Evidence map›Paper›PMID 22281831›Full record

Trial reportAmerican journal of respiratory and critical care medicine2012

A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults.

Thomas J Scriba, Michele Tameris, Erica Smit, Linda van der Merwe, E Jane Hughes, Blessing Kadira, Katya Mauff, Sizulu Moyo, Nathaniel Brittain, Alison Lawrie and 14 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
7.4field-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

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. MVA85A vaccine to enhance BCG for preventing tuberculosis.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Vaccine against tuberculosis: what's new?BMC infectious diseases · 2014
    Pooled it
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  13. Observational
  14. Dominant CD4Cell reports. Medicine · 2023
    Article
  15. Review
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  17. Article
  18. Article
  19. mBio · 2022
    Article
  20. An Update on Tuberculosis Vaccines.Methods in molecular biology (Clifton, N.J.) · 2022
    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

24 authors at 3 institutions in 3 countries.

Thomas J ScribaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and School of Child and Adolescent Health, University of Cape Town, Cape Town, South Africa. thomas.scriba@uct.ac.za
Michele Tameris
Erica Smit
Linda van der Merwe
E Jane Hughes
Blessing Kadira
Katya Mauff
Sizulu Moyo
Nathaniel Brittain
Alison Lawrie
Humphrey Mulenga
Marwou de Kock
Lebohang Makhethe
Esme Janse van Rensburg
Sebastian Gelderbloem
Ashley Veldsman
Mark Hatherill
Hendrik Geldenhuys
Adrian V S Hill
Anthony Hawkridge
Gregory D Hussey
Willem A Hanekom
Helen McShane
Hassan Mahomed
TuBerculosis Vaccine Initiative · NLUniversity of Oxford · GBUniversity of Cape Town · ZA

Funding

Host determinants of protection against tuberculosis in adolescentsR01AI087915 · NIAID · UNIVERSITY OF CAPE TOWN · PI SCRIBA, THOMAS JENS · 2011 to 2015
$3.3M
NIAID NIH HHS N01 AI070022NIAID NIH HHS R01 AI087915NIAID NIH HHS R01AI087915Wellcome Trust 063643Wellcome Trust 080929/Z/06/ZWellcome Trust 080957Wellcome Trust 081122Wellcome Trust 090532Wellcome Trust 095540Wellcome Trust 095780
6 · The paper itself

Abstract

rationaleNovel tuberculosis (TB) vaccines should be safe and effective in populations infected with Mycobacterium tuberculosis (M.tb) and/or HIV for effective TB control.

objectiveTo determine the safety and immunogenicity of MVA85A, a novel TB vaccine, among M.tb- and/or HIV-infected persons in a setting where TB and HIV are endemic.

methodsAn open-label, phase IIa trial was conducted in 48 adults with M.tb and/or HIV infection. Safety and immunogenicity were analyzed up to 52 weeks after intradermal vaccination with 5 × 10(7) plaque-forming units of MVA85A. Specific T-cell responses were characterized by IFN-γ enzyme-linked immunospot and whole blood intracellular cytokine staining assays. MEASUREMENTS AND MAIN

resultsMVA85A was well tolerated and no vaccine-related serious adverse events were recorded. MVA85A induced robust and durable response of mostly polyfunctional CD4(+) T cells, coexpressing IFN-γ, tumor necrosis factor-α, and IL-2. Magnitudes of pre- and postvaccination T-cell responses were lower in HIV-infected, compared with HIV-uninfected, vaccinees. No significant effect of antiretroviral therapy on immunogenicity of MVA85A was observed.

conclusionsMVA85A was safe and immunogenic in persons with HIV and/or M.tb infection. These results support further evaluation of safety and efficacy of this vaccine for prevention of TB in these target populations.

Indexed as

AdolescentAdultAIDS-Related Opportunistic InfectionsCD4 Lymphocyte CountFemaleHIV InfectionsHumansImmunity, CellularMaleMiddle AgedTuberculosis, PulmonaryTuberculosis VaccinesVaccines, DNAViral LoadViral VaccinesYoung AdultMVA 85ATuberculosis VaccinesVaccines, DNAViral Vaccines

Identifiers

PMID22281831
PMCPMC3326425
OpenAlexW2165171138

What OpenQuestion holds

Textmetadata
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.