Trial reportThe Lancet. Infectious diseases2016
H7N9 live attenuated influenza vaccine in healthy adults: a randomised, double-blind, placebo-controlled, phase 1 trial.
Trial report in The Lancet. Infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02480101 (Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Anhui/2013/61), which is not on this map. Cited by 28 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.
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Anhui/2013/61 (H7N9) Influenza Vaccine
Who cites it
28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Virus-induced pathogenesis, vaccine development, and diagnosis of novel H7N9 avian influenza A virus in humans: a systemic literature review.The Journal of international medical research · 2020Pooled it
- Comparative effectiveness of H7N9 vaccines in healthy individuals.Human vaccines & immunotherapeutics · 2019Pooled it
- Trial
- Article
- Review
- Pandemic preparedness through vaccine development for avian influenza viruses.Human vaccines & immunotherapeutics · 2024Review
- In Vitro Stimulation with Live SARS-CoV-2 Suggests Th17 Dominance In Virus-Specific CD4+ T Cell Response after COVID-19.Vaccines · 2022Article
- Antigenic Characterization of Neuraminidase of Influenza A/H7N9 Viruses Isolated in Different Years.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Development of a T Cell-Based COVID-19 Vaccine Using a Live Attenuated Influenza Vaccine Viral Vector.Vaccines · 2022Article
- Designing a multi-epitope vaccine to provoke the robust immune response against influenza A H7N9.Scientific reports · 2021Article
- Safety and Efficacy of Spray Intranasal Live Attenuated Influenza Vaccine: Systematic Review and Meta-Analysis.Vaccines · 2021Review
- Detection of IFNγ-Secreting CD4Viruses · 2021Article
- A Strategy to Elicit M2e-Specific Antibodies Using a Recombinant H7N9 Live Attenuated Influenza Vaccine Expressing Multiple M2e Tandem Repeats.Biomedicines · 2021Article
- Computational design of SARS-CoV-2 spike glycoproteins to increase immunogenicity by T cell epitope engineering.Computational and structural biotechnology journal · 2021Article
- Development and Evaluation of Vero Cell-Derived Master Donor Viruses for Influenza Pandemic Preparedness.Vaccines · 2020Article
- Rational Design of SARS-CoV-2 Spike Glycoproteins To Increase Immunogenicity By T Cell Epitope Engineering.bioRxiv : the preprint server for biology · 2020Article
- Article
- Study of Neuraminidase-Inhibiting Antibodies in Clinical Trials of Live Influenza Vaccines.Antibodies (Basel, Switzerland) · 2020Article
- Research progress on human infection with avian influenza H7N9.Frontiers of medicine · 2020Review
- H7N9 influenza split vaccine with SWE oil-in-water adjuvant greatly enhances cross-reactive humoral immunity and protection against severe pneumonia in ferrets.NPJ vaccines · 2020Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundH7N9 avian influenza viruses characterised by high virulence and presence of mammalian adaptation markers have pandemic potential. Specific influenza vaccines remain the main defence. We assessed the safety and immunogenicity of an H7N9 live attenuated influenza vaccine (LAIV) candidate in healthy adult volunteers.
methodsWe did a phase 1, double-blind, randomised, placebo-controlled trial in Saint Petersburg, Russia. Eligible participants were healthy adults aged 18-49 years. The participants were randomised 3:1 to receive live vaccine or placebo, according to a computer-generated randomisation scheme. Two doses of vaccine or placebo were administered intranasally 28 days apart, each followed by 7 day stays in hospital. Immune responses were assessed in nasal swabs, saliva, and serum specimens collected before and 28 days after each vaccine dose. The primary outcome was the safety profile. This trial is registered with ClinicalTrials.gov, number NCT02480101.
findingsBetween Oct 21, 2014, and Oct 31, 2014, 40 adults were randomised, of whom 39 (98%) were included in the per-protocol analysis (29 in the vaccine group and ten in the placebo group). The frequency of adverse events did not differ between the vaccine and placebo groups. Seroconversion of neutralising antibodies was seen in 14 participants after the first vaccine dose (48%, 95% CI 29·4-67·5) and 21 after the second vaccine dose (72%, 52·8-87·3). Immune responses were seen in 27 of 29 recipients (93%, 95% CI 77·2-99·2). Adverse effects were seen in 19 (63%) vaccine recipients and nine (90%) placebo recipients after the first dose and in nine (31%) and four (40%), respectively, after the second dose. These effects were mainly local and all were mild.
interpretationThe H7N9 LAIV was well tolerated and safe and showed good immunogenicity.
fundingWHO.
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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.