The HPV vaccine that men can also receive is coming! It can be called the "light of domestic HPV vaccine"

The phase III.
clinical study of recombinant nine-valent human papillomavirus (HPV11/16/18/31/33/45/52/58) vaccine for male indications independently developed by Beijing Connaught Guard Biotechnology Co.
, Ltd.
was officially launched, and the first subject was successfully enrolled in the Xing'an County Center for Disease Control and Prevention in Guangxi Zhuang Autonomous Region on December 18
, 2022.

Figure 1 Phase III.
clinical launch ceremony of nine-valent HPV vaccine (male indication) (Source: Company official website)

It is understood that after the successful phase III clinical trial of the nine-valent HPV vaccine (male indication), Connaught Guard's nine-valent HPV vaccine will seek the regulatory standards for male target population vaccination, and is expected to become the first domestic nine-valent HPV vaccine product that can be used for male population vaccination, which can be called the "light of domestic HPV vaccine"
.

Human papillomavirus (HPV) is a DNA virus that predisposes to human epidermis and mucosal squamous epithelial cells, which are rarely protected
by virus-specific antibodies.
More than 4/5 of sexually active people may be infected with HPV, and persistent HPV infection can lead to squamous epithelial cell lesions and even cancer
.
Clinically, persistent HPV infection is not only the main cause of cervical cancer, vulvar cancer and vaginal cancer in women, but also causes male and female diseases such as genital warts, cancer and head and neck cancer, and can also cause male infertility
.

For these reasons, the HPV vaccine has made great achievements in protecting women's health, and WHO has issued guidance that men be included in the target population of HPV vaccination after meeting the vaccination needs of the main target population
.
Since then, the FDA has approved the nine-valent HPV vaccine for the prevention of and oropharyngeal cancer in men, as well as other head and neck cancers
.
Australia, the United States, Canada and other countries have carried out male HPV vaccination, and the incidence of male HPV infection and related diseases has decreased
.
It can be seen that the benefits of HPV vaccination in men are obvious, and it is a trend
to increase the HPV vaccination rate of men.

Vaccination is a very effective preventive measure against the harm caused by HPV infection, and 65 countries around the world have adopted it as a routine immunization program
.
Quadrivalent and nine-valent HPV vaccines have been approved for male injection, and have a good immune response in men, which can directly protect men
.
The effectiveness rate of HPV vaccine for preventing HPV16-related anogenital infection in men was 46.
9%, the effective rate of preventing persistent oral HPV infection was 88%, and the effectiveness rate of preventing grade 2 and grade 3 of intraepithelial neoplasia was 61.
9% and 46.
8%, respectively [1], which showed that HPV vaccine could effectively prevent HPV infection and mucosal damage
in men.

According to relevant statistics, the global male group (9-45 years old) suitable for HPV vaccine in 2020 will be 2.
151 billion, and it is expected that the global male group suitable for HPV vaccine will reach 2.
228 billion in
2050.
In China, the number of men suitable for HPV vaccination in China in 2020 was 344 million, and about 980 million doses of vaccines were needed to reach the goal of full vaccination [2].

However, the fact is that up to now, the HPV vaccine marketed in China cannot be used for male vaccination of appropriate age, and the nine-valent HPV vaccine of Connaught Guard is the first variety in China to obtain the clinical approval certificate for male
indications.
The clinical study of the nine-valent HPV vaccine (for male indications) aims to verify the efficacy of the vaccine for the prevention of persistent infection caused by HPV6/11/16/18/31/33/45/52/58 and male genital warts, anal intraepithelial neoplasia, anal cancer, penile/perineum/perianal intraepithelial neoplasia and penile/perineum/perianal cancer
.

The clinical trial of nine-valent HPV vaccine (male indication) was approved by clinical acquiescence in December 2020, and the phase I clinical trial was launched in August 2021, and all follow-up
of the phase I clinical trial has been completed.
The trial results show that the vaccine also has a good safety profile in the male population, and the trial data support the continuation of phase III clinical trials
.
Previously, the nine-valent HPV vaccine has completed phase I/II clinical trials in Chinese women aged 20-45 years and is undergoing phase III clinical trials
.

Phase I/II clinical trials in women have shown that the vaccine has a good safety profile and immunogenicity
.
At the same time, the optimal prescription and immune dose ratio was determined through the phase II clinical trial of female indication, which provided a scientific basis
for the prescription and immunization dose of the phase III clinical trial of nine-valent HPV vaccine (male indication).

The phase III clinical trial for male indications will recruit 9,000 male subjects aged 18-45 years, including 7,800 heterosexual men
.
Connaught Guard said that it will strictly abide by GCP norms and carefully organize and implement clinical trials in order to obtain safe and effective clinical data and benefit the majority of male groups
as soon as possible.