Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan

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Hum Vaccin Immunother. 2020 Feb 12:1-7. doi: 10.1080/21645515.2019.1705691. [Epub ahead of print] Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan.

Sarsenbayeva G¹, Issagulov T¹, Kassenov M¹, Abitay R¹, Orynbayev M¹, Stukova M², Pisareva M², Davlyatshin T³, Lespek K¹, Khairullin B¹.
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Abstract

Background: The study was aimed at comparative evaluation of seasonal influenza vaccine RIBSP versus commercial vaccine VAXIGRIP? for immunogenicity and safety in the course of clinical trial phase II on healthy subjects up to 60 years.Methods: The trial involved 150 subjects in randomized 2:1 groups that received either RIBSP vaccine or comparator vaccine VAXIGRIP?. One dose (0.5 ml) of either vaccine contained 15 ?g of hemagglutinin of each influenza virus strain recommended by WHO for the Northern hemisphere in 2016-2017 flu season. The observation period lasted 21 days. The trial was registered at ClinicalTrials.gov identifier NCT03016143.Results: Assessment of immunogenic activity of the vaccine under study showed that in 21 days the portion of participants with 4-fold seroconversions was 80.0% to А/H1N1; 65.0% to А/H3N2 and 64.0% to B virus. Antibody titer increase factor in the group of subjects that received RIBSP vaccine was 13.4 for А/H1N1; 5.2 for А/H3N2 and 5.2 for B virus. The subjects that received RIBSP vaccine demonstrated 88% seroprotection rate against А/H1N1; 75% against А/H3N2 and 61% against B virus. In the course of evaluating the vaccine safety, no serious adverse events were recorded. All changes of laboratory data were slight and single in most cases. All recorded local reactions have been light in character and these have been predicted reactions observed at vaccination against influenza.Conclusion: Comparison vaccines RIBSP and VAXIGRIP?, showed similar immunogenic activity. The RIBSP vaccine is safe and immunogenic for the elderly and conforms to international criteria in CPMP/BWP/214/96.


KEYWORDS:

Humoral immunity; Influenza virus; Vaccines/vaccines strains

PMID: 32048890 DOI: 10.1080/21645515.2019.1705691