A Phase 1 Trial Assessing the Safety and Tolerability of a Therapeutic DNA Vaccination Against HPV16 and HPV18 E6/E7 Oncogenes After Chemoradiation for Cervical Cancer

Hasan, Yasmin; Furtado, Larissa V.; Tergas, Ana I.; Lee, Nita; Brooks, Rebecca; McCall, Anne R.; Golden, Daniel W.; Jolly, Shruti; Fleming, Gini F.; Morrow, Matthew P.; Kraynyak, Kimberly A.; Sylvester, Albert J.; Arif, Fauzia; Levin, Matt; Schwartz, David; Boyer, Jean; Skolnik, Jeffrey; Esser, Mark T.; Kumar, Rakesh; Bagarazzi, Mark L.; Weichselbaum, Ralph R.; Spiotto, Michael T.

doi:10.1016/j.ijrobp.2020.02.031

Cited by 37 publications

(19 citation statements)

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“…INO-4800 developed by Inovio Pharmaceuticals (Pennsylvania, USA) involves intradermal plasmid delivery directly into cells using INOVIO's proprietary hand-held device called CELLECTRA® 2000 ( 201 , 202 ). The principle of CELLECTRA® 2000 is to use a brief electrical pulse to reversibly open small pores in the cell membrane to allow plasmid entry ( 203 ).…”

Section: Vaccine Platform Technologiesmentioning

confidence: 99%

The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies

et al. 2020

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There is an urgent need for effective countermeasures against the current emergence and accelerating expansion of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Induction of herd immunity by mass vaccination has been a very successful strategy for preventing the spread of many infectious diseases, hence protecting the most vulnerable population groups unable to develop immunity, for example individuals with immunodeficiencies or a weakened immune system due to underlying medical or debilitating conditions. Therefore, vaccination represents one of the most promising counter-pandemic measures to COVID-19. However, to date, no licensed vaccine exists, neither for SARS-CoV-2 nor for the closely related SARS-CoV or Middle East respiratory syndrome-CoV. In addition, a few vaccine candidates have only recently entered human clinical trials, which hampers the progress in tackling COVID-19 infection. Here, we discuss potential prophylactic interventions for SARS-CoV-2 with a focus on the challenges existing for vaccine development, and we review pre-clinical progress and ongoing human clinical trials of COVID-19 vaccine candidates. Although COVID-19 vaccine development is currently accelerated via so-called fast-track programs, vaccines may not be timely available to have an impact on the first wave of the ongoing COVID-19 pandemic. Nevertheless, COVID-19 vaccines will be essential in the future for reducing morbidity and mortality and inducing herd immunity, if SARS-CoV-2 becomes established in the population like for example influenza virus.

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Section: Vaccine Platform Technologiesmentioning

confidence: 99%

The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies

et al. 2020

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“…MEDI0457 is composed of DNA plasmids encoding the E6/E7 genes of HPV 16 and HPV 18 (VGX-3100) and DNA plasmid encoding the human interleukin-12 (IL-12), INO-9012, which triggers the immune system 6 . A recent paper revealed that MEDI0457 was well-tolerated by patients with cervical cancer after receiving chemoradiation and raised the idea of combining tumor-specific vaccines with radiotherapy 57 . MEDI0457 was also well tolerated by patients suffering from HPV-associated HNC cancer showing elevated antigen-specific T cell activity 58 .…”

Section: Ongoing Clinical Trials On Treatment For Hpv-related Cancersmentioning

confidence: 99%

Biological and clinical aspects of HPV-related cancers

2020

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“…A total of 25 trials were identified assessing therapeutic vaccines in cervical cancer patients [ 21 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 ], of which 4 were not specific to cervical cancer but included a larger population with various cancers. The trials were published between 1989 and 2020.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and Safety of Immunotherapy for Cervical Cancer—A Systematic Review of Clinical Trials

Schmidt

Battista

Schmidt

et al. 2022

Cancers

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Purpose: To systematically review the current body of evidence on the efficacy and safety of immunotherapy for cervical cancer (CC). Material and Methods: Medline, the Cochrane Central Register of Controlled Trials and Web of Science were searched for prospective trials assessing immunotherapy in CC patients in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Full-text articles in English and German reporting outcomes of survival, response rates or safety were eligible. Results: Of 4655 screened studies, 51 were included (immune checkpoint inhibitors (ICI) n=20; therapeutic vaccines n = 25; adoptive cell transfer therapy n=9). Of these, one qualified as a phase III randomized controlled trial and demonstrated increased overall survival following treatment with pembrolizumab, chemotherapy and bevacizumab. A minority of studies included a control group (n = 7) or more than 50 patients (n = 15). Overall, response rates were low to moderate. No response to ICIs was seen in PD-L1 negative patients. However, few remarkable results were achieved in heavily pretreated patients. There were no safety concerns in any of the included studies. Conclusion: Strong evidence on the efficacy of strategies to treat recurrent or metastatic cervical cancer is currently limited to pembrolizumab in combination with chemotherapy and bevacizumab, which substantiates an urgent need for large confirmatory trials on alternative immunotherapies. Overall, there is sound evidence on the safety of immunotherapy in CC.

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A Phase 1 Trial Assessing the Safety and Tolerability of a Therapeutic DNA Vaccination Against HPV16 and HPV18 E6/E7 Oncogenes After Chemoradiation for Cervical Cancer

Cited by 37 publications

References 50 publications

The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies

The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies

Biological and clinical aspects of HPV-related cancers

Efficacy and Safety of Immunotherapy for Cervical Cancer—A Systematic Review of Clinical Trials

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