gardasil 9 (HPV 9-valent, recombinant) compared to the currently approved three-dose regimen in protecting against HPV.1
More than a decade of data show that the 9-valent HPV vaccine is safe and effective in providing long-lasting protection. The 9-valent HPV vaccine provides approximately 98% protection against cervical cancer and has been found approximately 90% effective protecting against other diseases, precancerous lesions, and genital warts associated with HPV. Routine vaccination is recommended for individuals aged 11 to 12 years, but the series can be started at age 9.2
“Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories said in a 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.”1
For the development of the novel multi-valent vaccine, Merck announced that it is seeking to employ its proprietary virus-like particle (VLP) technology to investigate additional VLPs that will expand HPV coverage, including multiple types of the virus that have a greater effect on African and Asian populations and those of African and Asian descent. Phase I trials of the investigational vaccine are scheduled to begin in the fourth quarter of 2024, according to Merck.
Merck also stated that it will launch a pair of prospective randomized, double-blind, multi-year clinical trials to evaluate the short- and long-term efficacy and immunogenicity of a single-dose of Gardasil 9. One of the trials will enroll females aged 16-26 years and one will enroll males aged 16-26 years. Investigators are seeking to collect data that will illustrate whether a single dose of the vaccine can offer similar long-term protection to the approved three-dose regimen. These trials are expected to begin enrollment during the fourth quarter of 2024.
Gardasil 9 has been approved for females from 9 to 45 years of age to prevent 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 11.1
The vaccine has also been approved for use in males aged 9 through 45 years to prevent 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 11.1
The FDA granted Gardasil 9 with accelerated approval for the oropharyngeal and head and neck cancer indication, with continued approval contingent on verification and description of clinical benefit in an ongoing confirmatory trial.
References
1. Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL® 9. Merck. News release. March 13, 2024. Accessed March 13, 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/
2. Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus vaccination-updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2016;65:1405-1408. doi: 10.15585/mmwr.mm6549a5.
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