Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working Group
Vaccine candidates for <i>Shigella</i> are approaching phase 3 clinical trials in the target population of young children living in low- and middle-income countries. Key study design decisions will need to be made to maximize the success of such trials and minimize the time to licensure...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-03-01
|
| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/10/4/489 |
| _version_ | 1797443367416627200 |
|---|---|
| author | Patricia B. Pavlinac Elizabeth T. Rogawski McQuade James A. Platts-Mills Karen L. Kotloff Carolyn Deal Birgitte K. Giersing Richard A. Isbrucker Gagandeep Kang Lyou-Fu Ma Calman A. MacLennan Peter Patriarca Duncan Steele Kirsten S. Vannice |
| author_facet | Patricia B. Pavlinac Elizabeth T. Rogawski McQuade James A. Platts-Mills Karen L. Kotloff Carolyn Deal Birgitte K. Giersing Richard A. Isbrucker Gagandeep Kang Lyou-Fu Ma Calman A. MacLennan Peter Patriarca Duncan Steele Kirsten S. Vannice |
| author_sort | Patricia B. Pavlinac |
| collection | DOAJ |
| description | Vaccine candidates for <i>Shigella</i> are approaching phase 3 clinical trials in the target population of young children living in low- and middle-income countries. Key study design decisions will need to be made to maximize the success of such trials and minimize the time to licensure and implementation. We convened an ad hoc working group to identify the key aspects of trial design that would meet the regulatory requirements to achieve the desired indication of prevention of moderate or severe shigellosis due to strains included in the vaccine. The proposed primary endpoint of pivotal <i>Shigella</i> vaccine trials is the efficacy of the vaccine against the first episode of acute moderate or severe diarrhea caused by the <i>Shigella</i> strains contained within the vaccine. Moderate or severe shigellosis could be defined by a modified Vesikari score with dysentery and molecular detection of vaccine-preventable <i>Shigella</i> strains. This report summarizes the rationale and current data behind these considerations, which will evolve as new data become available and after further review and consultation by global regulators and policymakers. |
| first_indexed | 2024-03-09T12:54:56Z |
| format | Article |
| id | doaj.art-7b3e5533178c4f4590b2b6df4fc7d8c0 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T12:54:56Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-7b3e5533178c4f4590b2b6df4fc7d8c02023-11-30T22:01:41ZengMDPI AGVaccines2076-393X2022-03-0110448910.3390/vaccines10040489Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working GroupPatricia B. Pavlinac0Elizabeth T. Rogawski McQuade1James A. Platts-Mills2Karen L. Kotloff3Carolyn Deal4Birgitte K. Giersing5Richard A. Isbrucker6Gagandeep Kang7Lyou-Fu Ma8Calman A. MacLennan9Peter Patriarca10Duncan Steele11Kirsten S. Vannice12Departments of Global Health and Epidemiology, University of Washington, Seattle, WA 98105, USADepartment of Epidemiology, Emory University, Atlanta, GA 30322, USADepartment of Medicine, Infectious Diseases and International Health, University of Virginia, Charlottesville, VA 22908, USADepartment of Pediatrics, Medicine, Epidemiology, and Public Health, University of Maryland, Baltimore, MD 21201, USAEnteric and Sexually Transmitted Infections Branch, National Institutes of Health, Rockvile, MD 20892, USAImmunization, Vaccines, and Biologicals Department, World Health Organization, 1211 Geneva, SwitzerlandImmunization, Vaccines, and Biologicals Department, World Health Organization, 1211 Geneva, SwitzerlandDepartment of Gastrointestinal Sciences, Christian Medical College, Vellore 632004, Tamil Nadu, IndiaEnteric and Diarrheal Diseases Program Strategy Team, Bill & Melinda Gates Foundation, Seattle, WA 98102, USAEnteric and Diarrheal Diseases Program Strategy Team, Bill & Melinda Gates Foundation, Seattle, WA 98102, USABill & Melinda Gates Medical Research Institute, Cambridge, MA 02139, USAEnteric and Diarrheal Diseases Program Strategy Team, Bill & Melinda Gates Foundation, Seattle, WA 98102, USAEnteric and Diarrheal Diseases Program Strategy Team, Bill & Melinda Gates Foundation, Seattle, WA 98102, USAVaccine candidates for <i>Shigella</i> are approaching phase 3 clinical trials in the target population of young children living in low- and middle-income countries. Key study design decisions will need to be made to maximize the success of such trials and minimize the time to licensure and implementation. We convened an ad hoc working group to identify the key aspects of trial design that would meet the regulatory requirements to achieve the desired indication of prevention of moderate or severe shigellosis due to strains included in the vaccine. The proposed primary endpoint of pivotal <i>Shigella</i> vaccine trials is the efficacy of the vaccine against the first episode of acute moderate or severe diarrhea caused by the <i>Shigella</i> strains contained within the vaccine. Moderate or severe shigellosis could be defined by a modified Vesikari score with dysentery and molecular detection of vaccine-preventable <i>Shigella</i> strains. This report summarizes the rationale and current data behind these considerations, which will evolve as new data become available and after further review and consultation by global regulators and policymakers.https://www.mdpi.com/2076-393X/10/4/489vaccine trial designpediatricslow and middle-income countries<i>Shigella</i> |
| spellingShingle | Patricia B. Pavlinac Elizabeth T. Rogawski McQuade James A. Platts-Mills Karen L. Kotloff Carolyn Deal Birgitte K. Giersing Richard A. Isbrucker Gagandeep Kang Lyou-Fu Ma Calman A. MacLennan Peter Patriarca Duncan Steele Kirsten S. Vannice Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working Group Vaccines vaccine trial design pediatrics low and middle-income countries <i>Shigella</i> |
| title | Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working Group |
| title_full | Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working Group |
| title_fullStr | Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working Group |
| title_full_unstemmed | Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working Group |
| title_short | Pivotal <i>Shigella</i> Vaccine Efficacy Trials—Study Design Considerations from a <i>Shigella</i> Vaccine Trial Design Working Group |
| title_sort | pivotal i shigella i vaccine efficacy trials study design considerations from a i shigella i vaccine trial design working group |
| topic | vaccine trial design pediatrics low and middle-income countries <i>Shigella</i> |
| url | https://www.mdpi.com/2076-393X/10/4/489 |
| work_keys_str_mv | AT patriciabpavlinac pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT elizabethtrogawskimcquade pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT jamesaplattsmills pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT karenlkotloff pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT carolyndeal pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT birgittekgiersing pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT richardaisbrucker pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT gagandeepkang pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT lyoufuma pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT calmanamaclennan pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT peterpatriarca pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT duncansteele pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup AT kirstensvannice pivotalishigellaivaccineefficacytrialsstudydesignconsiderationsfromaishigellaivaccinetrialdesignworkinggroup |