【medical-news】HPV疫苗可以预防大多数的子宫颈癌、癌前病变
发布于 2007-06-30 · 浏览 1622 · IP 黑龙江黑龙江
这个帖子发布于 17 年零 316 天前，其中的信息可能已发生改变或有所发展。
HPV Vaccine May Prevent Most Cervical Cancer, Precancerous Lesions
http://www.medscape.com/viewarticle/559086
June 28, 2007 — The adjuvanted human papillomavirus (HPV) 16/18 vaccine showed 90% prophylactic efficacy against cervical intraepithelial neoplasia (CIN) associated with HPV16 or HPV18 and could be used for cervical cancer prevention, according to the results of a study published online today in The Lancet.
"The aim of this interim analysis of a large, international phase III study was to assess the efficacy of an AS04 adjuvanted L1 virus-like-particle prophylactic candidate vaccine against infection with human papillomavirus (HPV) types 16 and 18 in young women," write Jorma Paavonen, from the University of Helsinki, Finland, and colleagues from the HPV PATRICIA study group.
The investigators randomized 18,644 women, aged 15 to 25 years, to receive either HPV16/18 vaccine (n = 9319) or hepatitis A vaccine (n = 9325) at 0, 1, and 6 months. The HPV16/18 vaccine was an investigational formula based on the Havrix vaccine (GlaxoSmithKline Biologicals). Of the 18,644 women, 88 were excluded for high-grade cytology and 31 for missing cytology results, leaving 9258 women in the HPV16/18 vaccine group and 9267 in the control group.
The total vaccinated cohort included women with prevalent oncogenic HPV infections, often with several HPV types, as well as low-grade cytological abnormalities at study entry. Cervical cytology and biopsy were analyzed for 14 oncogenic HPV types using polymerase chain reaction.
The main outcome measure was vaccine efficacy against CIN2+ associated with HPV16 or HPV18, evaluated in women who were seronegative and DNA negative for the corresponding vaccine type at baseline (month 0), and allowing inclusion of lesions with several oncogenic HPV types. This interim event-defined analysis was triggered by detection of at least 23 cases in the total vaccinated cohort for efficacy of CIN2+ with HPV16 or HPV18 DNA in the lesion. Analyses were based on modified intention to treat.
At the time of the interim analysis, mean duration of follow-up for women in the primary analysis for efficacy was 14.8 ± 4.9 months. Two cases of CIN2+ were associated with HPV16 or HPV18 DNA in the HPV16/18 vaccine group compared with 21 cases in the control group. Of these 23 cases, 14 (2 in the HPV16/18 vaccine group and 12 in the control group) had several oncogenic HPV types.
Vaccine efficacy was 90.4% (97.9% confidence interval, 53.4 – 99.3; P < .0001) against CIN2+ containing HPV16/18 DNA. The level of protection against persistent infections with HPV16/18 was 80.4% at 6 months and 75.9% at 12 months. Safety outcomes were similar in both groups.
"The adjuvanted HPV16/18 vaccine showed prophylactic efficacy against CIN2+ associated with HPV16 or HPV18 and thus could be used for cervical cancer prevention," the authors write. "Our results show that the vaccine is effective, well-tolerated and immunogenic in a broad population of young adult women, lending support to its potential value in preventing CIN and cervical cancer."
Some of the authors report various financial conflicts of interest with Merck & Co, GlaxoSmithKline, and/or Sanofi Pasteur MSD.
In an accompanying comment, Jessica A. Kahn, from the University of Cincinnati College of Medicine in Ohio, and Robert D. Burk, from the Albert Einstein College of Medicine in New York City, call these interim efficacy data "encouraging" but note several limitations, such as brief follow-up (given that cervical carcinogenesis often develops over several decades) and increased adverse reactions among women in the HPV vaccine group.
