Trial reportPloS one2007
Boosting BCG with recombinant modified vaccinia ankara expressing antigen 85A: different boosting intervals and implications for efficacy trials.
Trial report in PloS one, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 35 papers, 2 of them syntheses that pooled 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.
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.
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Received BCG Immunisation 1 Month Previously
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Previously Received BCG
A Study of the Immunogenicity of M. Bovis BCG (SSI Strain), Delivered Intradermally in Healthy Volunteers
Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The Systematic Review and Meta-Analysis on the Immunogenicity and Safety of the Tuberculosis Subunit Vaccines M72/AS01Frontiers in immunology · 2020Pooled it
- MVA85A vaccine to enhance BCG for preventing tuberculosis.The Cochrane database of systematic reviews · 2019Pooled it
- A novel nanoparticle vaccine displaying multistage tuberculosis antigens confers protection in mice infected with H37Rv.NPJ vaccines · 2025Article
- Article
- Exploring the Potential Role of Moonlighting Function of the Surface-Associated Proteins FromFrontiers in immunology · 2019Article
- Boosting BCG-primed responses with a subunit Apa vaccine during the waning phase improves immunity and imparts protection against Mycobacterium tuberculosis.Scientific reports · 2016Article
- Protective capacity of proteoliposomes from Mycobacterium bovis BCG in a mouse model of tuberculosis.Human vaccines & immunotherapeutics · 2015Article
- The three Mycobacterium tuberculosis antigen 85 isoforms have unique substrates and activities determined by non-active site regions.The Journal of biological chemistry · 2014Article
- Host immune responses to mycobacterial antigens and their implications for the development of a vaccine to control tuberculosis.Clinical and experimental vaccine research · 2014Review
- Novel GMO-Based Vaccines against Tuberculosis: State of the Art and Biosafety Considerations.Vaccines · 2014Review
- Comparison of BCG prime-DNA booster and rBCG regimens for protection against tuberculosis.Human vaccines & immunotherapeutics · 2014Article
- Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines.Human vaccines & immunotherapeutics · 2013Article
- Safety and immunogenicity of an FP9-vectored candidate tuberculosis vaccine (FP85A), alone and with candidate vaccine MVA85A in BCG-vaccinated healthy adults: a phase I clinical trial.Human vaccines & immunotherapeutics · 2013Article
- Article
- Deletion of specific immune-modulatory genes from modified vaccinia virus Ankara-based HIV vaccines engenders improved immunogenicity in rhesus macaques.Journal of virology · 2012Article
- Effect of vaccine dose on the safety and immunogenicity of a candidate TB vaccine, MVA85A, in BCG vaccinated UK adults.Vaccine · 2012Article
- Article
- Impact of toll-like receptor 2 deficiency on immune responses to mycobacterial antigens.Infection and immunity · 2011Article
- Tuberculosis vaccines: beyond bacille Calmette-Guerin.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2011Review
- Tuberculosis vaccines in clinical trials.Expert review of vaccines · 2011Review
Corrections and comments
- Erratum issued
Authors and funding
9 authors.
Funding
Abstract
objectivesTo investigate the safety and immunogenicity of boosting BCG with modified vaccinia Ankara expressing antigen 85A (MVA85A), shortly after BCG vaccination, and to compare this first with the immunogenicity of BCG vaccination alone and second with a previous clinical trial where MVA85A was administered more than 10 years after BCG vaccination.
designThere are two clinical trials reported here: a Phase I observational trial with MVA85A; and a Phase IV observational trial with BCG. These clinical trials were all conducted in the UK in healthy, HIV negative, BCG naïve adults. Subjects were vaccinated with BCG alone; or BCG and then subsequently boosted with MVA85A four weeks later (short interval). The outcome measures, safety and immunogenicity, were monitored for six months. The immunogenicity results from this short interval BCG prime-MVA85A boost trial were compared first with the BCG alone trial and second with a previous clinical trial where MVA85A vaccination was administered many years after vaccination with BCG.
resultsMVA85A was safe and highly immunogenic when administered to subjects who had recently received BCG vaccination. When the short interval trial data presented here were compared with the previous long interval trial data, there were no significant differences in the magnitude of immune responses generated when MVA85A was administered shortly after, or many years after BCG vaccination.
conclusionsThe clinical trial data presented here provides further evidence of the ability of MVA85A to boost BCG primed immune responses. This boosting potential is not influenced by the time interval between prior BCG vaccination and boosting with MVA85A. These findings have important implications for the design of efficacy trials with MVA85A. Boosting BCG induced anti-mycobacterial immunity in either infancy or adolescence are both potential applications for this vaccine, given the immunological data presented here.
trial registrationClinicalTrials.gov NCT00427453 (short boosting interval), NCT00427830 (long boosting interval), NCT00480714 (BCG alone).
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Identifiers
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.