In developing countries, risk of human papillomavirus (HPV) infection may be increased by the high prevalence of human immunodeficiency virus (HIV) infection. We evaluated the safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-infected women in South Africa. Asymptomatic HIV-positive women aged 18-25 years (N=120) were stratified by CD4⁺ T-cell count and randomised (1:1) to receive HPV-16/18 vaccine (Cervarix®; GlaxoSmithKline Vaccines) or placebo (Al[OH]3) at 0, 1 and 6 months (double-blind). HIV-negative women (N=30) received HPV-16/18 vaccine (open label). Anti-HPV-16/18 antibody and CD4⁺ T-cell responses, CD4⁺ T-cell count, HIV viral load, HIV clinical stage and safety were evaluated for 12 months. The safety and reactogenicity profile of the HPV-16/18 vaccine was comparable in HIV-positive and HIV-negative women. Irrespective of baseline HPV status, all HIV-positive and HIV-negative women who received the HPV-16/18 vaccine were seropositive for both HPV-16 and HPV-18 after the second vaccine dose (month 2) and remained seropositive for both antigens at month 12. Anti-HPV-16/18 antibody titres at month 12 remained substantially above levels associated with natural infection. The HPV-16/18 vaccine induced sustained anti-HPV-16/18 CD4⁺ T-cell responses in both HIV-positive and HIV-negative women. No impact of baseline CD4⁺ T-cell count or HIV viral load was observed on the magnitude of the immune response in HIV-positive women. In HIV-positive women, CD4⁺ T-cell count, HIV viral load and HIV clinical stage were unaffected by HPV-16/18 vaccine administration. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine appears immunogenic and well-tolerated in women with HIV infection. Study ID: 107863/NCT00586339.

译文

:在发展中国家,人乳头瘤病毒(HPV)感染的风险可能因人免疫缺陷病毒(HIV)感染的高流行而增加。我们评估了HPV-16 / 18 AS04佐剂在南非感染HIV的妇女中的安全性和免疫原性。将18-25岁(N = 120)的无症状HIV阳性女性按CD4⁺T细胞计数进行分层,并随机分配(1:1)接受HPV-16 / 18疫苗(Cervarix®; GlaxoSmithKline疫苗)或安慰剂(Al [OH] 3)在第0、1和6个月(双盲)。 HIV阴性妇女(N = 30)接受了HPV-16 / 18疫苗(开放标签)。评估12个月的抗HPV-16 / 18抗体和CD4βT细胞反应,CD4βT细胞计数,HIV病毒载量,HIV临床分期和安全性。 HPV-16 / 18疫苗的安全性和反应原性在HIV阳性和HIV阴性的妇女中相当。不论基线HPV状况如何,所有接受HPV-16 / 18疫苗的HIV阳性和HIV阴性妇女在第二剂疫苗(第2个月)后均对HPV-16和HPV-18呈血清阳性,而对两种抗原仍呈血清阳性在第12个月时,抗HPV-16 / 18抗体滴度在第12个月时仍显着高于与自然感染有关的水平。 HPV-16 / 18疫苗可在HIV阳性和HIV阴性的女性中诱导持续的抗HPV-16 / 18CD4βT细胞应答。没有观察到基线CD4⁺T细胞计数或HIV病毒载量对HIV阳性妇女的免疫反应程度有影响。在HIV阳性妇女中,HPV-16 / 18疫苗接种不会影响CD4⁺T细胞计数,HIV病毒载量和HIV临床分期。总之,HPV-16 / 18 AS04佐剂疫苗在具有HIV感染的女性中具有免疫原性和良好的耐受性。研究ID:107863 / NCT00586339。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录