Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomised, double-blind trial

Huh, Warner K.; Joura, Elmar A.; Giuliano, Anna R.; Iversen, Ole Erik; Andrade, Rosíres Pereira de; Ault, Kevin A.; Bartholomew, Deborah; Cestero, Ramon F.; Fedrizzi, Edison Natal; Hirschberg, Angelica Lindén; Mayrand, Marie Hélène; Ruiz-Sternberg, Ángela María; Stapleton, Jack T.; Wiley, Dorothy J.; Ferenczy, Alex; Kurman, Robert J.; Ronnett, Brigitte M.; Stoler, Mark H.; Cuzick, Jack; Garland, Suzanne M.; Kjær, Susanne K.; Bautista, Oliver; Haupt, Richard M.; Moeller, Erin; Ritter, Michael; Roberts, Christine C.; Shields, Christine; Luxembourg, Alain

doi:10.1016/s0140-6736(17)31821-4

Cited by 356 publications

(286 citation statements)

References 29 publications

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“…In the overall population, the vaccines were still effective, but in lower levels. More recently, Huh et al [45] published the efficacy results of the 9-valent vaccine compared to the 4-valent vaccine against precursor lesions of the uterine cervix. The study included approximately 14,000 women aged 16–26 years in 18 countries with no history of cervical cytology abnormalities and up to 4 sexual partners.…”

Section: Data From Clinical Trialsmentioning

confidence: 99%

HPV Vaccine: Updates and Highlights

2019

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HPV is the most common sexually transmitted biological agent and is the cause of many conditions in men and women, including precancer lesions and cancer. Three prophylactic HPV vaccines targeting high-risk HPV types are available in many countries worldwide: 2-, 4- and 9-valent vaccines. All the 3 vaccines use recombinant DNA technology and are prepared from the purified L1 protein that self-assembles to form HPV type-specific empty shells. This non-systematic review aims to summarize the HPV epidemiology and the vaccine development to review the landmark trials of HPV vaccine, to present to most remarkable results from clinical trials and the real world, and to stress the challenges and the barriers for HPV vaccine implementation.

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Section: Data From Clinical Trialsmentioning

confidence: 99%

HPV Vaccine: Updates and Highlights

2019

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“…Two Phase II studies of ADXS11‐011 in women with persistent, recurrent and/or refractory cervical cancer have been undertaken, with an ORR of between 2 and 11% and a 12‐month survival rate of 34–38% . Whether early introduction of ADXS11‐011 can delay or prevent recurrences is currently under evaluation in the Phase III trial, AIM2CERVE (clinicaltrials.gov NCT02853604).…”

Section: Hpv Therapeutic Vaccinesmentioning

confidence: 99%

Targeted therapies in gynaecological cancers

Crusz

Miller

2019

Histopathology

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The treatment of cancer has changed dramatically over the last decade, driven by increased understanding of the cancer genome, immune landscape, molecular alterations and aberrant pathways that drive cancer progression. Advances in molecular biology have led to the development of targeted agents, including monoclonal antibodies, small molecules and check‐point inhibitors. Unlike chemotherapy, which inhibits DNA replication and mitosis, these agents target cancer signalling pathways, stroma, immune microenvironment and vasculature in tumour tissues. In gynaecological cancer, drugs targeting defective DNA repair, such as PARP inhibitors, have been approved for advanced ovarian cancer, and drugs targeting angiogenesis have been used in the treatment of advanced or recurrent ovarian and cervical cancers. Immune check‐point inhibitors such as anti‐PD‐1/PD‐L1 antibodies have proved successful for mismatch repair‐deficient endometrial cancers and HPV‐targeted therapies are under development for HPV‐related malignancies. In this era of precision medicine, improved understanding of cancer biology and genomics needs to be utilised to develop predictive biomarkers for these targeted therapies to maximise patient benefit.

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“…This randomised controlled double-blind, efficacy and safety study1 of the 9vHPV vaccine was carried out in 18 countries. Inclusion criteria were: healthy women aged 16–26, no history of abnormal cervical cytology or biopsy and maximum of four lifetime sexual partners.…”

Section: Nine-valent Human Papillomavirus (Hpv) Vaccination Could Potmentioning

confidence: 99%