Trial reportBMC infectious diseases2017
Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial.
Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 1 of them a synthesis 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 Randomised, Double-blind, Placebo-controlled, Single-centre Phase IIb Trial as Part of the EU-funded UNISEC Project to Assess the Immunogenicity and Safety of Different Formulations and Dosing Regimens of FLU-v Vaccine in Healthy Adults
Phase IIb Study of the Efficacy of FLU-v, a Broad Spectrum Influenza Vaccine in an H1N1 Influenza Healthy Human Challenge Model
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- A Decade in Review: A Systematic Review of Universal Influenza Vaccines in Clinical Trials during the 2010 Decade.Viruses · 2020Pooled it
- Advances in the Development of a Universal Influenza Vaccine.Antibodies (Basel, Switzerland) · 2026Review
- FLU-v, a Broad-Spectrum Peptide-Based Influenza Vaccine, Induces NK Cell Activating IgG1 and IgG3 Subclass Antibodies in Humans.Vaccines · 2025Article
- The Altered Neonatal CD8Viruses · 2024Article
- Review
- Multiantigen pan-sarbecovirus DNA vaccines generate protective T cell immune responses.JCI insight · 2023Article
- Broad-spectrum pan-genus and pan-family virus vaccines.Cell host & microbe · 2023Review
- Controlled Human Infection Models To Accelerate Vaccine Development.Clinical microbiology reviews · 2022Review
- Article
- The role of cell-mediated immunity against influenza and its implications for vaccine evaluation.Frontiers in immunology · 2022Review
- In silico design of a multi-epitope peptide construct as a potential vaccine candidate for Influenza A based on neuraminidase protein.In silico pharmacology · 2021Article
- Review
- Incomplete Freund's adjuvant reduces arginase and enhances Th1 dominance, TLR signaling and CD40 ligand expression in the vaccine site microenvironment.Journal for immunotherapy of cancer · 2020Article
- Next-generation influenza vaccines: opportunities and challenges.Nature reviews. Drug discovery · 2020Review
- Multi-Epitope Peptide-Based and Vaccinia-Based Universal Influenza Vaccine Candidates Subjected to Clinical Trials.The Malaysian journal of medical sciences : MJMS · 2020Review
- Better influenza vaccines: an industry perspective.Journal of biomedical science · 2020Review
- Recent advances in influenza vaccines.F1000Research · 2020Review
- Lessons from next generation influenza vaccines for inflammatory disease therapies.International immunopharmacology · 2019Review
- Review
- Clinical Advances in Viral-Vectored Influenza Vaccines.Vaccines · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrent influenza vaccines, based on antibodies against surface antigens, are unable to provide protection against newly emerging virus strains which differ from the vaccine strains. Therefore the population has to be re-vaccinated annually. It is thus important to develop vaccines which induce protective immunity to a broad spectrum of influenza viruses. This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of four synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated immunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses.
methodsIn a single-center, randomized, double-blind and placebo-controlled phase IIb trial, 222 healthy volunteers aged 18-60 years will be randomized (2:2:1:1) to receive two injections of a suspension of 500 μg FLU-v in saline (arm 1), one dose of emulsified 500 μg FLU-v in Montanide ISA-51 and water for injection (WFI) followed by one saline dose (arm 2), two saline doses (arm 3), or one dose of Montanide ISA-51 and WFI emulsion followed by one saline dose (arm 4). All injections will be given subcutaneously. Primary endpoints are safety and FLU-v induced CMI, evaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). Secondary outcomes are measurements of antibody responses (ELISA and multiplex), whereas exploratory outcomes include clinical efficacy and additional CMI assays (ELISpot) to show cross-reactivity. DISCUSSION: Broadly protective influenza vaccines able to provide protection against multiple strains of influenza are urgently needed. FLU-v is a promising vaccine which has shown to trigger the cell-mediated immune response. The dosages and formulations tested in this current trial are also estimated to induce antibody response. Therefore, both cellular and humoral immune responses will be evaluated.
trial registrationEudraCT number 2015-001932-38 ; retrospectively registered clinicaltrials.gov NCT02962908 (November 7th 2016).
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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.