ArticleScientific reports2019
Characterization of potential biomarkers of reactogenicity of licensed antiviral vaccines: randomized controlled clinical trials conducted by the BIOVACSAFE consortium.
Article in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis 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 Clinical Study to Generate an Exploratory Training Set of Data Characterising Clinical Events, Physiological and Metabolic Responses, and Innate and Adaptive Immune Responses Following a Single Subcutaneous Immunisation With Either "Varilrix" Varicella-zoster Vaccine, "Stamaril" Yellow Fever Vaccine or Saline Placebo in Healthy Adults With Evidence of Pre-existing Immunity to Varicella-zoster and no Existing Immunity to Yellow Fever.
Clinical Study to Generate Exploratory Training Data Characterising Clinical Events, Physiological & Metabolic Responses, & Innate & Adaptive Immune Responses Following 1st & 3rd of 3 IM Immunisations With "Engerix B" HepB Vaccine or Placebo in Healthy Adults With no Pre-existing Immunity to HepB
A Clinical Study to Generate an Exploratory Training Set of Data Characterising Clinical Events, Physiological and Metabolic Responses, and Innate and Adaptive Immune Responses Following a Single Intramuscular Immunisation With Either "Fluad" or "Agrippal" Influenza Vaccines or Saline Placebo in Healthy Adults.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- Pooled it
- An innate immune signature induced by AS01- or AS03-adjuvanted vaccines predicts the antibody response magnitude and quality consistently over time.Frontiers in immunology · 2024Trial
- Article
- The EDC mixture "NeuroMix" alters neuroendocrine physiology, fatty food preference, and the central reward transcriptome.Endocrinology · 2026Article
- De-risking vaccine development: lessons, challenges, and prospects.NPJ vaccines · 2025Review
- Markov field network model of multi-modal data predicts effects of immune system perturbations on intravenous BCG vaccination in macaques.Cell systems · 2024Article
- Markov Field network model of multi-modal data predicts effects of immune system perturbations on intravenous BCG vaccination in macaques.bioRxiv : the preprint server for biology · 2024Article
- Article
- Cynomolgus macaques as a translational model of human immune responses to yellow fever 17D vaccination.Journal of virology · 2024Article
- Q fever immunology: the quest for a safe and effective vaccine.NPJ vaccines · 2023Review
- Memory-like innate response to booster vaccination with MF-59 adjuvanted influenza vaccine in children.NPJ vaccines · 2023Article
- Post-vaccination serum cytokines levels correlate with breakthrough influenza infections.Scientific reports · 2023Article
- Innate immune suppression by SARS-CoV-2 mRNA vaccinations: The role of G-quadruplexes, exosomes, and MicroRNAs.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2022Article
- Biclustering analysis of functionals via penalized fusion.Journal of multivariate analysis · 2022Article
- Subsequent AS01-adjuvanted vaccinations induce similar transcriptional responses in populations with different disease statuses.PloS one · 2022Article
- Review
- Article
- Early detection of SARS-CoV-2 and other infections in solid organ transplant recipients and household members using wearable devices.Transplant international : official journal of the European Society for Organ Transplantation · 2021Review
- Dynamic Immune/Inflammation Precision Medicine: The Good and the Bad Inflammation in Infection and Cancer.Frontiers in immunology · 2021Review
- Transforming vaccine development.Seminars in immunology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 9 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biomarkers predictive of inflammatory events post-vaccination could accelerate vaccine development. Within the BIOVACSAFE framework, we conducted three identically designed, placebo-controlled inpatient/outpatient clinical studies (NCT01765413/NCT01771354/NCT01771367). Six antiviral vaccination strategies were evaluated to generate training data-sets of pre-/post-vaccination vital signs, blood changes and whole-blood gene transcripts, and to identify putative biomarkers of early inflammation/reactogenicity that could guide the design of subsequent focused confirmatory studies. Healthy adults (N = 123; 20-21/group) received one immunization at Day (D)0. Alum-adjuvanted hepatitis B vaccine elicited vital signs and inflammatory (CRP/innate cells) responses that were similar between primed/naive vaccinees, and low-level gene responses. MF59-adjuvanted trivalent influenza vaccine (ATIV) induced distinct physiological (temperature/heart rate/reactogenicity) response-patterns not seen with non-adjuvanted TIV or with the other vaccines. ATIV also elicited robust early (D1) activation of IFN-related genes (associated with serum IP-10 levels) and innate-cell-related genes, and changes in monocyte/neutrophil/lymphocyte counts, while TIV elicited similar but lower responses. Due to viral replication kinetics, innate gene activation by live yellow-fever or varicella-zoster virus (YFV/VZV) vaccines was more suspended, with early IFN-associated responses in naïve YFV-vaccine recipients but not in primed VZV-vaccine recipients. Inflammatory responses (physiological/serum markers, innate-signaling transcripts) are therefore a function of the vaccine type/composition and presence/absence of immune memory. The data reported here have guided the design of confirmatory Phase IV trials using ATIV to provide tools to identify inflammatory or reactogenicity biomarkers.
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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.