دورية أكاديمية
Salmonella Vaccine Study in Oxford (SALVO) trial: protocol for an observer-participant blind randomised placebo-controlled trial of the iNTS-GMMA vaccine within a European cohort
| العنوان: | Salmonella Vaccine Study in Oxford (SALVO) trial: protocol for an observer-participant blind randomised placebo-controlled trial of the iNTS-GMMA vaccine within a European cohort |
|---|---|
| المؤلفون: | Melita A Gordon, Ellis Owusu-Dabo, Florian Marks, Carsten Mantel, Andrew J Pollard, Brama Hanumunthadu, Rachel White, John A Crump, Hannah Robinson, Jan Jacobs, Samuel Kariuki, Bieke Tack, Stefano Malvolti, Nasir Kanji, Nelly Owino, Carla Ferreira Da Silva, Pietro Ferruzzi, Usman Nakakana, Rocio Canals, Maheshi Ramasamy, Francis Agyapong, Gianluca Breghi, Fabio Fiorino, Christian S. Marchello, Donata Medaglini, Esther M. Muthumbi, Chisomo L. Msefula, Tonney S. Nyirenda, Robert Onsare, Elena Pettini, Anthony G Scott J, Bassiahi Abdramane Soura, Tiziana Spadafina |
| المصدر: | BMJ Open, Vol 13, Iss 11 (2023) |
| بيانات النشر: | BMJ Publishing Group, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Medicine |
| مصطلحات موضوعية: | Medicine |
| الوصف: | Introduction Invasive non-typhoidal Salmonellosis (iNTS) is mainly caused by Salmonella enterica serovars Typhimurium and Enteritidis and is estimated to result in 77 500 deaths per year, disproportionately affecting children under 5 years of age in sub-Saharan Africa. Invasive non-typhoidal Salmonellae serovars are increasingly acquiring resistance to first-line antibiotics, thus an effective vaccine would be a valuable tool in reducing morbidity and mortality from infection. While NTS livestock vaccines are in wide use, no licensed vaccines exist for use in humans. Here, a first-in-human study of a novel vaccine (iNTS-GMMA) containing S. Typhimurium and S. Enteritidis Generalised Modules for Membrane Antigens (GMMA) outer membrane vesicles is presented.Method and analysis The Salmonella Vaccine Study in Oxford is a randomised placebo-controlled participant-observer blind phase I study of the iNTS-GMMA vaccine. Healthy adult volunteers will be randomised to receive three intramuscular injections of the iNTS-GMMA vaccine, containing equal quantities of S. Typhimurium and S. Enteritidis GMMA particles adsorbed on Alhydrogel, or an Alhydrogel placebo at 0, 2 and 6 months. Participants will be sequentially enrolled into three groups: group 1, 1:1 randomisation to low dose iNTS-GMMA vaccine or placebo; group 2, 1:1 randomisation to full dose iNTS-GMMA vaccine or placebo; group 3, 2:1 randomisation to full dose or lower dose (dependant on DSMC reviews of groups 1 and 2) iNTS-GMMA vaccine or placebo.The primary objective is safety and tolerability of the vaccine. The secondary objective is immunogenicity as measured by O-antigen based ELISA. Further exploratory objectives will characterise the expanded human immune profile.Ethics and dissemination Ethical approval for this study has been obtained from the South Central—Oxford A Research Ethics Committee (Ethics REF:22/SC/0059). Appropriate documentation and regulatory approvals have been acquired. Results will be disseminated via peer-reviewed articles and conferences.Trial registration number EudraCT Number: 2020-000510-14. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2023-0729 2044-6055 |
| العلاقة: | https://bmjopen.bmj.com/content/13/11/e072938.fullTest; https://doaj.org/toc/2044-6055Test |
| DOI: | 10.1136/bmjopen-2023-072938 |
| الوصول الحر: | https://doaj.org/article/7f29c2eaf5e042f4a8bfa23fb84777a2Test |
| رقم الانضمام: | edsdoj.7f29c2eaf5e042f4a8bfa23fb84777a2 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 20230729 20446055 |
|---|---|
| DOI: | 10.1136/bmjopen-2023-072938 |