Show simple item record

dc.contributor.authorSekuloski, Silvana
dc.contributor.authorBatzloff, Michael R
dc.contributor.authorGriffin, Paul
dc.contributor.authorParsonage, William
dc.contributor.authorElliott, Suzanne
dc.contributor.authorHartas, Jon
dc.contributor.authorO'Rourke, Peter
dc.contributor.authorMarquart, Louise
dc.contributor.authorPandey, Manisha
dc.contributor.authorRubin, Fran A
dc.contributor.authorCarapetis, Jonathan
dc.contributor.authorMcCarthy, James
dc.contributor.authorGood, Michael F
dc.date.accessioned2019-07-05T12:32:18Z
dc.date.available2019-07-05T12:32:18Z
dc.date.issued2018
dc.identifier.issn1932-6203
dc.identifier.doi10.1371/journal.pone.0198658
dc.identifier.urihttp://hdl.handle.net/10072/383798
dc.description.abstractBackground: Group A streptococcus (GAS) is a serious human pathogen that affects people of different ages and socio-economic levels. Although vaccination is potentially one of the most effective methods to control GAS infection and its sequelae, few prototype vaccines have been investigated in humans. In this study, we report the safety and immunogenicity of a novel acetylated peptide-protein conjugate vaccine candidate MJ8VAX (J8-DT), when delivered intramuscularly to healthy adults. Methods: A randomized, double-blinded, controlled Phase I clinical trial was conducted in 10 healthy adult participants. Participants were randomized 4:1 to receive the vaccine candidate (N = 8) or placebo (N = 2). A single dose of the vaccine candidate (MJ8VAX), contained 50 μg of peptide conjugate (J8-DT) adsorbed onto aluminium hydroxide and re-suspended in PBS in a total volume of 0.5 mL. Safety of the vaccine candidate was assessed by monitoring local and systemic adverse reactions following intramuscular administration. The immunogenicity of the vaccine was assessed by measuring the levels of peptide (anti-J8) and toxoid carrier (anti-DT)—specific antibodies in serum samples. Results: No serious adverse events were reported over 12 months of study. A total of 13 adverse events (AEs) were recorded, two of which were assessed to be associated with the vaccine. Both were mild in severity. No local reactogenicity was recorded in any of the participants. MJ8VAX was shown to be immunogenic, with increase in vaccine-specific antibodies in the participants who received the vaccine. The maximum level of vaccine-specific antibodies was detected at 28 days post immunization. The level of these antibodies decreased with time during follow-up. Participants who received the vaccine also had a corresponding increase in anti-DT serum antibodies. Conclusions: Intramuscular administration of MJ8VAX was demonstrated to be safe and immunogenic. The presence of DT in the vaccine formulation resulted in a boost in the level of anti-DT antibodies.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherPUBLIC LIBRARY SCIENCE
dc.relation.ispartofissue7
dc.relation.ispartofjournalPLOS ONE
dc.relation.ispartofvolume13
dc.subject.fieldofresearchBacteriology
dc.subject.fieldofresearchcode310701
dc.titleEvaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© 2018 Sekuloski et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
gro.hasfulltextFull Text
gro.griffith.authorGood, Michael F.
gro.griffith.authorPandey, Manisha


Files in this item

This item appears in the following Collection(s)

  • Journal articles
    Contains articles published by Griffith authors in scholarly journals.

Show simple item record