To establish therapeutic dendritic cell (DC) vaccines targeting HPV 16/18 E6/E7 protein to block the progression of CIN1/CIN2 to cervical cancer and evaluate the safety and efficacy of the vaccines.

Start Date01 Apr 2019

Sponsor / Collaborator

Shenzhen People's Hospital

100 Clinical Results associated with DC vaccines targeting HPV 16/18 E6/ E7 protein(Shenzhen People's Hospital)

100 Translational Medicine associated with DC vaccines targeting HPV 16/18 E6/ E7 protein(Shenzhen People's Hospital)

100 Patents (Medical) associated with DC vaccines targeting HPV 16/18 E6/ E7 protein(Shenzhen People's Hospital)

Literatures (Medical) associated with DC vaccines targeting HPV 16/18 E6/ E7 protein(Shenzhen People's Hospital)

01 Nov 2022·Vaccine

Immunogenicity and safety of two novel human papillomavirus 4- and 9-valent vaccines in Chinese women aged 20–45 years: A randomized, blinded, controlled with Gardasil (type 6/11/16/18), phase III non-inferiority clinical trial

Article

Author: Huang, Zhuhang ; Li, Zehong ; Ou, Zhiqiang ; Huang, Meilian ; Yu, Yebin ; Hu, Meng ; Ji, Ying ; Shu, Yajun ; Li, Chunyun ; Zhang, Jikai ; Zhang, Gaoxia ; Qin, Haiyang ; Shen, Qiong ; Li, Yuan ; Zhang, Li

BACKGROUNDHuman papillomavirus (HPV) infections were the main cause of anogenital cancers and warts. HPV 6/11/16/18 vaccines provide protection against the high-risk types of HPV responsible for 70% of cervical cancers and 90% of genital warts. This randomized, blinded, non-inferiority phase III trial was to determine whether immunogenicity and tolerability would be non-inferior among women after receiving two novel 4- and 9-valent HPV vaccines (4vHPV, HPV 6/11/16/18; 9vHPV, HPV 6/11/16/18/31/33/45/52/58) compared with those receiving Gardasil 4 (4-valent).METHODS1680 females between 20 and 45 years were randomized in a 2:1:1 ratio to 20-26, 27-35, or 36-45 y groups. Subjects then equally assigned to receive 4vHPV, 9vHPV or Gardasil 4 (control) vaccine at months 0, 2, and 6. End points included non-inferiority of HPV-6/11/16/18 antibodies for 4vHPV versus control, and 9vHPV versus control and safety. The immunogenicity non-inferiority was pre-defined as the lower bound of 95% confidence interval (CI) of seroconversion rate (SCR) difference > -10% and the lower bound of 95% CI of geometric mean antibody titer (GMT) ratio > 0.5.RESULTSAmong the three vaccine groups, more than 99% of the participants seroconverted to all 4 HPV types. The pre-specified statistical non-inferiority criterion for the immunogenicity hypothesis was met: all the lower bounds of 95% CIs on SCR differences exceeded -10% for each vaccine HPV type and the corresponding lower bounds of 95% CIs for GMT ratios > 0.5. Across vaccination groups, the most common vaccination reaction were injection-site adverse events (AEs), including pain, swelling, and redness. General and serious AEs were similar in the three groups. There were no deaths.CONCLUSIONSThis study demonstrated that the novel 4- and 9-valent HPV vaccination was highly immunogenic and generally well tolerated, both of which were non-inferior to Gardasil 4 in immunogenicity and safety.

01 Dec 2021·BMJ OpenQ4 · MEDICINE

Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial

Q4 · MEDICINE

ArticleOA

Author: Eriksson, Tiina ; Nieminen, Pekka ; Harjula, Katja ; Luostarinen, Tapio ; Kuortti, Marjo ; Soderlund-Strand, Anna ; Palmroth, Johanna ; Hokkanen, Mari ; Pukkala, Eero ; Karttunen, Heidi ; Lehtinen, Matti ; Dillner, Joakim ; Bly, Anne ; Nummela, Mervi ; Petäjä, Tiina ; Paavonen, J ; Lagheden, Camilla ; Veivo, Ulla ; Apter, Dan ; Gray, Penelope ; Heikkilä, Kaisa

