Domestic cervical cancer vaccine curve overtaking 5.5 years of follow -up protection rate 100%

The first domestic cervical cancer vaccine curve overtaking 5.5 years follow -up results showed that the protection rate was 100%

Source: Sai Bailan

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Recently, the latest research team of 17 research teams, including Professor Zhao Fanghui, Cancer Hospital of the Chinese Academy of Medical Sciences, and Professor Wu Ting University of Xiamen University, the first research team of the first domestic second-priced HPV Human Papilloma Virus, Human Popular Tumor Virus) vaccine (Xin Kening) 5.5 years of follow -up results.

The results of the study show that in the population of women aged 18 to 45, the protection rate of HPV16/18 related high -level genital carcinoma prematures of HPV16/18 is as high as 100%, and high -level antibodies can be induced.

Screenshot of the article

In the conformity of the plan, Xin Kening's high-level genital lesions related to HPV16/18 infections are 100%(95%confident interval: 67.2%-100.0%); The protection rate for 6 months was 97.3%(95%confident interval: 89.9%-99.7%).

The two -valent HPV vaccine has the effect of protecting the pre -lesion and continuous infection of HPV16/18 related reproductive tract cancer

The two -valent HPV vaccine is effective in the protection of pre -infections and continuous infection in HPV16/18 of people in different ages

In the 66 -month follow -up analysis, the Xin Kening vaccine can effectively induce subjects to produce high and long -term HPV 16 and type 18 neutralizes and IgG antibodies, showing good immune persistence.

The specific neutral neutralization of antibodies induced among different ages after a dose of two -valent HPV vaccine

(The numbers above the columnic diagram represent the serum positive rate of follow -up of each time in time; GMC, antibody geometric average concentration)

The follow -up time of this study exceeded other domestic HPV vaccines. As the first domestic HPV vaccine, Xin Koning's protection effect has been verified for a long time.

Protection and adverse reactions are the most concerned on the target group when vaccinated HPV vaccines.

Cervical cancer is mainly caused by continuous infection of high -risk HPVs. About 99.7%of patients with cervical cancer can detect high -risk HPVs. Among them, the HPV16/18 two types are extremely dangerous. 84.5%of cervical squamous carcinoma in China is caused by these two types. Globally, about 70%of cervical cancer is caused by these two types of subtypes.

Inoculation of HPV vaccine is an effective means to prevent cervical cancer.

Measuring a HPV vaccine is generally believed that the price and vaccine protection rate is an important reference indicator. Among them, the price represents the number of HPV types that can be prevented, while the protection rate represents how the protection effect of this type is.

Protection of vaccine = (the incidence of control group-the incidence of vaccination group)/The incidence of the control group*100%, that is, the percentage of the decreased infection rate of vaccination in clinical trials compared to the decreased infection rate of the placebo. For example, assuming that at the end of the clinical trial, the incidence of vaccination group was 1%and the incidence of the vaccine group was 10%. The protection rate of the vaccine was 90%. Considering the importance of protection rates, the minimum standard for protection rates when the World Health Organization (WHO) and the US FDA were approved for listing were 50%.

Wan Taixin was approved for listing in December 2019.在保护率方面，根据临床试验分析报告，在预防HPV16/18型相关癌前病变这项指标上，葛兰素史克二价疫苗保护率(95%置信区间)达到87.3%(5.3-99.7)， The Merida East Four Valentine's vaccine reaches 100%(32.3-100), and Xin Kening reaches 100%(55.6-100); in the effectiveness of preventing HPV16/18 continuous infection in 6 months, the protection rate of Xin Kening vaccine reaches 97.8% (95%of the confidence range 87.1-99.9), the protection rate of the two-valent vaccine of the GlaxoSmot is 96.3%, and the protection rate of the Merida East four-price vaccine was 75.9%.

In addition, no serious adverse incidents related to vaccination were occurred during the research period.

The results show that the incidence of severe adverse incidents in the test group and control groups is similar (267 of 3691 participants in the vaccine group [7.2%]) and 290 of the 3681 participants in the control group, and all serious bad bad The incident has nothing to do with vaccination.

Bad event statistical form

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