Literature DB >> 15068256

Endpoints in vaccine trials.

Michael G Hudgens1, Peter B Gilbert, Steven G Self.   

Abstract

In this paper we discuss statistical considerations regarding endpoints in preventive vaccine trials. Brief discussion is given to preclinical, Phase I, and Phase II trials, with the bulk of attention paid to endpoint choice and analysis in Phase III efficacy trials. In addition to traditional efficacy measures of vaccine effects for immunized individuals, consideration is given to waning, strain specific efficacy, correlates of protective immunity, postinfection endpoints, and cluster randomized trials.

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Year:  2004        PMID: 15068256     DOI: 10.1191/0962280204sm356ra

Source DB:  PubMed          Journal:  Stat Methods Med Res        ISSN: 0962-2802            Impact factor:   3.021


  9 in total

1.  Evaluating the efficacy of a malaria vaccine.

Authors:  Dylan S Small; Jing Cheng; Thomas R Ten Have
Journal:  Int J Biostat       Date:  2010-02-22       Impact factor: 0.968

2.  RTS,S vaccination is associated with serologic evidence of decreased exposure to Plasmodium falciparum liver- and blood-stage parasites.

Authors:  Joe J Campo; John J Aponte; Jeff Skinner; Rie Nakajima; Douglas M Molina; Li Liang; Jahit Sacarlal; Pedro L Alonso; Peter D Crompton; Philip L Felgner; Carlota Dobaño
Journal:  Mol Cell Proteomics       Date:  2014-12-29       Impact factor: 5.911

Review 3.  Artificial Intelligence-Based Data-Driven Strategy to Accelerate Research, Development, and Clinical Trials of COVID Vaccine.

Authors:  Ashwani Sharma; Tarun Virmani; Vipluv Pathak; Anjali Sharma; Kamla Pathak; Girish Kumar; Devender Pathak
Journal:  Biomed Res Int       Date:  2022-07-06       Impact factor: 3.246

4.  Quantifying Efficiency Gains of Innovative Designs of Two-Arm Vaccine Trials for COVID-19 Using an Epidemic Simulation Model.

Authors:  Rob Johnson; Chris Jackson; Anne Presanis; Sofia S Villar; Daniela De Angelis
Journal:  Stat Biopharm Res       Date:  2021-07-30       Impact factor: 1.452

5.  Needle size for vaccination procedures in children and adolescents.

Authors:  Paul V Beirne; Sarah Hennessy; Sharon L Cadogan; Frances Shiely; Tony Fitzgerald; Fiona MacLeod
Journal:  Cochrane Database Syst Rev       Date:  2018-08-09

6.  An agent-based model of dengue virus transmission shows how uncertainty about breakthrough infections influences vaccination impact projections.

Authors:  T Alex Perkins; Robert C Reiner; Guido España; Quirine A Ten Bosch; Amit Verma; Kelly A Liebman; Valerie A Paz-Soldan; John P Elder; Amy C Morrison; Steven T Stoddard; Uriel Kitron; Gonzalo M Vazquez-Prokopec; Thomas W Scott; David L Smith
Journal:  PLoS Comput Biol       Date:  2019-03-20       Impact factor: 4.475

Review 7.  Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine.

Authors:  Natalie Thiel; Casey Selwyn; Georgina Murphy; Shmona Simpson; Ajoy C Chakrabarti
Journal:  NPJ Vaccines       Date:  2021-04-22       Impact factor: 7.344

Review 8.  The clinical development process for a novel preventive vaccine: An overview.

Authors:  K Singh; S Mehta
Journal:  J Postgrad Med       Date:  2016 Jan-Mar       Impact factor: 1.476

Review 9.  The SARS-CoV-2 mutations versus vaccine effectiveness: New opportunities to new challenges.

Authors:  Jonaid Ahmad Malik; Sakeel Ahmed; Aroosa Mir; Mrunal Shinde; Onur Bender; Farhan Alshammari; Mukhtar Ansari; Sirajudheen Anwar
Journal:  J Infect Public Health       Date:  2022-01-05       Impact factor: 3.718

  9 in total

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