"Poverty is strongly associated with high-risk HPV infection and cervical cancer," Drs. Kahn and Burk write. "If those who live in poverty cannot access a highly effective intervention such as HPV vaccines, disparities could worsen dramatically."
Lancet. Published online June 28, 2007.
http://www.medscape.com/viewarticle/559086
June 28, 2007 — The adjuvanted human papillomavirus (HPV) 16/18 vaccine showed 90% prophylactic efficacy against cervical intraepithelial neoplasia (CIN) associated with HPV16 or HPV18 and could be used for cervical cancer prevention, according to the results of a study published online today in The Lancet.
"The aim of this interim analysis of a large, international phase III study was to assess the efficacy of an AS04 adjuvanted L1 virus-like-particle prophylactic candidate vaccine against infection with human papillomavirus (HPV) types 16 and 18 in young women," write Jorma Paavonen, from the University of Helsinki, Finland, and colleagues from the HPV PATRICIA study group.
The investigators randomized 18,644 women, aged 15 to 25 years, to receive either HPV16/18 vaccine (n = 9319) or hepatitis A vaccine (n = 9325) at 0, 1, and 6 months. The HPV16/18 vaccine was an investigational formula based on the Havrix vaccine (GlaxoSmithKline Biologicals). Of the 18,644 women, 88 were excluded for high-grade cytology and 31 for missing cytology results, leaving 9258 women in the HPV16/18 vaccine group and 9267 in the control group.
The total vaccinated cohort included women with prevalent oncogenic HPV infections, often with several HPV types, as well as low-grade cytological abnormalities at study entry. Cervical cytology and biopsy were analyzed for 14 oncogenic HPV types using polymerase chain reaction.
The main outcome measure was vaccine efficacy against CIN2+ associated with HPV16 or HPV18, evaluated in women who were seronegative and DNA negative for the corresponding vaccine type at baseline (month 0), and allowing inclusion of lesions with several oncogenic HPV types. This interim event-defined analysis was triggered by detection of at least 23 cases in the total vaccinated cohort for efficacy of CIN2+ with HPV16 or HPV18 DNA in the lesion. Analyses were based on modified intention to treat.
At the time of the interim analysis, mean duration of follow-up for women in the primary analysis for efficacy was 14.8 ± 4.9 months. Two cases of CIN2+ were associated with HPV16 or HPV18 DNA in the HPV16/18 vaccine group compared with 21 cases in the control group. Of these 23 cases, 14 (2 in the HPV16/18 vaccine group and 12 in the control group) had several oncogenic HPV types.
Vaccine efficacy was 90.4% (97.9% confidence interval, 53.4 – 99.3; P < .0001) against CIN2+ containing HPV16/18 DNA. The level of protection against persistent infections with HPV16/18 was 80.4% at 6 months and 75.9% at 12 months. Safety outcomes were similar in both groups.
"The adjuvanted HPV16/18 vaccine showed prophylactic efficacy against CIN2+ associated with HPV16 or HPV18 and thus could be used for cervical cancer prevention," the authors write. "Our results show that the vaccine is effective, well-tolerated and immunogenic in a broad population of young adult women, lending support to its potential value in preventing CIN and cervical cancer."
Some of the authors report various financial conflicts of interest with Merck & Co, GlaxoSmithKline, and/or Sanofi Pasteur MSD.
In an accompanying comment, Jessica A. Kahn, from the University of Cincinnati College of Medicine in Ohio, and Robert D. Burk, from the Albert Einstein College of Medicine in New York City, call these interim efficacy data "encouraging" but note several limitations, such as brief follow-up (given that cervical carcinogenesis often develops over several decades) and increased adverse reactions among women in the HPV vaccine group.
"Poverty is strongly associated with high-risk HPV infection and cervical cancer," Drs. Kahn and Burk write. "If those who live in poverty cannot access a highly effective intervention such as HPV vaccines, disparities could worsen dramatically."
Lancet. Published online June 28, 2007.
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