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

Sarsenbayeva, Gulbanu; Volgin, Yevgeniy; Kassenov, Markhabat; Issagulov, Timur; Bogdanov, Nikolay; Sansyzbay, Abylay; Stukova, Marina; Buzitskaya, Zhanna; Кулмагамбетов, И. Р.; Davlyatshin, Timur; Khairullin, Berik

doi:10.1080/21645515.2017.1387345

Cited by 3 publications

(4 citation statements)

References 18 publications

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“…14,15 RIBSP vaccine was also safe and immunogenic in phase II clinical trials in healthy subjects under 60 compared to the VAXIGRIP® vaccine (widely used for vaccination of the risk groups in the Republic of Kazakhstan). 16 The humoral immune response to RIBSP vaccine meets all three requirements of the European Committee for Medical Products for Human Use of the European Medicines Agency (CHMP) CPMP/ BWP/214/96 and showed similar profile with VAXIGRIP®. 17 Evaluation of the immunogenic activity of RIBSP vaccine showed that the highest seroconversion rate for А/ H1N1pdm09 component reached 87.0% 21 days after vaccination, i.e.…”

Section: Introductionmentioning

confidence: 79%

“…The seroconversion rates for А/ H3N2 and B also exceeded the same rates of VAXIGRIP®. 16 The obtained results demonstrated that RIBSP vaccine provided seroconversion rates for all influenza vaccine components significantly exceeding CPMP/EWP/214/96 criteria for adults.…”

Section: Introductionmentioning

confidence: 85%

“…VAXIGRIP® vaccine showed insignificantly higher seroprotection rates compared to the RIBSP vaccine. 16 There were shown no significant differences in the immunogenic activity of RIBSP and VAXIGRIP® vaccines.…”

Section: Introductionmentioning

confidence: 91%

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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

Sarsenbayeva¹,

Issagulov²,

Kassenov³

et al. 2020

Human Vaccines & Immunotherapeutics

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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 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 days. The trial was registered at ClinicalTrials.gov identifier NCT 03016143.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.

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Section: Introductionmentioning

confidence: 79%

Section: Introductionmentioning

confidence: 85%

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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

Sarsenbayeva¹,

Issagulov²,

Kassenov³

et al. 2020

Human Vaccines & Immunotherapeutics

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“…12 Sesay et al reported results from a randomized multicenter phase III trial assessing the lot-to-lot consistency of the 2014-5 Northern Hemisphere quadrivalent split-virion inactivated influenza vaccine, showing that its immunogenicity was superior for the added B strain and safety was similar with that of trivalent inactivated influenza vaccine in younger and older adults. 13 Moreover, Sarsenvayeva et al showed that RIBSP 88 and VAXIGRIP have similar immunogenic and safety profiles, 14 whereas Long et al reported that the wild-type A/Solomon Islands/3/2006 (H1N1) (SI/06wt) could be used for large-scale vaccine production with sufficient safety and efficacy, as confirmed by animal experiments with mice and ferrets. 15…”

Section: Vaccinesmentioning

confidence: 99%

100 years since the 1918 influenza pandemic

Esposito

2018

Human Vaccines & Immunotherapeutics

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Nano-vaccination Strategies: Applications and Challenges for Intranasal Immunization

Pandya

Joshi

Pathak

et al. 2023

CPB

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Nasal route, a subgroup of mucosal delivery systems, constitutes a lucrative and encouraging substitute for the administration of drugs and vaccines. Over the years, a lot of research has been done in this area and scientists have successfully explored this pathway using novel formulations to combat several infections. This review article aims to address the pathways of mucosal immunization, dominance of the nasal route over other mucosal routes for immunization, and mechanism of generation of immunogenic response via nasal route and nanotechnology based approaches for intranasal vaccination. The immunotherapeutic and vaccinations for intranasal administration, available in the market are also discussed along with a brief overview of the products in the pipeline. It can also be assumed that such an approach can prove to be favorable in the designing of vaccinations for the current uncertain times. In spite of some dubious views on this.

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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

Abstract: 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.

Cited by 3 publications

References 18 publications

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

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

100 years since the 1918 influenza pandemic

Nano-vaccination Strategies: Applications and Challenges for Intranasal Immunization

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