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000291649 041__ $$aEnglish
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000291649 1001_ $$aDull, Peter M$$b0
000291649 245__ $$aMeeting report: Considerations for trial design and endpoints in licensing therapeutic HPV16/18 vaccines to prevent cervical cancer.
000291649 260__ $$aAmsterdam$$bElsevier$$c2024
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000291649 500__ $$a2024 Nov 14;42(25):126100 / Conference report / #LA:D410#
000291649 520__ $$aCervical cancer is a major cause of morbidity and mortality globally with a disproportionate impact on women in low- and middle-income countries. In 2021, the World Health Organization (WHO) called for increased vaccination, screening, and treatment to eliminate cervical cancer. However, even with widespread rollout of human papillomavirus (HPV) prophylactic vaccines, millions of women who previously acquired HPV infections will remain at risk for progression to cancer for decades to come. The development and licensing of an affordable, accessible therapeutic HPV vaccine, designed to clear or control carcinogenic HPV and/or to induce regression precancer could significantly contribute to the elimination efforts, particularly benefiting those who missed out on the prophylactic vaccine. One barrier to development of such vaccines is clarity around the regulatory pathway for licensure. In Washington, D.C. on September 12-13, 2023, a meeting was convened to provide input and guidance on trial design with associated ethical and regulatory considerations. This report summarizes the discussion and conclusions from the meeting. Expert presentation topics included the current state of research, potential regulatory challenges, WHO preferred product characteristics, modeling results of impact of vaccine implementation, epidemiology and natural history of HPV infection, immune responses related to viral clearance and/or precancer regression including potential biomarkers, and ethical considerations. Panel discussions were held to explore specific trial design recommendations to support the licensure process for two vaccine indications: (1) treatment of prevalent HPV infection or (2) treatment of cervical precancers. Discussion covered inclusion/exclusion criteria, study endpoints, sample size and power, safety, study length, and additional data needed, which are reported here. Further research of HPV natural history is needed to address identified gaps in regulatory guidance, especially for therapeutic vaccines intended to treat existing HPV infections.
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000291649 650_7 $$2Other$$aCervical cancer
000291649 650_7 $$2Other$$aHPV
000291649 650_7 $$2Other$$aHPV therapeutic vaccine
000291649 650_7 $$2Other$$aHuman papillomavirus
000291649 7001_ $$aAchilles, Sharon L$$b1
000291649 7001_ $$aAhmed, Rafi$$b2
000291649 7001_ $$aBarnabas, Ruanne V$$b3
000291649 7001_ $$aCampos, Nicole G$$b4
000291649 7001_ $$aChirgwin, Keith$$b5
000291649 7001_ $$aCohen, Jamie A$$b6
000291649 7001_ $$ade Sanjosé, Silvia$$b7
000291649 7001_ $$aDoorbar, John$$b8
000291649 7001_ $$aEinstein, Mark H$$b9
000291649 7001_ $$aEmerson, Claudia I$$b10
000291649 7001_ $$aGottlieb, Sami L$$b11
000291649 7001_ $$aHildesheim, Allan$$b12
000291649 7001_ $$aQiao, Youlin$$b13
000291649 7001_ $$aRuff, Paul$$b14
000291649 7001_ $$aSampson, Joshua N$$b15
000291649 7001_ $$aSasieni, Peter$$b16
000291649 7001_ $$aSchiffman, Mark$$b17
000291649 7001_ $$aShin, Haina$$b18
000291649 7001_ $$aStanley, Margaret A$$b19
000291649 7001_ $$aTrimble, Cornelia L$$b20
000291649 7001_ $$aWentzensen, Nicholas$$b21
000291649 7001_ $$0P:(DE-He78)3743a1b712edca2ffa829b7096d7037e$$aRiemer, Angelika$$b22$$eLast author$$udkfz
000291649 7001_ $$aSchiller, John T$$b23
000291649 7001_ $$aKreimer, Aimée R$$b24
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