Evidence map›Paper›PMID 19151191›Full record

ArticleAmerican journal of respiratory and critical care medicine2009

Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in Mycobacterium tuberculosis-infected individuals.

Clare R Sander, Ansar A Pathan, Natalie E R Beveridge, Ian Poulton, Angela Minassian, Nicola Alder, Johan Van Wijgerden, Adrian V S Hill, Fergus V Gleeson, Robert J O Davies and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in American journal of respiratory and critical care medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00456183 (A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis.), which is not on this map. Cited by 65 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 2 pooled it
10.7field-weighted citation impact, top 1% 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.

NCT00456183 phase1completednot on this map

A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis.

TypeinterventionalSponsorUniversity of OxfordRan2005 to 2007Enrolled12ConditionsTuberculosisArmsMVA 85A
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 2 syntheses or guidelines pooled it, 122 citations in OpenAlex.

  1. Pooled it
  2. MVA85A vaccine to enhance BCG for preventing tuberculosis.The Cochrane database of systematic reviews · 2019
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  17. Review
  18. An Update on Tuberculosis Vaccines.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  19. Article
  20. Tuberculosis vaccine development: from classic to clinical candidates.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Review

5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Clare R SanderCentre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford OX3 7LJ, UK.
Ansar A Pathan
Natalie E R Beveridge
Ian Poulton
Angela Minassian
Nicola Alder
Johan Van Wijgerden
Adrian V S Hill
Fergus V Gleeson
Robert J O Davies
Geoffrey Pasvol
Helen McShane
Churchill Hospital · GBOxford Centre for Diabetes, Endocrinology and Metabolism · GBEaling Hospital · GBNorthwick Park Hospital · GBUniversity of Oxford · GB

Funding

Wellcome Trust 076943
6 · The paper itself

Abstract

rationaleAn effective new tuberculosis (TB) vaccine regimen must be safe in individuals with latent TB infection (LTBI) and is a priority for global health care.

objectivesTo evaluate the safety and immunogenicity of a leading new TB vaccine, recombinant Modified Vaccinia Ankara expressing Antigen 85A (MVA85A) in individuals with LTBI.

methodsAn open-label, phase I trial of MVA85A was performed in 12 subjects with LTBI recruited from TB contact clinics in Oxford and London or by poster advertisements in Oxford hospitals. Patients were assessed clinically and had blood samples drawn for immunological analysis over a 52-week period after vaccination with MVA85A. Thoracic computed tomography scans were performed at baseline and at 10 weeks after vaccination. Safety of MVA85A was assessed by clinical, radiological, and inflammatory markers. The immunogenicity of MVA85A was assessed by IFNgamma and IL-2 ELISpot assays and FACS. MEASUREMENTS AND MAIN

resultsMVA85A was safe in subjects with LTBI, with comparable adverse events to previous trials of MVA85A. There were no clinically significant changes in inflammatory markers or thoracic computed tomography scans after vaccination. MVA85A induced a strong antigen-specific IFN-gamma and IL-2 response that was durable for 52 weeks. The magnitude of IFN-gamma response was comparable to previous trials of MVA85A in bacillus Calmette-Guérin-vaccinated individuals. Antigen 85A-specific polyfunctional CD4(+) T cells were detectable prior to vaccination with statistically significant increases in cell numbers after vaccination.

conclusionsMVA85A is safe and highly immunogenic in individuals with LTBI. These results will facilitate further trials in TB-endemic areas. Clinical trial registered with www.clinicaltrials.gov (NCT00456183).

Indexed as

AdultFemaleHumansMaleMiddle AgedMycobacterium tuberculosisTuberculin TestTuberculosisTuberculosis VaccinesVaccines, SyntheticYoung AdultTuberculosis VaccinesVaccines, Synthetic

Identifiers

PMID19151191
PMCPMC2858810
OpenAlexW2143296217

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.