Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults
Autori
Stevanović, GoranLavadinović, Lidija
Filipović-Vignjević, Svetlana
Holt, Renee
Ilić, Katarina
Scorza, Francesco Berlanda
Sparrow, Erin
Stoiljković, Vera
Torelli, Guido
Madenwald, Tamra
Socquet, Muriel
Barac, Aleksandra
Ilieva-Borisova, Yordanka
Pelemiš, Mijomir
Flores, Jorge
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
This 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 antibo...dy 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.
Ključne reči:
Seasonal influenza vaccine / trivalent inactivated split / clinical trial / Serbia / TorlakIzvor:
Human Vaccines & Immunotherapeutics, 2018, 14, 3, 579-586Izdavač:
- Taylor & Francis Inc, Philadelphia
Finansiranje / projekti:
- US Department of Health and Human Services/BARDA [IDSEP130015-01, IDSEP130018-01-06]
DOI: 10.1080/21645515.2017.1415683
ISSN: 2164-5515
PubMed: 29239682
WoS: 000428053800021
Scopus: 2-s2.0-85042401465
Institucija/grupa
TorlakTY - JOUR AU - Stevanović, Goran AU - Lavadinović, Lidija AU - Filipović-Vignjević, Svetlana AU - Holt, Renee AU - Ilić, Katarina AU - Scorza, Francesco Berlanda AU - Sparrow, Erin AU - Stoiljković, Vera AU - Torelli, Guido AU - Madenwald, Tamra AU - Socquet, Muriel AU - Barac, Aleksandra AU - Ilieva-Borisova, Yordanka AU - Pelemiš, Mijomir AU - Flores, Jorge PY - 2018 UR - http://intor.torlakinstitut.com/handle/123456789/517 AB - This 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. PB - Taylor & Francis Inc, Philadelphia T2 - Human Vaccines & Immunotherapeutics T1 - Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults EP - 586 IS - 3 SP - 579 VL - 14 DO - 10.1080/21645515.2017.1415683 ER -
@article{ author = "Stevanović, Goran and Lavadinović, Lidija and Filipović-Vignjević, Svetlana and Holt, Renee and Ilić, Katarina and Scorza, Francesco Berlanda and Sparrow, Erin and Stoiljković, Vera and Torelli, Guido and Madenwald, Tamra and Socquet, Muriel and Barac, Aleksandra and Ilieva-Borisova, Yordanka and Pelemiš, Mijomir and Flores, Jorge", year = "2018", abstract = "This 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.", publisher = "Taylor & Francis Inc, Philadelphia", journal = "Human Vaccines & Immunotherapeutics", title = "Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults", pages = "586-579", number = "3", volume = "14", doi = "10.1080/21645515.2017.1415683" }
Stevanović, G., Lavadinović, L., Filipović-Vignjević, S., Holt, R., Ilić, K., Scorza, F. B., Sparrow, E., Stoiljković, V., Torelli, G., Madenwald, T., Socquet, M., Barac, A., Ilieva-Borisova, Y., Pelemiš, M.,& Flores, J.. (2018). Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults. in Human Vaccines & Immunotherapeutics Taylor & Francis Inc, Philadelphia., 14(3), 579-586. https://doi.org/10.1080/21645515.2017.1415683
Stevanović G, Lavadinović L, Filipović-Vignjević S, Holt R, Ilić K, Scorza FB, Sparrow E, Stoiljković V, Torelli G, Madenwald T, Socquet M, Barac A, Ilieva-Borisova Y, Pelemiš M, Flores J. Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults. in Human Vaccines & Immunotherapeutics. 2018;14(3):579-586. doi:10.1080/21645515.2017.1415683 .
Stevanović, Goran, Lavadinović, Lidija, Filipović-Vignjević, Svetlana, Holt, Renee, Ilić, Katarina, Scorza, Francesco Berlanda, Sparrow, Erin, Stoiljković, Vera, Torelli, Guido, Madenwald, Tamra, Socquet, Muriel, Barac, Aleksandra, Ilieva-Borisova, Yordanka, Pelemiš, Mijomir, Flores, Jorge, "Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults" in Human Vaccines & Immunotherapeutics, 14, no. 3 (2018):579-586, https://doi.org/10.1080/21645515.2017.1415683 . .