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dc.creatorStevanović, Goran
dc.creatorLavadinović, Lidija
dc.creatorFilipović-Vignjević, Svetlana
dc.creatorHolt, Renee
dc.creatorIlić, Katarina
dc.creatorScorza, Francesco Berlanda
dc.creatorSparrow, Erin
dc.creatorStoiljković, Vera
dc.creatorTorelli, Guido
dc.creatorMadenwald, Tamra
dc.creatorSocquet, Muriel
dc.creatorBarac, Aleksandra
dc.creatorIlieva-Borisova, Yordanka
dc.creatorPelemiš, Mijomir
dc.creatorFlores, Jorge
dc.date.accessioned2021-02-18T10:50:24Z
dc.date.available2021-02-18T10:50:24Z
dc.date.issued2018
dc.identifier.issn2164-5515
dc.identifier.urihttp://intor.torlakinstitut.com/handle/123456789/517
dc.description.abstractThis study was a phase I double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a Serbian-produced seasonal trivalent split, inactivated influenza vaccine in healthy adults. The vaccine was manufactured in eggs by the Torlak Institute of Virology, Vaccines and Sera, Belgrade, Serbia and contained A/H1N1, A/H3N2 and B viruses. The clinical trial took place at the Clinical Center of Serbia in Belgrade. Sixty healthy volunteers, aged 18-45years, were enrolled in the trial. On the day of immunization, volunteers were randomly assigned to receive either a single dose of the trivalent seasonal influenza vaccine (15g of hemagglutinin per strain) or placebo (phosphate-buffered saline). Subjects were monitored for adverse events through a clinical history and physical examination, and blood was taken for testing at screening and on day 8 to assess vaccine safety. Serum samples obtained before and 21days after immunization were tested for influenza antibody titers using hemagglutination-inhibition (HAI) and microneutralization (MN) tests. No serious adverse events were reported. Pain and tenderness at the injection site were the most commonly reported symptoms in both vaccine and placebo groups. Overall, serum HAI responses of fourfold or greater magnitude were observed to H1, H3, and B antigen in 80%, 75%, and 70% of subjects, respectively. Seroprotection rates as measured by HAI were also high (100%, 100% and 86.67%, respectively, for H1, H3 and B). Thus, Torlak's seasonal trivalent influenza vaccine was not associated with adverse events, was well-tolerated and immunogenic. It should be further evaluated in clinical trials to provide sufficient safety and immunogenicity data for licensing in Serbia.en
dc.publisherTaylor & Francis Inc, Philadelphia
dc.relationUS Department of Health and Human Services/BARDA [IDSEP130015-01, IDSEP130018-01-06]
dc.rightsopenAccess
dc.sourceHuman Vaccines & Immunotherapeutics
dc.subjectSeasonal influenza vaccineen
dc.subjecttrivalent inactivated spliten
dc.subjectclinical trialen
dc.subjectSerbiaen
dc.subjectTorlaken
dc.titleSafety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adultsen
dc.typearticle
dc.rights.licenseARR
dc.citation.epage586
dc.citation.issue3
dc.citation.other14(3): 579-586
dc.citation.rankM22
dc.citation.spage579
dc.citation.volume14
dc.identifier.doi10.1080/21645515.2017.1415683
dc.identifier.fulltexthttp://intor.torlakinstitut.com/bitstream/id/336/514.pdf
dc.identifier.pmid29239682
dc.identifier.rcubconv_427
dc.identifier.scopus2-s2.0-85042401465
dc.identifier.wos000428053800021
dc.type.versionpublishedVersion


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