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Hanumunthadu, Brama; Kanji, Nasir; Owino, Nelly; Ferreira Da Silva, Carla; Robinson, Hannah; White, Rachel; Ferruzzi, Pietro; Nakakana, Usman; Canals, Rocio; Pollard, Andrew J; Ramasamy, Maheshi; Agyapong, Francis; Breghi, Gianluca; Crump, John A; Fiorino, Fabio; Gordon, Melita A; Jacobs, Jan; Kariuki, Samuel; Malvolti, Stefano; Mantel, Carsten; Marchello, Christian S.; Marks, Florian; Medaglini, Donata; Muthumbi, Esther M.; Msefula, Chisomo L.; Nyirenda, Tonney S.; Onsare, Robert; Owusu-Dabo, Ellis; Pettini, Elena; J, Anthony G Scott; Soura, Bassiahi Abdramane; Spadafina, Tiziana; Tack, Bieke
BMJ open, 11/2023, Letnik: 13, Številka: 11Journal Article
IntroductionInvasive 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 analysisThe 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 disseminationEthical 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 numberEudraCT Number: 2020-000510-14.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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