Evidence map›Paper›PMID 31031031›Full record

ReviewVaccine2019

The role of immune correlates of protection on the pathway to licensure, policy decision and use of group B Streptococcus vaccines for maternal immunization: considerations from World Health Organization consultations.

Johan Vekemans, Jonathan Crofts, Carol J Baker, David Goldblatt, Paul T Heath, Shabir A Madhi, Kirsty Le Doare, Nick Andrews, Andrew J Pollard, Samir K Saha and 3 more

Open access · hybridAbstract readReview
In one paragraph

Review in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
5.5field-weighted citation impact, top 4% 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

35 citing papers in PubMed, 55 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. NovelmBio · 2025
    Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Emergence of High-Level Gentamicin Resistance inAntibiotics (Basel, Switzerland) · 2024
    Article
  11. Article
  12. Neonatal Group B Streptococcus Disease.Pediatrics in review · 2024
    Review
  13. Article
  14. Vaccines forFrontiers in immunology · 2024
    Review
  15. Preparing for Group BHuman vaccines & immunotherapeutics · 2023
    Article
  16. Article
  17. Strategies to Prevent Early and Late-Onset Group BPathogens (Basel, Switzerland) · 2023
    Review
  18. Article
  19. Article
  20. 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 at 11 institutions in 6 countries.

Johan VekemansInitiative for Vaccine Research, World Health Organization, 20 Av Appia, 1202 Geneva, Switzerland. Electronic address: vekemansj@who.int.
Jonathan CroftsJoint Committee on Vaccination and Immunisation, Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, UK. Electronic address: jonathan.crofts@phe.gov.uk.
Carol J BakerDivision of Pediatric Infectious Diseases, University of Texas McGovern Medical School., 6431 Fannin Street, MSB 3.126, Houston, TX 77030, USA.
David GoldblattInstitute of Child Health, University College London, 30 Guilford St, London WC1N 1EH, UK. Electronic address: d.goldblatt@ucl.ac.uk.
Paul T HeathInstitute of Infection and Immunity, St George's University of London, Cranmer Terrace, London SW17 0RE, UK. Electronic address: pheath@sgul.ac.uk.
Shabir A MadhiMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, 2193 Johannesburg, South Africa. Electronic address: madhis@rmpru.co.za.
Kirsty Le DoareInstitute of Infection and Immunity, St George's University of London, Cranmer Terrace, London SW17 0RE, UK. Electronic address: kiledoar@sgul.ac.uk.
Nick AndrewsStatistics Unit, Public Health England, 61 Colindale Av., London NW9 5EQ, UK. Electronic address: nick.andrews@phe.gov.uk.
Andrew J PollardOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford OX3 9DU, UK. Electronic address: andrew.pollard@paediatrics.ox.ac.uk.
Samir K SahaThe Child Health Research Foundation at the Bangladesh Institute of Child Health, Sher-E-Banglanagar, Dhaka Shishu Hospital, Dhaka 1207, Bangladesh.
Stephanie J SchragRespiratory Diseases Branch, Division of Bacterial Diseases at the Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta 30333, USA. Electronic address: zha6@cdc.gov.
Peter G SmithTropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK. Electronic address: p.smith@lshtm.ac.uk.
David C KaslowPATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA. Electronic address: dkaslow@path.org.
Public Health England · GBSt George's, University of London · GBBangladesh Shishu (Children) Hospital & Institute · BDCenters for Disease Control and Prevention · USInstitute of Child Health · GRLondon School of Hygiene & Tropical Medicine · GBProgram for Appropriate Technology in Health · USThe University of Texas Health Science Center at Houston · USUniversity of Oxford · GBUniversity of the Witwatersrand · ZAWorld Health Organization · CH

Funding

Medical Research Council MC_PC_17221Medical Research Council MC_UU_00026/2Medical Research Council MR/R005990/1Medical Research Council MR/R005990/2Medical Research Council MR/R010161/1World Health Organization 001
6 · The paper itself

Abstract

The development of a group B Streptococcus (GBS) vaccine for maternal immunization constitutes a global public health priority, to prevent GBS-associated early life invasive disease, stillbirth, premature birth, maternal sepsis, adverse neurodevelopmental consequences, and to reduce perinatal antibiotic use. Sample size requirements for the conduct of a randomized placebo-controlled trial to assess vaccine efficacy against the most relevant clinical endpoints, under conditions of appropriate ethical standards of care, constitute a significant obstacle on the pathway to vaccine availability. Alternatively, indirect evidence of protection based on immunologic data from vaccine and sero-epidemiological studies, complemented by data from opsonophagocytic in vitro assays and animal models, could be considered as pivotal data for licensure, with subsequent confirmation of effectiveness against disease outcomes in post-licensure evaluations. Based on discussions initiated by the World Health Organization we present key considerations about the potential role of correlates of protection towards an accelerated pathway for GBS vaccine licensure and wide scale use. Priority activities to support progress to regulatory and policy decision are outlined.

Indexed as

World Health OrganizationCost-Benefit AnalysisDrug ApprovalFemaleHumansInfant, NewbornInfant, Newborn, DiseasesMaternal HealthPregnancyPregnancy Complications, InfectiousPremature BirthStillbirthStreptococcal InfectionsStreptococcal VaccinesStreptococcus agalactiaeVaccinationStreptococcal VaccinesCorrelates of protectionGroup B StreptococcusMaternal immunizationNeonatal sepsisVaccines

Identifiers

PMID31031031
PMCPMC6528168
OpenAlexW2941444953

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.