Merck Announces New Clinical Trial to Evaluate Single-Dose Regimen of GARDASIL 9 in Individuals Aged 16–26

On March 13, MSD announced plans to conduct a clinical trial for the 9-valent human papillomavirus (HPV) vaccine (Gardasil 9) to evaluate the short-term and long-term efficacy and immunogenicity of a single-dose regimen compared to the approved three-dose regimen in males and females aged 16-26. According to MSD, recruitment for the clinical trial is expected to begin in the fourth quarter of 2024.

Source: MSD official website

In addition, Merck vaccine researchers will continue to build on the development of GARDASIL and GARDASIL9 to identify new candidate vaccines that could expand protection against a broader range of HPV types. The latest candidate in this product line utilizes MSD’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs, broadening the coverage of HPV types. This includes several HPV types known to have a greater impact on populations in Africa and Asia, as well as individuals of African and Asian descent. The first-in-human study (Phase 1 clinical trial) is also planned to begin in the fourth quarter of 2024.

HPV Vaccine is the Strongest Driver of MSD's Performance; Gardasil/Gardasil 9 Revenue Reached $8.9 Billion in 2023, Increasing by 33% Year-over-Year (Excluding Foreign Exchange Impact).

To meet the growing global demand for HPV vaccines, MSD has made significant investments in manufacturing to help increase supply. Starting from 2019, production capacity was expanded by increasing output at existing facilities and constructing new ones. Between 2017 and 2020, supply nearly doubled, and it doubled again between 2020 and 2024. MSD expects to supply enough HPV vaccines to meet anticipated demand in 2025 and will continue to expand its supply capabilities in the future.

GARDASIL9 is a vaccine for females aged 9 to 45, preventing cervical cancer, vulvar cancer, vaginal cancer, anal cancer, oropharyngeal cancer, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; as well as precancerous lesions or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL9 is also approved for use in males aged 9 to 45. GARDASIL9 is indicated for the prevention of anal cancer, oropharyngeal cancer, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; 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 application for market approval for males in China has been accepted by the NMPA.

Based on the effectiveness in preventing HPV-related anogenital diseases, the indication for GARDASIL9 for oropharyngeal and head and neck cancers is under accelerated approval. The continuation of this indication's approval may depend on the verification and description of clinical benefit in confirmatory trials.

The complete vaccination schedule for GARDASIL9 includes:

For individuals aged 9-14 years, GARDASIL9 can be administered using either a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6-12 months after the first dose. If the second dose is given less than 5 months after the first dose, a third dose should be administered at least 4 months after the second dose. For the 3-dose schedule, GARDASIL9 should be administered at 0, 2, and 6 months.

For individuals aged 15-45, GARDASIL9 is administered in three doses at month 0, month 2, and month 6.

Reference: MSD official website

Editor: Baiji

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