Trial reportVaccine2012
Randomized clinical trial of immunogenicity and safety of a recombinant H1N1/2009 pandemic influenza vaccine containing Advax™ polysaccharide adjuvant.
Trial report in Vaccine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
66 citing papers in PubMed, 112 citations in OpenAlex.
- Trial
- A Multiseason Randomized Controlled Trial of Advax-Adjuvanted Seasonal Influenza Vaccine in Participants With Chronic Disease or Older Age.The Journal of infectious diseases · 2024Trial
- Ability of SpikoGen®, an Advax-CpG adjuvanted recombinant spike protein vaccine, to induce cross-neutralising antibodies against SARS-CoV-2 variants.Immunology · 2023Trial
- Safety and immunogenicity of SpikoGen®, an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022Trial
- Efficacy of influenza vaccine (Fluvax) in cancer patients on treatment: a prospective single arm, open-label study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Trial
- Randomized controlled trial demonstrating the benefits of delta inulin adjuvanted immunotherapy in patients with bee venom allergy.The Journal of allergy and clinical immunology · 2019Trial
- Induction of Human T-cell and Cytokine Responses Following Vaccination with a Novel Influenza Vaccine.Scientific reports · 2018Trial
- Panblok-H1+advax H1N1/2009pdm vaccine: Insights into rapid development of a delta inulin adjuvanted recombinant pandemic influenza vaccine.Human vaccines & immunotherapeutics · 2017Trial
- Systemic and mucosal immune responses following oral adenoviral delivery of influenza vaccine to the human intestine by radio controlled capsule.Scientific reports · 2016Trial
- Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant.Vaccine · 2016Trial
- Trial
- Trial
- Human anthrax vaccines: Current status and future prospects.Human vaccines & immunotherapeutics · 2025Review
- Article
- Engineered polysaccharides for controlling innate and adaptive immune responses.Nature reviews bioengineering · 2024Article
- Inulin-based formulations as an emerging therapeutic strategy for cancer: A comprehensive review.International journal of biological macromolecules · 2024Review
- Colorectal cancer and inulin supplementation: the good, the bad, and the unhelpful.Gastroenterology report · 2024Review
- Article
- Plant-derived immuno-adjuvants in vaccines formulation: a promising avenue for improving vaccines efficacy against SARS-CoV-2 virus.Pharmacological reports : PR · 2022Review
- Influenza vaccines: Past, present, and future.Reviews in medical virology · 2022Review
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundTimely vaccine supply is critical during influenza pandemics. A recombinant hemagglutinin (rHA)-based vaccine could overcome production hurdles of egg-based vaccines but has never previously been tested in a real-life pandemic setting. The primary aim was to determine the efficacy of a recombinant pandemic vaccine and whether its immunogenicity could be enhanced by a novel polysaccharide adjuvant (Advax™).
methods281 adults aged 18-70 years were recruited in a randomized, subject and observer blinded, parallel-group study of rHA H1N1/2009 vaccine with or without adjuvant. Immunizations were at 0 and 3 weeks with rHA 3, 11 or 45 μg. Serology and safety was followed for 6 months.
resultsAt baseline, only 9.1% of subjects (95% CI: 6.0-13.2) had seroprotective H1N1/2009 titers. Seroconversion rates varied by rHA dose, presence of adjuvant, subject age and number of immunizations. Eighty percent (95% CI: 52-96) of 18-49 year olds who received rHA 45 μg with adjuvant were seroprotected at week 3, representing a 11.1-fold increase in antibody titers from baseline. Advax™ adjuvant increased seroprotection rates by 1.9 times after the first, and 2.5 times after the second, immunization when compared to rHA alone. Seroprotection was sustained at 26 weeks and the vaccine was well tolerated with no safety issues.
conclusionsThe study confirmed the ability to design, manufacture, and release a recombinant vaccine within a short time from the start of an actual influenza pandemic. Advax™ adjuvant significantly enhanced rHA immunogenicity.
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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.