Trial reportViruses2012
Safety and immunogenicity of a plant-produced recombinant hemagglutinin-based influenza vaccine (HAI-05) derived from A/Indonesia/05/2005 (H5N1) influenza virus: a phase 1 randomized, double-blind, placebo-controlled, dose-escalation study in healthy adults.
Trial report in Viruses, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 5 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed, 5 syntheses or guidelines pooled it, 76 citations in OpenAlex.
- Tobacco-Based Vaccines, Hopes, and Concerns: A Systematic Review.Molecular biotechnology · 2023Pooled it
- Pooled it
- A Decade in Review: A Systematic Review of Universal Influenza Vaccines in Clinical Trials during the 2010 Decade.Viruses · 2020Pooled it
- Aluminum salts as an adjuvant for pre-pandemic influenza vaccines: a meta-analysis.Scientific reports · 2018Pooled it
- Vaccines for preventing influenza in healthy adults.The Cochrane database of systematic reviews · 2018Pooled it
- An intranasal adjuvanted, recombinant influenza A/H5 vaccine primes against diverse H5N1 clades: a phase I trial.Nature communications · 2025Trial
- Rickettsial Diseases and Vaccines: Is There an Opportunity for Plant-Made Vaccine Technology?Biotechnology and bioengineering · 2026Review
- Prokaryote- and Eukaryote-Based Expression Systems: Advances in Post-Pandemic Viral Antigen Production for Vaccines.International journal of molecular sciences · 2024Review
- Exploring recent progress of molecular farming for therapeutic and recombinant molecules in plant systems.Heliyon · 2024Review
- Review
- Facilitating viral vector movement enhances heterologous protein production in an established plant system.Plant biotechnology journal · 2023Article
- Accumulation of colicin M protein and its biological activity in transgenic lettuce and mizuna plants.Frontiers in plant science · 2023Article
- Review
- Emerging prospects of protein/peptide-based nanoassemblies for drug delivery and vaccine development.Nano research · 2022Article
- Engineering of Plants for Efficient Production of Therapeutics.Molecular biotechnology · 2021Review
- Contributions of the international plant science community to the fight against human infectious diseases - part 1: epidemic and pandemic diseases.Plant biotechnology journal · 2021Review
- Plant-Based COVID-19 Vaccines: Current Status, Design, and Development Strategies of Candidate Vaccines.Vaccines · 2021Review
- Frontiers in the Standardization of the Plant Platform for High Scale Production of Vaccines.Plants (Basel, Switzerland) · 2021Review
- Producing Vaccines against Enveloped Viruses in Plants: Making the Impossible, Difficult.Vaccines · 2021Review
- Plant Platforms for Efficient Heterologous Protein Production.Biotechnology and bioprocess engineering : BBE · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recently, we have reported [1,2] on a subunit influenza vaccine candidate based on the recombinant hemagglutinin protein from the A/Indonesia/05/2005 (H5N1) strain of influenza virus, produced it using 'launch vector'-based transient expression technology in Nicotiana benthamiana, and demonstrated its immunogenicity in pre-clinical studies. Here, we present the results of a first-in-human, Phase 1 randomized, double-blind, placebo-controlled study designed to investigate safety, reactogenicity and immunogenicity of three escalating dose levels of this vaccine, HAI-05, (15, 45 and 90 µg) adjuvanted with Alhydrogel® (0.75 mg aluminum per dose) and the 90 µg dose level without Alhydrogel®. Vaccine was administered intramuscularly in two injections three weeks apart to healthy adults of 18-49 years of age. At all dose levels the vaccine was generally safe and well tolerated, with no reported serious adverse events or dose-limiting toxicities. Mild local and systemic reactions were observed in all vaccine dose groups and the placebo group and their occurrence was not dose related. The incidence rates were higher in the groups receiving vaccine with Alhydrogel®. The immune response elicited by the HAI-05 vaccine was variable with respect to both hemagglutination-inhibition and virus microneutralization antibody titers, with the highest responses observed in the 90 µg unadjuvanted group.
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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.