USA— Merck, an American multinational pharmaceutical firm based in Rahway, novel Jersey, has announced plans to begin clinical development of a novel investigational multivalent HPV vaccination that will provide broader protection against various HPV strains.

The corporation also intends to perform clinical trials in both males and females to assess the efficacy and safety of a single dose of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant) versus the approved three-dose regimen.

This statement was made at the EUROGIN 2024 HPV Congress, which will take place at the Waterfront Congress Centre in Stockholm from March 13 to 16.

EUROGIN is the world’s premier international congress on HPV infections and related malignancies, with a focus on prevention and diagnosis.

This event seeks to translate scientific and evidence-based research into clinical practice through a high-quality and creative program designed by great worldwide leaders.

The conference provides an opportunity to exchange information and expertise with peers from around the world.

For More than a decade of evidence demonstrate that the 9-valent HPV vaccine is both safe and effective in providing long-term protection.

The 9-valent HPV vaccine gives around 98% protection against cervical cancer and has been shown to be 90% effective against other HPV-related illnesses, precancerous lesions, including genital warts.

Routine immunization is advised for those aged 11 to 12, but the series can begin at age 9.

Merck will use its proprietary virus-like particle (VLP) technology to investigate additional VLPs that will expand HPV coverage, including multiple types of the virus that are more prevalent in African and Asian populations, as well as those of African and Asian descent.

Merck said in their statement that phase I studies of the experimental vaccine will begin in the fourth quarter of 2024.

Merck also claimed that it will conduct two prospective randomized, double-blind, multi-year clinical trials to assess the short- and long-term efficacy and immunogenicity of a single dose of Gardasil 9. One trial will recruit females aged 16-26 years, while the other will enroll boys aged 16-26.

Investigators are looking for data that will show whether a single dosage of the vaccine will provide comparable long-term protection to the approved three-dose schedule. These studies are scheduled to commence enrollment in the fourth quarter of 2024.

On his part, Eliav Barr, MD, senior vice president, head of worldwide clinical development, and chief medical officer at Merck Research Laboratories, stated that evidence continues to emerge demonstrating the relevance of Gardasil and Gardasil 9 to public health.

He went on to say that these major investments build on their leadership and, more crucially, have the potential to further reduce the worldwide burden of certain HPV-related malignancies and diseases.

Gardasil 9 is approved for females aged 9 to 45 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, as well as 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.

The vaccine has also been approved for use in males aged 9–45 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.

The FDA awarded Gardasil 9 expedited approval for oropharyngeal and head and neck cancer, with continued approval based on the verification and description of therapeutic benefit in an ongoing confirmatory study.

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