Статья

Immunogenicity and safety of a novel seasonal influenza preservative-free vaccine manufactured in Kazakhstan: Results of a randomized, comparative, phase II clinical trial in adults

G. Sarsenbayeva, Y. Volgin, M. Kassenov, T. Issagulov, N. Bogdanov, A. Sansyzbay, M. Stukova, Z. Buzitskaya, I. Кulmagambetov, T. Davlyatshin, B. Khairullin,
2021

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 volunteers aged 18–60 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 μg of hemagglutinin of each influenza virus strain recommended by WHO for the Northern hemisphere in 2016–2017 flu season. The observation period lasted 21 day. The trial was registered at ClinicalTrials.gov identifier NCT 03016143. Results: Assessment of immunogenic activity of the vaccine under study showed that in 21 day the portion of participants with 4-fold seroconversions was 87.0% to A/H1N1; 63.0% to A/H3N2 and 59.0% to B virus. Antibody titer increase factor in the group of subjects that received RIBSP vaccine was 23.3 for A/H1N1; 4.4 for A/H3N2 and 4.5 for B virus. The volunteers that received RIBSP vaccine demonstrated 95% seroprotection level against A/H1N1; 84% against A/H3N2 and 80% against B virus. RIBSP vaccine met the CHMP criteria of the Committee for Medicinal Products for Human Use (CPMP/BWP/214/96). In the course of evaluating the vaccine safety no serious undesirable effects 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 of the allantoic inactivated split vaccine obtained in vaccines RIBSP and VAXIGRIP®, showed similar immunogenic activity. Both vaccines were safe for the study participants. © 2018 Research Institute for Biological Safety Problems.

Цитирование

Похожие публикации

Источник

Версии

  • 1. Version of Record от 2021-04-27

Метаданные

Об авторах
  • G. Sarsenbayeva
    Laboratory of Technology and Biopreparation Control, Research Institute for Biological Safety Problems, Gvardeysk, Kazakhstan
  • Y. Volgin
    Vector Vaccine Laboratory, Influenza Research Institute, St. Petersburg, Russian Federation
  • M. Kassenov
    Centre for Clinical Medicine and Research, Almaty, Kazakhstan
  • T. Issagulov
    Clinical Laboratory «T-Helper», Almaty, Kazakhstan
  • N. Bogdanov
  • A. Sansyzbay
  • M. Stukova
  • Z. Buzitskaya
  • I. Кulmagambetov
  • T. Davlyatshin
  • B. Khairullin
Название журнала
  • Human Vaccines and Immunotherapeutics
Том
  • 14
Выпуск
  • 3
Страницы
  • 609-614
Ключевые слова
  • hemagglutinin; influenza vaccine; inactivated vaccine; influenza vaccine; preservative; virus antibody; adult; antibody titer; Article; blood analysis; clinical assessment; controlled study; coughing; dizziness; drug safety; edema; female; fever; follow up; headache; human; immune response; immunogenicity; Influenza A virus (H1N1); Influenza A virus (H3N2); Influenza B virus; Influenza virus; injection site induration; Kazakhstan; lymphocyte; male; middle aged; phase 2 clinical trial; rhinorrhea; seasonal influenza; seroconversion; sore throat; vaccination; viral respiratory tract infection; antibody production; clinical trial; hemagglutination inhibition test; immunology; influenza; procedures; randomized controlled trial; season; vaccination; Antibodies, Viral; Antibody Formation; Female; Hemagglutination Inhibition Tests; Humans; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H3N2 Subtype; Influenza B virus; Influenza Vaccines; Influenza, Human; Kazakhstan; Male; Preservatives, Pharmaceutical; Seasons; Vaccination; Vaccines, Inactivated
Издатель
  • Taylor and Francis Inc.
Тип документа
  • journal article
Источник
  • scopus