Trial reportBritish journal of clinical pharmacology2017
Dose sparing and the lack of a dose-response relationship with an influenza vaccine in adult and elderly patients - a randomized, double-blind clinical trial.
Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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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
8 citing papers in PubMed.
- Trial
- Dose sparing and the lack of a dose-response relationship with an influenza vaccine in adult and elderly patients - a randomized, double-blind clinical trial.British journal of clinical pharmacology · 2017Trial
- From Sharks to Yeasts: Squalene in the Development of Vaccine Adjuvants.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Effectiveness of the Adjuvanted Influenza Vaccine in Older Adults at High Risk of Influenza Complications.Vaccines · 2021Article
- Next-Generation Influenza HA Immunogens and Adjuvants in Pursuit of a Broadly Protective Vaccine.Viruses · 2021Review
- [Composition and mode of action of adjuvants in licensed viral vaccines].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2019Review
- Recalling the Future: Immunological Memory Toward Unpredictable Influenza Viruses.Frontiers in immunology · 2019Review
- Adjuvanted influenza vaccines.Human vaccines & immunotherapeutics · 2018Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe currently licensed seasonal trivalent influenza vaccines contain 15 μg haemagglutinin per strain for adult, and up to 60 μg for elderly patients. However, due to recent shortages, dose sparing to increase production capacity would be highly desirable. In the present study, we attempted to find a dose-response relationship for immunogenicity and, thus, the optimal dose for seasonal influenza vaccines in adult and elderly patients.
methodsA total of 256 subjects, including adult (aged 18-60 years) and elderly (aged over 60 years) individuals, were enrolled. Subjects were randomly assigned in a 1:1:1:1 ratio to receive a whole-virion, aluminium-adjuvanted trivalent influenza vaccine containing 3.5, 6, 9 or 15 μg haemagglutinin of seasonal A/H1N1, A/H3N2 and B influenza antigens manufactured by Omninvest Ltd., Hungary. Serum antibody titres against the vaccine virus strains were measured by haemagglutination inhibition.
resultAll vaccines were well tolerated. All four vaccines fulfilled all three immunogenicity licensing criteria, as determined by the European Committee for Proprietary Medicinal Products (CPMP)/Biotechnology Working Party (BWP)/214/96 guideline for all three virus strains and both age groups. The 3.5 μg vaccine showed 28% less seroconversion compared to the 15 μg dose in terms of influenza AH3N2 in the adult group (95% confidence interval -51, -3; P < 0.05). All other doses showed no significant difference in immunogenicity compared with the licensed vaccine containing 15 μg haemagglutinin.
conclusionsOur data suggested that significant dose sparing is possible with the use of whole-virion vaccines and aluminium adjuvants, without compromising safety. This could have significant economic and public health impacts.
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