GlaxoSmithKline (GSK) announced on October 21 that the ZOSTER-049 extended study has achieved positive interim results: the initial recombinant shingles vaccine Xinanli can provide at least 10 years of shingles protection after treatment. Interim analysis data will be released at the IDWeek conference in Washington, USA on October 22, 2022.
The results of the previous two phase III clinical trials showed that during the follow-up period about 4 years after vaccination, Xin'anlishi's protective effect on shingles in adults aged 50 and above reached 97%, and herpes protective effect on adults aged 70 and above reached 91%.
ZOSTER-049 is an open, long-term follow-up (LTFU) study based on the above two key phase III clinical trials. The purpose of this study was to evaluate the protective efficacy, safety and immunogenicity of the vaccine within 6 years after the two clinical trials mentioned above. The interim analysis results of the fourth year showed that the protective efficacy of the vaccine was 81.6% from 5.6 to 9.6 years after vaccination. The protective efficacy of the vaccine is 89.0% from 1 month after the second dose to 10 years after the vaccination. At present, the study is still in progress and will continue to evaluate the long-term efficacy, immunogenicity and safety of the vaccine.
shingles are caused by reactivation of varicella-zoster virus (VZV). As we age, the immune system loses the ability to produce a strong and effective immune response, thereby increasing the risk of shingles. This disease can cause unbearable pain, and some patients still experience severe pain after the rash fades. This nerve pain is called postherpetic neuralgia and can last for months or even years.
recombinant shingles vaccine (RZV) Xinanlishi is the first approved shingles vaccine that combines inactive antigens with GlaxoSmithKline patented adjuvant system. It can help overcome the decline in immune function as you age and help protect the elderly from the harms of this disease.
, Chief Investigator of the Valencia Community Health and Biomedical Research Foundation (FISABIO), said: "Shinestone is a painful disease, and one-third of people suffer from shingles in their lifetime. Now, for the first time, we can confirm that for the first time that the recombinant shingles vaccine can provide at least 10 years of overall clinical benefit, giving people and medical staff confidence in the durability of vaccination to prevent shingles."
[Reporter] Yan Huifang
[Author] Yan Huifang
Healthy Living Circle
