Trial reportPloS one2017
Cell-Based Systems Biology Analysis of Human AS03-Adjuvanted H5N1 Avian Influenza Vaccine Responses: A Phase I Randomized Controlled Trial.
Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01573312 (A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered With and Without AS03 Adjuvant), which is not on this map. Cited by 47 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.
A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered With and Without AS03 Adjuvant: Standard & Systems Biology Analyses
Who cites it
47 citing papers in PubMed, 63 citations in OpenAlex.
- Transcriptomic and proteomic signatures following AS03-adjuvanted Influenza A/H7N9 vaccine.Frontiers in immunology · 2026Trial
- Metabolomic Signatures Differentiate Immune Responses in Avian Influenza Vaccine Recipients.The Journal of infectious diseases · 2024Trial
- AS03-Adjuvanted H5N1 Avian Influenza Vaccine Modulates Early Innate Immune Signatures in Human Peripheral Blood Mononuclear Cells.The Journal of infectious diseases · 2019Trial
- Article
- Decoding disease and therapy through multiomics integration and systems analysis.Briefings in bioinformatics · 2026Review
- Systems-Level Analysis of HPAI H5N1 Infection in Ducks: Integrating Transcriptomic, Proteomic, and Phosphoproteomic Data.International journal of molecular sciences · 2026Article
- Adaptive immune responses to vaccination reflect social status at first exposure in female rhesus macaques.bioRxiv : the preprint server for biology · 2026Article
- The Role and Safety of Aluminum Adjuvants in Childhood Vaccines.Pediatrics · 2026Review
- Elicitation of protective immune responses against influenza a viruses in elderly ferrets by adjuvanted recombinant universal influenza hemagglutinin vaccines.Immunity & ageing : I & A · 2025Article
- Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- Modular assembly and immunological evaluation of a promising bioconjugate nanovaccine against Klebsiella pneumoniae O2 serotype.NPJ vaccines · 2025Article
- Assessment ofMolecular pharmaceutics · 2025Article
- Linking vaccine adjuvant mechanisms of action to function.Science immunology · 2025Review
- Chronic inflammation degrades CD4 T cell immunity to prior vaccines in treated HIV infection.Nature communications · 2024Article
- Acute and persistent responses after H5N1 vaccination in humans.Cell reports · 2024Article
- Article
- Memory-like innate response to booster vaccination with MF-59 adjuvanted influenza vaccine in children.NPJ vaccines · 2023Article
- Mind the Gap-A Perspective on Strategies for Protecting against Bacterial Infections during the Period from Infection to Eradication.Microorganisms · 2023Review
- Multiscale integration of human and single-cell variations reveals unadjuvanted vaccine high responders are naturally adjuvanted.medRxiv : the preprint server for health sciences · 2023Article
- Systems serology-based comparison of antibody effector functions induced by adjuvanted vaccines to guide vaccine design.NPJ vaccines · 2023Article
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 3 institutions in 1 country.
Funding
Abstract
backgroundVaccine development for influenza A/H5N1 is an important public health priority, but H5N1 vaccines are less immunogenic than seasonal influenza vaccines. Adjuvant System 03 (AS03) markedly enhances immune responses to H5N1 vaccine antigens, but the underlying molecular mechanisms are incompletely understood. OBJECTIVE AND
methodsWe compared the safety (primary endpoint), immunogenicity (secondary), gene expression (tertiary) and cytokine responses (exploratory) between AS03-adjuvanted and unadjuvanted inactivated split-virus H5N1 influenza vaccines. In a double-blinded clinical trial, we randomized twenty adults aged 18-49 to receive two doses of either AS03-adjuvanted (n = 10) or unadjuvanted (n = 10) H5N1 vaccine 28 days apart. We used a systems biology approach to characterize and correlate changes in serum cytokines, antibody titers, and gene expression levels in six immune cell types at 1, 3, 7, and 28 days after the first vaccination.
resultsBoth vaccines were well-tolerated. Nine of 10 subjects in the adjuvanted group and 0/10 in the unadjuvanted group exhibited seroprotection (hemagglutination inhibition antibody titer > 1:40) at day 56. Within 24 hours of AS03-adjuvanted vaccination, increased serum levels of IL-6 and IP-10 were noted. Interferon signaling and antigen processing and presentation-related gene responses were induced in dendritic cells, monocytes, and neutrophils. Upregulation of MHC class II antigen presentation-related genes was seen in neutrophils. Three days after AS03-adjuvanted vaccine, upregulation of genes involved in cell cycle and division was detected in NK cells and correlated with serum levels of IP-10. Early upregulation of interferon signaling-related genes was also found to predict seroprotection 56 days after first vaccination.
conclusionsUsing this cell-based systems approach, novel mechanisms of action for AS03-adjuvanted pandemic influenza vaccination were observed.
trial registrationClinicalTrials.gov NCT01573312.
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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 Socratic graph.