Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infection
Scientific relevance. Intranasal vaccination may dramatically change current approaches to mass immunisation against various infections, shifting the focus from inducing systemic humoral and cellular immune responses to developing mucosal immunity and protective barriers on the mucous membranes, whi...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2023-10-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/494 |
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| author | E. V. Zuev O. L. Evdokimova O. A. Markova I. A. Korotkevich T. V. Grigorieva R. A. Khamitov |
| author_facet | E. V. Zuev O. L. Evdokimova O. A. Markova I. A. Korotkevich T. V. Grigorieva R. A. Khamitov |
| author_sort | E. V. Zuev |
| collection | DOAJ |
| description | Scientific relevance. Intranasal vaccination may dramatically change current approaches to mass immunisation against various infections, shifting the focus from inducing systemic humoral and cellular immune responses to developing mucosal immunity and protective barriers on the mucous membranes, which are entry points for pathogens. Therefore, the safety of switching from intramuscular to intranasal vaccination should be evaluated.Aim. This study aimed to compare the safety of intranasal and intramuscular vaccination using the intermediate results of the phase III VCI-COV-III clinical trial in healthy volunteers.Materials and methods. The evaluation of the safety profile was based on the adverse events and adverse drug reactions (ADRs) documented by investigators in the interim report on the randomised, double-blind clinical trial of the Salnavac intranasal vaccine (InV) and the Gam-COVID-Vac intramuscular vaccine (ImV) against coronavirus infection. The report covered 42 days of observation in 137 healthy volunteers.Results. ADRs were reported for 17/68 (25%) and 30/69 (43.5%) volunteers in the InV group and the ImV group, respectively (p=0.036). The ADRs reported for the InV group were systemic and local, short-term, mostly mild, and generally consistent in incidence and nature with the ADRs typically observed with other nasal products.Conclusions. According to the preliminary data obtained in the clinical trial, the InV demonstrates a high level of safety. Its safety profile is comparable with those of other intranasal and intramuscular vaccines for the prevention of coronavirus infection. |
| first_indexed | 2024-03-08T21:43:21Z |
| format | Article |
| id | doaj.art-baa6ef9846c74f43b0c135803f7d7b34 |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:12:09Z |
| publishDate | 2023-10-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj.art-baa6ef9846c74f43b0c135803f7d7b342024-03-26T09:10:54ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562023-10-0123327528910.30895/2221-996X-2023-23-431329Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infectionE. V. Zuev0O. L. Evdokimova1O. A. Markova2I. A. Korotkevich3T. V. Grigorieva4R. A. Khamitov5GENERIUM JSCGENERIUM JSCGENERIUM JSCGENERIUM JSCGENERIUM JSCGENERIUM JSCScientific relevance. Intranasal vaccination may dramatically change current approaches to mass immunisation against various infections, shifting the focus from inducing systemic humoral and cellular immune responses to developing mucosal immunity and protective barriers on the mucous membranes, which are entry points for pathogens. Therefore, the safety of switching from intramuscular to intranasal vaccination should be evaluated.Aim. This study aimed to compare the safety of intranasal and intramuscular vaccination using the intermediate results of the phase III VCI-COV-III clinical trial in healthy volunteers.Materials and methods. The evaluation of the safety profile was based on the adverse events and adverse drug reactions (ADRs) documented by investigators in the interim report on the randomised, double-blind clinical trial of the Salnavac intranasal vaccine (InV) and the Gam-COVID-Vac intramuscular vaccine (ImV) against coronavirus infection. The report covered 42 days of observation in 137 healthy volunteers.Results. ADRs were reported for 17/68 (25%) and 30/69 (43.5%) volunteers in the InV group and the ImV group, respectively (p=0.036). The ADRs reported for the InV group were systemic and local, short-term, mostly mild, and generally consistent in incidence and nature with the ADRs typically observed with other nasal products.Conclusions. According to the preliminary data obtained in the clinical trial, the InV demonstrates a high level of safety. Its safety profile is comparable with those of other intranasal and intramuscular vaccines for the prevention of coronavirus infection.https://www.biopreparations.ru/jour/article/view/494coronavirus infectioncovid-19sars-cov-2immunisationvaccineintranasal vaccinationmucosal immunitysafetyadverse eventsadverse drug reactions |
| spellingShingle | E. V. Zuev O. L. Evdokimova O. A. Markova I. A. Korotkevich T. V. Grigorieva R. A. Khamitov Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infection Биопрепараты: Профилактика, диагностика, лечение coronavirus infection covid-19 sars-cov-2 immunisation vaccine intranasal vaccination mucosal immunity safety adverse events adverse drug reactions |
| title | Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infection |
| title_full | Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infection |
| title_fullStr | Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infection |
| title_full_unstemmed | Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infection |
| title_short | Comparative safety evaluation of intranasal and intramuscular immunisation with Ad26 and Ad5-vectored vaccines to prevent coronavirus infection |
| title_sort | comparative safety evaluation of intranasal and intramuscular immunisation with ad26 and ad5 vectored vaccines to prevent coronavirus infection |
| topic | coronavirus infection covid-19 sars-cov-2 immunisation vaccine intranasal vaccination mucosal immunity safety adverse events adverse drug reactions |
| url | https://www.biopreparations.ru/jour/article/view/494 |
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