Trial reportTuberculosis (Edinburgh, Scotland)2013
Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG.
Trial report in Tuberculosis (Edinburgh, Scotland), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00953927 (Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants), which is not on this map. Cited by 27 papers.
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.
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.
Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants
Who cites it
27 citing papers in PubMed, 47 citations in OpenAlex.
- Trial
- Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomised, placebo-controlled phase 2b trial.Lancet (London, England) · 2013Trial
- Soluble immune mediators orchestrate protectiveeLife · 2025Article
- The TB vaccine clinical trial centre directory: An inventory of clinical trial centres in Sub-Saharan Africa.PloS one · 2024Article
- Impaired macrophage and memory T-cell responses to Bacillus Calmette-Guerin nonpolar lipid extract.Frontiers in immunology · 2023Article
- COVID-19 preparedness: capacity to manufacture vaccines, therapeutics and diagnostics in sub-Saharan Africa.Globalization and health · 2021Review
- The TB vaccine development pathway - An innovative approach to accelerating global TB vaccine development.Tuberculosis (Edinburgh, Scotland) · 2021Article
- Recent Advances in the Development of Protein- and Peptide-Based Subunit Vaccines against Tuberculosis.Cells · 2020Review
- Tuberculosis susceptibility and protection in children.The Lancet. Infectious diseases · 2019Review
- An Auto-luminescent Fluorescent BCG Whole Blood Assay to Enable Evaluation of Paediatric Mycobacterial Responses Using Minimal Blood Volumes.Frontiers in pediatrics · 2019Article
- Age-related waning of immune responses to BCG in healthy children supports the need for a booster dose of BCG in TB endemic countries.Scientific reports · 2018Article
- Progress and challenges in TB vaccine development.F1000Research · 2018Review
- Lessons from the first clinical trial of a non-licensed vaccine among Ugandan adolescents: a phase II field trial of the tuberculosis candidate vaccine, MVA85A.Wellcome open research · 2018Article
- Trying to See the Forest through the Trees: Deciphering the Nature of Memory Immunity toFrontiers in immunology · 2018Review
- Reasons for optimism in the search for new vaccines for tuberculosis.Epidemiology and infection · 2017Article
- Enhancement of Antituberculosis Immunity in a Humanized Model System by a Novel Virus-Vectored Respiratory Mucosal Vaccine.The Journal of infectious diseases · 2017Article
- A novel therapeutic strategy of lipidated promiscuous peptide against Mycobacterium tuberculosis by eliciting Th1 and Th17 immunity of host.Scientific reports · 2016Article
- Computational and Empirical Studies Predict Mycobacterium tuberculosis-Specific T Cells as a Biomarker for Infection Outcome.PLoS computational biology · 2016Article
- Drug-resistant TB: deadly, costly and in need of a vaccine.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2016Review
- Immunology studies in non-human primate models of tuberculosis.Immunological reviews · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundNew tuberculosis (TB) vaccines are being developed to combat the global epidemic. A phase IIb trial of a candidate vaccine, MVA85A, was conducted in a high burden setting in South Africa to evaluate proof-of-concept efficacy for prevention of TB in infants.
objectiveTo describe the study design and implementation lessons from an infant TB vaccine efficacy trial.
methodsThis was a randomised, controlled, double-blind clinical trial comparing the safety and efficacy of MVA85A to Candin control administered to 4-6-month-old, BCG-vaccinated, HIV-negative infants at a rural site in South Africa. Infants were followed up for 15-39 months for incident TB disease based on pre-specified endpoints.
results2797 infants were enrolled over 22 months. Factors adversely affecting recruitment and the solutions that were implemented are discussed. Slow case accrual led to six months extension of trial follow up.
conclusionThe clinical, regulatory and research environment for modern efficacy trials of new TB vaccines are substantially different to that when BCG vaccine was first evaluated in infants. Future infant TB vaccine trials will need to allocate sufficient resources and optimise operational efficiency. A stringent TB case definition is necessary to maximize specificity, and TB case accrual must be monitored closely.
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What OpenQuestion holds
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.