Concerned about cervical cancer Is it safe for Chinese women aged 26 years and older to receive the AS04-HPV-16/18 vaccine? Is the vaccine long-term effective after 18-25 years old?

Don't have time to read the full analysis?

Let's look at the answer first:

This study further demonstrates the safety and efficacy

• Throughout the study period, women over the age of 26 did not have any safety issues

  
  

• This study demonstrates that the protective effects of the vaccine last for more than 10 years

  
  

Safety of AS04-HPV-16/18 vaccine in Chinese women aged 26 years and older and long-term protective effect in women vaccinated at age 18–25 years: A 10-year follow-up study

Chinese: A 10-year follow-up study on the safety of AS04-HPV-16/18 vaccination in Chinese women aged 26 years and older and the long-lasting protective effects of vaccination in women aged 18 to 25 years

Cervical cancer is an important disease that threatens women's health worldwide, and in 2018, it is estimated that the number of new confirmed cases of

Persistent infection with human papillomavirus (HPV) can lead to cervical cancer

So far, four HPV vaccines have been licensed in China: AS04 adjuvants HPV-16/18 vaccine (AS04-HPV-16/18, GlaxoSmithKline), HPV-6/11/16/16/18 vaccine (4vHPV, Merck) and HPV-6/11/18/31/33/45/52/58 vaccine (9vHPV, Merck), and China has also developed the HPV-16/18 vaccine (Wantai Canghai).

After the first HPV vaccines (AS04-HPV-16/18 and 4vHPV) were developed and brought to market, vaccination programs

Multiple clinical trials as well as observational studies have confirmed the protective effects

This study is an extended study that began 4 years after the end of the Critical Efficacy Study (HPV-039), which had committed to the ethics committee to vaccinate all participants who used placebo in the key study with the AS04-HPV16/18 vaccine
.

The primary objective of this study was to assess the safety
of AS04-HPV16/18 vaccination in the key trials in women aged 26 years and older who had been included in the placebo group.

In addition, the study evaluated the long-term effects of AS04-HPV16/18 vaccine on infection nearly 10 years after vaccination in key studies, as well as efficacy against virological, cytology, and histopathological endpoints
.

This study further demonstrates the safety and efficacy
of AS04-HPV-16/18 vaccination in Chinese women.

Throughout the study period, women over the age of 26 did not have any safety issues
after receiving the AS04-HPV-16/18 vaccine.

This observation is consistent
with clinical trial safety characteristics and post-marketing experience of ASs-containing vaccines.

This study demonstrates that the protective effects of the vaccine last for more than 10 years
.

Within 10 years of initial vaccination, the AS04-HPV-16/18 vaccine remained effective against HPV-16 and HPV-18 virus infections, with a response rate of 82.
8%, 79.
8%, and 80.
8%,
respectively.

At the clinical endpoint, the vaccine was 94.
8% and 90.
5%
effective against HPV-16/18virus-associated CIN1+ and CIN2+ lesions, respectively.

This also confirms the observational findings, concluding that the initial study supports the efficacy
of the AS04-HPV-16/18 vaccine in Chinese women aged 18 to 25 years.

After the last follow-up in the initial study phase, 3537 women were selected to measure clinical endpoint results
over a period of approximately 4 years (48.
8 months).

The 10-year observational study conducted at the end of the initial study yielded similar results for HPV-16/18 virus infection, ASC-US+, CIN1+, and CIN2+, with 78.
4% (95% confidence interval: 68.
5–85.
5), 91.
6% (95% confidence interval: 79.
4–97.
4), and 93.
3% (95% confidence interval: 56.
2– 95%, respectively), 99.
8) and 87.
3% (95% confidence interval: 5.
5–99.
7
).

Previous long-term efficacy results at year 9.
4 showed that the vaccine was associated with HPV-16/18 virus-associated ASC-US+ (97.
1%), despite excluding a small number of participants; 95% confidence interval: 82.
5–99.
9), CIN1+ (100%; 95% confidence intervals: 45.
2–100) and CIN2+ (100%; The 95% confidence interval: −128.
1–100) still has a high VE, and the results demonstrate that the vaccine can prevent CIN2+ and reach the alternative efficacy endpoint
.

The proportion of women infected with HPV carcinogenic viruses observed in the current study is consistent with current epidemiological findings, showing a higher
incidence of HPV-51, -52, and -58 virus infections.

Overall, current studies confirm the acceptable safety of the AS04-HPV-16/18 vaccine for Chinese women aged 26 years and older
.

In addition, the study confirmed the sustained efficacy of AS04-HPV-16/18 vaccines from efficacy trials in other countries around the world
.

Combined with the results of this study, it can be confirmed that the vaccine has a greater benefit and a lower risk, and confirms that it has a large preventive health intervention role
in HPV infection and related diseases.

Scan the code to get the original paper for free

Introduction to the journal

The Asia-Pacific Journal of Clinical Oncology (AJCO) is an interdisciplinary oncology journal that aims to provide a platform
that fosters collaboration and information exchange in cancer treatment and care in different countries in the Asia-Pacific region.

The journal publishes preclinical, translational, clinical trial, and epidemiological studies to showcase new findings
of clinical significance.

The editors-in-chief of AJCO are Professor Wang Mengzhao, Head of the Department of Respiratory and Critical Care Medicine at Peking Union Medical College Hospital, and Professor Stephen Ackland
, School of Health, University of Newcastle.

The editorial board is a strong line-up of well-known scholars and doctors from all over the world, especially in many countries in the Asia-Pacific region, including China, Australia, Japan, South Korea, Singapore and so on
.

Journal Home Page Links:

https://onlinelibrary.
wiley.
com/journal/17437563

Submission Website:

https://wiley.
atyponrex.
com/dashboard/?journalCode=ajco

Like, watch, share, come to a one-click triple!