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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.
Hum Vaccin Immunother. 2018 03 04; 14(3):609-614.HV

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 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.

Authors+Show Affiliations

a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.b Vector Vaccine Laboratory , Influenza Research Institute , St. Petersburg , Russian Federation.b Vector Vaccine Laboratory , Influenza Research Institute , St. Petersburg , Russian Federation.c Centre for Clinical Medicine and Research , Almaty , Kazakhstan.d Clinical Laboratory «T-Helper» , Almaty , Kazakhstan.a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29112488

Citation

Sarsenbayeva, Gulbanu, et al. "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." Human Vaccines & Immunotherapeutics, vol. 14, no. 3, 2018, pp. 609-614.
Sarsenbayeva G, Volgin Y, Kassenov M, et al. 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. Hum Vaccin Immunother. 2018;14(3):609-614.
Sarsenbayeva, G., Volgin, Y., Kassenov, M., Issagulov, T., Bogdanov, N., Sansyzbay, A., Stukova, M., Buzitskaya, Z., Кulmagambetov, I., Davlyatshin, T., & Khairullin, B. (2018). 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. Human Vaccines & Immunotherapeutics, 14(3), 609-614. https://doi.org/10.1080/21645515.2017.1387345
Sarsenbayeva G, et al. 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. Hum Vaccin Immunother. 2018 03 4;14(3):609-614. PubMed PMID: 29112488.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Sarsenbayeva,Gulbanu, AU - Volgin,Yevgeniy, AU - Kassenov,Markhabat, AU - Issagulov,Timur, AU - Bogdanov,Nikolay, AU - Sansyzbay,Abylay, AU - Stukova,Marina, AU - Buzitskaya,Zhanna, AU - Кulmagambetov,Ilyas, AU - Davlyatshin,Timur, AU - Khairullin,Berik, Y1 - 2017/12/12/ PY - 2017/11/8/pubmed PY - 2019/1/3/medline PY - 2017/11/8/entrez KW - immune responses KW - influenza KW - phase II trial KW - safety KW - seasonal KW - vaccine SP - 609 EP - 614 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 14 IS - 3 N2 - 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/29112488/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_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1387345 DB - PRIME DP - Unbound Medicine ER -