Evidence map›Paper›PMID 37232372›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring.

Edwin J Asturias, Jean-Louis Excler, James Ackland, Marco Cavaleri, Alma Fulurija, Raj Long, Mignon McCulloch, Shiranee Sriskandan, Wellington Sun, Liesl Zühlke and 3 more

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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

10 citing papers in PubMed.

  1. Review
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  3. Article
  4. Article
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  9. Vaccines · 2023
    Review
  10. Article
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.

Edwin J AsturiasColorado School of Public Health, University of Colorado, Aurora Colorado, USA.
Jean-Louis ExclerDirector General's Office, International Vaccine Institute, Seoul, Republic of Korea.ORCID 0000-0002-6462-5101
James AcklandGlobal BioSolutions, Melbourne, Australia.
Marco CavaleriAnti-Infectives and Vaccines, European Medicines Agency, Amsterdam, The Netherlands.
Alma FulurijaGroup A Streptococcal and Rheumatic Heart Disease Team, Telethon Kids Institute, Perth, Australia.
Raj LongSafety and pharmacovigilance, Bill & Melinda Gates Foundation, London, United Kingdom.
Mignon McCullochDepartment of Paediatrics, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa.
Shiranee SriskandanDepartment of Infectious Diseases, Imperial College, London, United Kingdom.
Wellington SunVaxcellerant LLC, Silver Spring Maryland, USA.
Liesl ZühlkeSouth African Medical Research Council, Parowvallei, Cape Town, South Africa.ORCID 0000-0003-3961-2760
Jerome H KimDirector General's Office, International Vaccine Institute, Seoul, Republic of Korea.
James B DaleCollege of Medicine, University of Tennessee Health Science Center, Memphis Tennessee, USA.
Andrew C SteerInfection and Immunity Theme, Tropical Diseases Research Group, Murdoch Children's Research Institute, Parkville Victoria, Australia.

Funding

Wellcome Trust 215490/Z/19/Z
6 · The paper itself

Abstract

Streptococcus pyogenes (Strep A) infections result in a vastly underestimated burden of acute and chronic disease globally. The Strep A Vaccine Global Consortium's (SAVAC's) mission is to accelerate the development of safe, effective, and affordable S. pyogenes vaccines. The safety of vaccine recipients is of paramount importance. A single S. pyogenes vaccine clinical trial conducted in the 1960s raised important safety concerns. A SAVAC Safety Working Group was established to review the safety assessment methodology and results of more recent early-phase clinical trials and to consider future challenges for vaccine safety assessments across all phases of vaccine development. No clinical or biological safety signals were detected in any of these early-phase trials in the modern era. Improvements in vaccine safety assessments need further consideration, particularly for pediatric clinical trials, large-scale efficacy trials, and preparation for post-marketing pharmacovigilance.

Indexed as

Streptococcal InfectionsStreptococcal VaccinesChildClinical Trials as TopicHumansStreptococcus pyogenesStreptococcal Vaccinesacute rheumatic feverclinical trialsafetyStreptococcus pyogenesvaccine

Identifiers

PMID37232372
PMCPMC10506775

What OpenQuestion holds

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LicenceCC BY
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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.