Evidence map›Paper›PMID 29965967›Full record

Trial reportPloS one2018

Evaluation of safety and immunogenicity of a group A streptococcus vaccine candidate (MJ8VAX) in a randomized clinical trial.

Silvana Sekuloski, Michael R Batzloff, Paul Griffin, William Parsonage, Suzanne Elliott, Jon Hartas, Peter O'Rourke, Louise Marquart, Manisha Pandey, Fran A Rubin and 3 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed
7.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 82 citations in OpenAlex.

  1. Article
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  6. Tracking Canada's 2015 vaccine research and development priorities: Where are we a decade later?Canada communicable disease report = Releve des maladies transmissibles au Canada · 2026
    Article
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  8. M1 protein from group ABlood vessels, thrombosis & hemostasis · 2025
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 2 countries.

Silvana SekuloskiClinical Tropical Medicine Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, Australia.
Michael R BatzloffThe Institute for Glycomics, Griffith University, Gold Coast, Queensland, Australia.ORCID 0000-0003-0482-0033
Paul GriffinClinical Tropical Medicine Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, Australia.
William ParsonageAustralian Centre for Health Service Innovation, Queensland University of Technology, Brisbane, Australia.
Suzanne ElliottQ-Pharm Pty Ltd, Brisbane, Australia.
Jon HartasThe Institute for Glycomics, Griffith University, Gold Coast, Queensland, Australia.
Peter O'RourkeClinical Tropical Medicine Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, Australia.
Louise MarquartClinical Tropical Medicine Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, Australia.
Manisha PandeyThe Institute for Glycomics, Griffith University, Gold Coast, Queensland, Australia.
Fran A RubinDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Jonathan CarapetisTelethon Kids Institute, University of Western Australia and Perth Children's Hospital, Perth, Australia.
James McCarthyClinical Tropical Medicine Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, Australia.
Michael F GoodThe Institute for Glycomics, Griffith University, Gold Coast, Queensland, Australia.
Griffith University · AUQIMR Berghofer Medical Research Institute · AUThe University of Queensland · AUNational Institutes of Health · USQ-Pharm · AUQueensland University of Technology · AUThe Kids Research Institute Australia · AU

Funding

Global GAS Vaccine Based On The M-ProteinU01AI060579 · NIAID · QUEENSLAND INSTITUTE OF MEDICAL RESEARCH · PI GOOD, MICHAEL F · 2004 to 2008
$2.8M
NIAID NIH HHS U01 AI060579
6 · The paper itself

Abstract

backgroundGroup 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.

methodsA 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.

resultsNo 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.

conclusionsIntramuscular 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.

trial registrationACTRN12613000030774.

Indexed as

AdolescentAdultDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMiddle AgedStreptococcal InfectionsStreptococcal VaccinesStreptococcus pyogenesVaccinationVaccines, ConjugateStreptococcal VaccinesVaccines, Conjugate

Identifiers

PMID29965967
PMCPMC6028081
OpenAlexW2809702354

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.