ArticleHuman vaccines & immunotherapeutics2013
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.
Article in Human vaccines & immunotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00653770 (A Phase I Study to Assess the Safety and Immunogenicity of New TB Vaccine Candidates FP85A and MVA85A, in Healthy Adults Who Have Previously Been Immunized With BCG, Using a Prime-boost Delivery Schedule), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.
What it found
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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 to Assess the Safety and Immunogenicity of New TB Vaccine Candidates FP85A and MVA85A, in Healthy Adults Who Have Previously Been Immunized With BCG, Using a Prime-boost Delivery Schedule
Who cites it
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Research Advances for Virus-vectored Tuberculosis Vaccines and Latest Findings on Tuberculosis Vaccine Development.Frontiers in immunology · 2022Pooled it
- MVA85A vaccine to enhance BCG for preventing tuberculosis.The Cochrane database of systematic reviews · 2019Pooled it
- Vaccine against tuberculosis: what's new?BMC infectious diseases · 2014Pooled it
- Safety and immunogenicity of a candidate tuberculosis vaccine MVA85A delivered by aerosol in BCG-vaccinated healthy adults: a phase 1, double-blind, randomised controlled trial.The Lancet. Infectious diseases · 2014Trial
- Different immunogens and prime-boost vaccination strategies affect the efficacy of recombinant candidate vaccines against pathogenic orthopoxviruses.Virology journal · 2024Article
- Review
- Xyloglucan based mucosal nanovaccine for immunological protection against brucellosis developed by supercritical fluid technology.International journal of pharmaceutics: X · 2020Article
- Non-Tuberculous Mycobacteria Interference with BCG-Current Controversies and Future Directions.Vaccines · 2020Review
- Identification of Mycobacterial Ribosomal Proteins as Targets for CD4Infection and immunity · 2018Article
- Identification of Mycobacterial RplJ/L10 and RpsA/S1 Proteins as Novel Targets for CD4Infection and immunity · 2017Article
- Aerosol immunisation for TB: matching route of vaccination to route of infection.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2015Review
- Article
- Determining the validity of hospital laboratory reference intervals for healthy young adults participating in early clinical trials of candidate vaccines.Human vaccines & immunotherapeutics · 2013Article
- Prime-boost strategies in mucosal immunization affect local IgA production and the type of th response.Frontiers in immunology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 3 institutions in 1 country.
Funding
Abstract
The safety and immunogenicity of a new candidate tuberculosis (TB) vaccine, FP85A was evaluated alone and in heterologous prime-boost regimes with another candidate TB vaccine, MVA85A. This was an open label, non-controlled, non-randomized Phase I clinical trial. Healthy previously BCG-vaccinated adult subjects were enrolled sequentially into three groups and vaccinated with FP85A alone, or both FP85A and MVA85A, with a four week interval between vaccinations. Passive and active data on adverse events were collected. Immunogenicity was evaluated by Enzyme Linked Immunospot (ELISpot), flow cytometry and Enzyme Linked Immunosorbent assay (ELISA). Most adverse events were mild and there were no vaccine-related serious adverse events. FP85A vaccination did not enhance antigen 85A-specific cellular immunity. When MVA85A vaccination was preceded by FP85A vaccination, cellular immune responses were lower compared with when MVA85A vaccination was the first immunisation. MVA85A vaccination, but not FP85A vaccination, induced anti-MVA IgG antibodies. Both MVA85A and FP85A vaccinations induced anti-FP9 IgG antibodies. In conclusion, FP85A vaccination was well tolerated but did not induce antigen-specific cellular immune responses. We hypothesize that FP85A induced anti-FP9 IgG antibodies with cross-reactivity for MVA85A, which may have mediated inhibition of the immune response to subsequent MVA85A. ClinicalTrials.gov identification number: NCT00653770.
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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.