Barnabas Ruanne V, Brown Elizabeth R, Onono Maricianah A, Bukusi Elizabeth A, Njoroge Betty, Winer Rachel L, Galloway Denise A, Pinder Leeya F, Donnell Deborah, N Wakhungu Imelda, Biwott Charlene, Kimanthi Syovata, Heller Kate B, Kanjilal Diane G, Pacella Daniel, Morrison Susan, A Rechkina Elena, L Cherne Stephen, Schaafsma Torin T, McClelland R Scott, Celum Connie, Baeten Jared M, Mugo Nelly R
Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
School of Medicine, Harvard Medical School, Boston, MA, USA.
Nat Med. 2023 Dec;29(12):3224-3232. doi: 10.1038/s41591-023-02658-0. Epub 2023 Dec 4.
Cervical cancer burden is high where prophylactic vaccination and screening coverage are low. We demonstrated in a multicenter randomized, double-blind, controlled trial that single-dose human papillomavirus (HPV) vaccination had high vaccine efficacy (VE) against persistent infection at 18 months in Kenyan women. Here, we report findings of this trial through 3 years of follow-up. Overall, 2,275 healthy women aged 15-20 years were recruited and randomly assigned to receive bivalent (n = 760), nonavalent (n = 758) or control (n = 757) vaccine. The primary outcome was incident-persistent vaccine type-specific cervical HPV infection. The primary evaluation was superiority analysis in the modified intention-to-treat (mITT) HPV 16/18 and HPV 16/18/31/33/45/52/58 cohorts. The trial met its prespecified end points of vaccine type-specific persistent HPV infection. A total of 75 incident-persistent infections were detected in the HPV 16/18 mITT cohort: 2 in the bivalent group, 1 in the nonavalent group and 72 in the control group. Nonavalent VE was 98.8% (95% CI 91.3-99.8%, P < 0.0001) and bivalent VE was 97.5% (95% CI 90.0-99.4%, P < 0.0001). Overall, 89 persistent infections were detected in the HPV 16/18/31/33/45/52/58 mITT cohort: 5 in the nonavalent group and 84 in the control group; nonavalent VE was 95.5% (95% CI 89.0-98.2%, P < 0.0001). There were no vaccine-related severe adverse events. Three years after vaccination, single-dose HPV vaccination was highly efficacious, safe and conferred durable protection. ClinicalTrials.gov no. NCT03675256 .
在预防性疫苗接种和筛查覆盖率较低的地区，宫颈癌负担较重。我们在一项多中心随机、双盲、对照试验中证明，单剂量人乳头瘤病毒（HPV）疫苗接种对肯尼亚女性18个月时的持续性感染具有较高的疫苗效力（VE）。在此，我们报告该试验3年随访的结果。总体而言，招募了2275名15 - 20岁的健康女性，并随机分配接受二价（n = 760）、九价（n = 758）或对照（n = 757）疫苗。主要结局是新发持续性疫苗型特异性宫颈HPV感染。主要评估是在改良意向性分析（mITT）HPV 16/18和HPV 16/18/31/33/45/52/58队列中的优效性分析。该试验达到了其预设的疫苗型特异性持续性HPV感染终点。在HPV 16/18 mITT队列中总共检测到75例新发持续性感染：二价组2例，九价组1例，对照组72例。九价疫苗效力为98.8%（95%CI 91.3 - 99.8%，P < 0.0001），二价疫苗效力为97.5%（95%CI 90.0 - 99.4%，P < 0.0001）。总体而言，在HPV 16/18/31/33/45/52/58 mITT队列中检测到89例持续性感染：九价组5例，对照组84例；九价疫苗效力为95.5%（95%CI 89.0 - 98.2%，P < 0.0001）。没有与疫苗相关的严重不良事件。接种疫苗三年后，单剂量HPV疫苗接种具有高效力、安全性且能提供持久保护。ClinicalTrials.gov编号：NCT03675256 。
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