Optimizing immunogenicity and product presentation of a SARS-CoV-2 subunit vaccine composition: effects of delivery route, heterologous regimens with self-amplifying RNA vaccines, and lyophilization.

Autor: Lykins WR; Access to Advanced Health Institute, Seattle, WA, United States., Pollet J; Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, Houston, TX, United States.; Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States., White JA; PATH, Seattle, WA, United States., Keegan B; Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, Houston, TX, United States.; Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States., Versteeg L; Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, Houston, TX, United States.; Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States., Strych U; Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, Houston, TX, United States.; Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States., Chen WH; Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, Houston, TX, United States.; Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States., Mohamath R; Access to Advanced Health Institute, Seattle, WA, United States., Ramer-Denisoff G; Access to Advanced Health Institute, Seattle, WA, United States., Reed S; Access to Advanced Health Institute, Seattle, WA, United States., Renshaw C; Access to Advanced Health Institute, Seattle, WA, United States., Beaver S; Access to Advanced Health Institute, Seattle, WA, United States., Gerhardt A; Access to Advanced Health Institute, Seattle, WA, United States., Voigt EA; Access to Advanced Health Institute, Seattle, WA, United States., Tomai MA; 3M Health Care, St. Paul, MN, United States., Sitrin R; PATH, Seattle, WA, United States., Choy RKM; PATH, Seattle, WA, United States., Cassels FJ; PATH, Seattle, WA, United States., Hotez PJ; Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, Houston, TX, United States.; Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States.; Department of Biology, Baylor University, Waco, TX, United States., Bottazzi ME; Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, Houston, TX, United States.; Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States., Fox CB; Access to Advanced Health Institute, Seattle, WA, United States.; Department of Global Health, University of Washington, Seattle, WA, United States.

Publikováno v: Frontiers in immunology [Front Immunol] 2024 Dec 16; Vol. 15, pp. 1480976. Date of Electronic Publication: 2024 Dec 16 (Print Publication: 2024).

Concordance of in vitro and in vivo measures of non-replicating rotavirus vaccine potency.

Autor: McAdams D; PATH, 2201 Westlake Ave, Seattle, WA 98122, United States., Estrada M; PATH, 2201 Westlake Ave, Seattle, WA 98122, United States. Electronic address: mestrada@path.org., Holland D; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, 2030 Becker Drive, Lawrence, KS 66047, United States. Electronic address: daholland3@ku.edu., Singh J; PATH, 2201 Westlake Ave, Seattle, WA 98122, United States., Sawant N; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, 2030 Becker Drive, Lawrence, KS 66047, United States., Hickey JM; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, 2030 Becker Drive, Lawrence, KS 66047, United States. Electronic address: hickey1@ku.edu., Kumar P; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, 2030 Becker Drive, Lawrence, KS 66047, United States. Electronic address: prashant.kumar@ku.edu., Plikaytis B; BioStat Consulting, LLC, 10429, Big Canoe, Jasper, GA 30143-5125, United States., Joshi SB; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, 2030 Becker Drive, Lawrence, KS 66047, United States. Electronic address: joshi@ku.edu., Volkin DB; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, 2030 Becker Drive, Lawrence, KS 66047, United States. Electronic address: volkin@ku.edu., Sitrin R; PATH, 2201 Westlake Ave, Seattle, WA 98122, United States. Electronic address: rsitrin@path.org., Cryz S; PATH, 2201 Westlake Ave, Seattle, WA 98122, United States. Electronic address: scryz@path.org., White JA; PATH, 2201 Westlake Ave, Seattle, WA 98122, United States. Electronic address: jawhite@path.org.

Publikováno v: Vaccine [Vaccine] 2022 Aug 12; Vol. 40 (34), pp. 5069-5078. Date of Electronic Publication: 2022 Jul 22.

Quantification of trivalent non-replicating rotavirus vaccine antigens in the presence of aluminum adjuvant.

Autor: McAdams D; Medical Devices and Health Technologies Global Program, Formulation Technologies, PATH, Seattle, WA, USA., Lakatos K; Medical Devices and Health Technologies Global Program, Formulation Technologies, PATH, Seattle, WA, USA., Estrada M; Medical Devices and Health Technologies Global Program, Formulation Technologies, PATH, Seattle, WA, USA., Chen D; Medical Devices and Health Technologies Global Program, Formulation Technologies, PATH, Seattle, WA, USA., Plikaytis B; Biostat Consulting LLC, Big Canoe, GA, USA., Sitrin R; The Center for Vaccine Innovation and Access, PATH, Washington, DC, USA., White JA; Medical Devices and Health Technologies Global Program, Formulation Technologies, PATH, Seattle, WA, USA. Electronic address: jawhite@path.org.

Publikováno v: Journal of immunological methods [J Immunol Methods] 2021 Jul; Vol. 494, pp. 113056. Date of Electronic Publication: 2021 Apr 13.

Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities.

Autor: Akkermans A; National Institute for Public Health and the Environment (RIVM), the Netherlands., Chapsal JM; European Partnership for Alternatives to Animal Testing (EPAA), France., Coccia EM; Istituto Superiore di Sanità, Italy., Depraetere H; CEO, European Vaccine Initiative (EVI), Germany., Dierick JF; GSK, Belgium., Duangkhae P; Government Pharmaceutical Organization, Thailand., Goel S; Serum Institute of India Pvt. Ltd., India., Halder M; European Commission, Joint Research Centre (JRC), Ispra, Italy., Hendriksen C; Intravacc, the Netherlands., Levis R; Food and Drug Administration (FDA / CBER), USA., Pinyosukhee K; Ministry of Public Health, Thailand., Pullirsch D; The Austrian Agency for Health and Food Safety (AGES), Austria., Sanyal G; Vaccine Analytics, LLC, USA., Shi L; Shanghai Zerun Biotechnology Company, China., Sitrin R; PATH, USA., Smith D; Health Canada, Canada., Stickings P; The National Institute for Biological Standards and Control (NIBSC), United Kingdom., Terao E; European Directorate for the Quality of Medicines & Healthcare (EDQM), France., Uhlrich S; Sanofi Pasteur, France., Viviani L; Independent Consultant, Humane Society International, Switzerland. Electronic address: vivianilaur@gmail.com., Webster J; World Organization for Animal Health (OIE), New Zealand.

Publikováno v: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 Nov; Vol. 68, pp. 92-107. Date of Electronic Publication: 2020 Oct 08.

Effect of Aluminum Adjuvant and Preservatives on Structural Integrity and Physicochemical Stability Profiles of Three Recombinant Subunit Rotavirus Vaccine Antigens.

Autor: Agarwal S; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, Kansas 66047., Hickey JM; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, Kansas 66047., McAdams D; The Center for Vaccine Innovation and Access, PATH, Seattle, Washington 98121., White JA; The Center for Vaccine Innovation and Access, PATH, Seattle, Washington 98121., Sitrin R; The Center for Vaccine Innovation and Access, PATH, Washington, District of Columbia 20001., Khandke L; The Center for Vaccine Innovation and Access, PATH, Washington, District of Columbia 20001., Cryz S; The Center for Vaccine Innovation and Access, PATH, Washington, District of Columbia 20001., Joshi SB; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, Kansas 66047., Volkin DB; Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, Kansas 66047. Electronic address: volkin@ku.edu.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2020 Jan; Vol. 109 (1), pp. 476-487. Date of Electronic Publication: 2019 Oct 04.