BackgroundHuman papillomavirus (HPV) vaccination protects against HPV, a necessary risk factor for cervical cancer. We now report results from population-based follow-up of randomised cohorts that vaccination provides HPV-type-specific protection against invasive cancer.MethodsIndividually and/or cluster randomised cohorts of HPV-vaccinated and non-vaccinated women were enrolled in 2002–2005. HPV vaccine cohorts comprised originally 16–17 year-old HPV 16/18-vaccinated PATRICIA (NCT00122681) and 012 trial (NCT00169494) participants (2465) and HPV6/11/16/18-vaccinated FUTURE II (NCT00092534) participants (866). Altogether, 3341 vaccines were followed by the Finnish Cancer Registry in the same way as 16 526 non-HPV-vaccinated controls. The control cohort stemmed from 15 665 originally 18–19 years-old women enrolled in 2003 (6499) or 2005 (9166) and 861 placebo recipients of the FUTURE II trial. The follow-up started 6 months after the clinical trials in 2007 and 2009 and ended in 2019. It was age aligned for the cohorts.FindingsDuring a follow-up time of up to 11 years, we identified 17 HPV-positive invasive cancer cases (14 cervical cancers, 1 vaginal cancer, 1 vulvar cancer and 1 tongue cancer) in the non-HPV-vaccinated cohorts and no cases in the HPV-vaccinated cohorts. HPV typing of diagnostic tumour blocks found HPV16 in nine cervical cancer cases, HPV18, HPV33 and HPV52 each in two cases and HPV45 in one cervical cancer case. The vaginal, vulvar and tongue cancer cases were, respectively, positive for HPV16, HPV52/66 and HPV213. Intention-to-treat vaccine efficacy against all HPV-positive cancers was 100% (95% CI 2 to 100, p<0.05).InterpretationVaccination is effective against invasive HPV-positive cancer.Trial registration numberNCT00122681, Post-results; NCT00169494, Post-results; NCT00092534, Post-results.

01 Feb 2020·JNCI: Journal of the National Cancer InstituteQ1 · MEDICINE

Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Bivalent Human Papillomavirus Vaccine: An Interim Analysis of a Randomized Clinical Trial

Q1 · MEDICINE

Article

Author: Pan, Qin-Jing ; Zhao, Bin ; Li, Chang-Gui ; Wei, Li-Hui ; Zhu, Feng-Cai ; Lin, Zhi-Jie ; Zhao, Chao ; Zhang, Xun ; Liu, Wen-Yu ; Li, Yan-Ping ; Zhao, Jun ; Cui, Xue-Lian ; Li, Cai-Hong ; Huang, Shou-Jie ; Ke, Li-Dong ; Dai, Cui-Hong ; Chu, Kai ; Guo, Dong-Ping ; Li, Qing ; Li, Mei ; Qiao, You-Lin ; Zhao, Fang-Hui ; Gao, Guo-Qi ; Li, Yi-Min ; Zhang, Jun ; Wu, Xin ; Li, Ba-Yi ; Li, Shao-Wei ; Li, Rong-Cheng ; Wang, Jun-Zhi ; Li, Juan ; Zhao, Hui ; Pan, Hui-Rong ; Su, Ying-Ying ; Zheng, Feng-Xian ; Wu, Ting ; Hong, Ying ; Li, Ming-Qiang ; Guo, Meng ; Chen, Wen ; Hu, Yue-Mei ; Zhang, Wen-Hua ; Tang, Jie ; Xia, Ning-Shao ; Jiang, Yun-Fei

AbstractBackgroundThe high cost and insufficient supply of human papillomavirus (HPV) vaccines have slowed the pace of controlling cervical cancer. A phase III clinical trial was conducted to evaluate the efficacy, safety, and immunogenicity of a novel Escherichia coli-produced bivalent HPV-16/18 vaccine.MethodsA multicenter, randomized, double-blind trial started on November 22, 2012 in China. In total, 7372 eligible women aged 18–45 years were age-stratified and randomly assigned to receive three doses of the test or control (hepatitis E) vaccine at months 0, 1, and 6. Co-primary endpoints included high-grade genital lesions and persistent infection (over 6 months) associated with HPV-16/18. The primary analysis was performed on a per-protocol susceptible population of individuals who were negative for relevant HPV type-specific neutralizing antibodies (at day 0) and DNA (at day 0 through month 7) and who received three doses of the vaccine. This report presents data from a prespecified interim analysis used for regulatory submission.ResultsIn the per-protocol cohort, the efficacies against high-grade genital lesions and persistent infection were 100.0% (95% confidence interval = 55.6% to 100.0%, 0 of 3306 in the vaccine group vs 10 of 3296 in the control group) and 97.8% (95% confidence interval = 87.1% to 99.9%, 1 of 3240 vs 45 of 3246), respectively. The side effects were mild. No vaccine-related serious adverse events were noted. Robust antibody responses for both types were induced and persisted for at least 42 months.ConclusionsThe E coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18–associated high-grade genital lesions and persistent infection in women.

100 Deals associated with DC vaccines targeting HPV 16/18 E6/ E7 protein(Shenzhen People's Hospital)

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Indication	Highest Phase	Country/Location	Organization	Date
Uterine Cervical Cancer	Phase 1	CN	Shenzhen People's Hospital	01 Apr 2019

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