MSD, commercialize adult male oral HPV prevention vaccine

The MFDS approved on the 20th, 250 national subjects with multinational clinical trials

The current HPV vaccine 'Gardasil 9' applies only to those aged 9 to 26, In clinical trials, age 20-45

Gardasil 9, MSD

MSD conducts vaccine clinical trials to prevent oral HPV (human papillomavirus) infection in adult men.

 

MSD has already introduced vaccines to prevent human papillomavirus through 'Gardasil · Gardasil9', but there are no indications for oral HPV prevention in adult men.

 

The MFDS approved IND for phase III of an HPV vaccine (V503) submitted by MSD in Korea on the 20th.

 

This clinical trial is aimed at the efficacy and immunity of the 9vHPV vaccine, a multivalent L1 virus-like particle vaccine in terms of HPV 16, 18, 31, 33, 45, 52, and 58 oral infections in adult males aged 20 to 45 years.

 

This is a phase III, international, multicenter, randomized, double-blind, placebo-controlled clinical trial that evaluates originality and safety.

 

The total number of subjects is 6000, and the number of domestic subjects is 250.

 

MSD plans to conduct this clinical trial from December this year to January 2025.

 

In Korea, Eunpyeong St.

 

Mary's Hospital, Severance Hospital, Korea University Guro Hospital, HUMC-Kangnam Hospital, and Korea University Ansan Hospital participate.

 

Human papillomavirus (HPV) causes papillomas in humans in the case of a virus that is infected through the skin or subcutaneous of an animal.

 

It also causes cervical burden and testicular cancer.

 

The most famous HPV vaccine in the world is MSD's Gardasil.

 

The recently released Gardasil 9 prevents nine types of human papillomavirus and can be inoculated to women aged 9 to 26 and men aged 9 to 26.

 

Gardasil is mainly used to prevent cervical disease in women, genital and anal diseases in men.

 

However, HPV virus is also known to be the cause of infiltration into the oral cavity and larynx cancer mainly due to sexual intercourse.

 

According to the HIRA, 2629 men were treated for oral cancer in 2018, an increase of about 33% compared to 2014.

 

The exact cause of oral cancer is unknown, but smoking and drinking are the biggest risk factors, and are sometimes caused by the HPV virus.

 

This clinical trial primarily evaluates vaccine efficacy against oral infections involving HPV 16, 18, 31, 33, 45, 52, and 58 that lasts more than 6 months, and secondly, it is a test to check the serum antibody titers, adverse reactions, etc.

 

MSD's Gardasil 9 had a domestic sales of ₩40.5 billion, based on IQVIA last year, and is superior in the domestic HPV vaccine market.

 

If indications are added, it is expected to have a significant impact on market expansion and sales growth.