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
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
BMJ open - 13(2023), 11 vom: 14. Nov., Seite e072938 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hanumunthadu, Brama [VerfasserIn] |
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| Links: |
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| Themen: |
5QB0T2IUN0 |
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| Anmerkungen: |
Date Completed 16.11.2023 Date Revised 10.02.2024 published: Electronic EudraCT: 2020-000510-14 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2023-072938 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364553111 |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: EudraCT Number: 2020-000510-14 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
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| 700 | 1 | |a Pollard, Andrew J |e verfasserin |4 aut | |
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| 700 | 0 | |a Vacc-iNTS Consortium |e verfasserin |4 aut | |
| 700 | 1 | |a Agyapong, Francis |e investigator |4 oth | |
| 700 | 1 | |a Breghi, Gianluca |e investigator |4 oth | |
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| 700 | 1 | |a Fiorino, Fabio |e investigator |4 oth | |
| 700 | 1 | |a Gordon, Melita A |e investigator |4 oth | |
| 700 | 1 | |a Jacobs, Jan |e investigator |4 oth | |
| 700 | 1 | |a Kariuki, Samuel |e investigator |4 oth | |
| 700 | 1 | |a Malvolti, Stefano |e investigator |4 oth | |
| 700 | 1 | |a Mantel, Carsten |e investigator |4 oth | |
| 700 | 1 | |a Marchello, Christian S |e investigator |4 oth | |
| 700 | 1 | |a Marks, Florian |e investigator |4 oth | |
| 700 | 1 | |a Medaglini, Donata |e investigator |4 oth | |
| 700 | 1 | |a Muthumbi, Esther M |e investigator |4 oth | |
| 700 | 1 | |a Msefula, Chisomo L |e investigator |4 oth | |
| 700 | 1 | |a Nyirenda, Tonney S |e investigator |4 oth | |
| 700 | 1 | |a Onsare, Robert |e investigator |4 oth | |
| 700 | 1 | |a Owusu-Dabo, Ellis |e investigator |4 oth | |
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| 700 | 1 | |a J, Anthony G Scott |e investigator |4 oth | |
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