Evidence map›Paper›PMID 36442498›Full record

Trial reportThe Lancet. Global health2023

Typhoid conjugate vaccine effectiveness in Malawi: evaluation of a test-negative design using randomised, controlled clinical trial data.

Yuanyuan Liang, Amanda J Driscoll, Priyanka D Patel, Shrimati Datta, Merryn Voysey, Neil French, Leslie P Jamka, Marc Y R Henrion, Latif Ndeketa, Matthew B Laurens and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Global health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07416461 (Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT07416461 recruitingnot on this mapstarted 2025, after this paper: background citation

Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)

TypeobservationalSponsorInternational Vaccine InstituteRan2025 to 2027Enrolled10,000ConditionsInvasive Non-Typhoidal Salmonella Disease, Malaria, Malaria VaccineArmsR21/Matrix-M malaria vaccine
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Programmatic Effectiveness of a Pediatric Typhoid Conjugate Vaccine Campaign in Navi Mumbai, India.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Vaccination to Reduce Antimicrobial Resistance Burden-Data Gaps and Future Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  10. Article
  11. Article
  12. 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.

Yuanyuan LiangDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Amanda J DriscollCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Priyanka D PatelMalawi-Liverpool-Wellcome Programme, Kamuzu University of Health Sciences, Blantyre, Malawi.
Shrimati DattaCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Merryn VoyseyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Neil FrenchInstitute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.
Leslie P JamkaCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Marc Y R HenrionMalawi-Liverpool-Wellcome Programme, Kamuzu University of Health Sciences, Blantyre, Malawi.
Latif NdeketaMalawi-Liverpool-Wellcome Programme, Kamuzu University of Health Sciences, Blantyre, Malawi.
Matthew B LaurensCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Robert S HeydermanDivision of Infection and Immunity, University College London, London, UK.
Melita A GordonMalawi-Liverpool-Wellcome Programme, Kamuzu University of Health Sciences, Blantyre, Malawi; Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: kneuzil@som.umaryland.edu.

Funding

FELLOWSHIP TRAINING PROGRAM IN VACCINOLOGYT32AI007524 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Marcelo B. Sztein · 1997 to 2026
$6.4M
Department of Health NIHR300039NIAID NIH HHS T32 AI007524Wellcome Trust 206545/Z/17/Z
6 · The paper itself

Abstract

backgroundTyphoid conjugate vaccines are being introduced in low-income and middle-income countries to prevent typhoid illness in children. Vaccine effectiveness studies assess vaccine performance after introduction. The test-negative design is a commonly used method to estimate vaccine effectiveness that has not been applied to typhoid vaccines because of concerns over blood culture insensitivity. The overall aim of the study was to evaluate the appropriateness of using a test-negative design to assess typhoid Vi polysaccharide-tetanus toxoid conjugate vaccine (Vi-TT) effectiveness using a gold standard randomised controlled trial database.

methodsUsing blood culture data from a randomised controlled trial of Vi-TT in Malawi, we simulated a test-negative design to derive vaccine effectiveness estimates using three different approaches and compared these to randomised trial efficacy results. In the randomised trial, 27 882 children aged 9 months to 12 years were randomly assigned (1:1) to receive a single dose of Vi-TT or meningococcal capsular group A conjugate vaccine between Feb 21 and Sept 27, 2018, and were followed up for blood culture-confirmed typhoid fever until Sept 30, 2021.

findingsFor all three test-negative design approaches, vaccine effectiveness estimates (test-negative design A, 80·3% [95% CI 66·2 to 88·5] vs test-negative design B, 80·5% [66·5 to 88·6] vs test-negative design C, 80·4% [66·9 to 88·4]) were almost identical to the randomised trial results (80·4% [95% CI 66·4 to 88·5]). Receipt of Vi-TT did not affect the risk of non-typhoid fever (vaccine efficacy against non-typhoid fever -0·4% [95% CI -4·9 to 3·9] vs -1% [-5·6 to 3·3] vs -2·5% [-6·4 to 1·3] for test-negative design A, test-negative design B, and test-negative design C, respectively).

interpretationThis study validates the test-negative design core assumption for typhoid vaccine effectiveness estimation and shows the accuracy and precision of the estimates compared with the randomised controlled trial. These results show that the test-negative design is suitable for assessing typhoid conjugate vaccine effectiveness in post-introduction studies using blood culture surveillance.

fundingBill & Melinda Gates Foundation.

Indexed as

Typhoid FeverTyphoid-Paratyphoid VaccinesChildHumansMalawiSalmonella typhiVaccine EfficacyVaccines, ConjugateTyphoid-Paratyphoid VaccinesVaccines, Conjugate

Identifiers

PMID36442498
PMCPMC9748309

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Registered trials

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.