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Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults.
Hum Vaccin Immunother. 2018 03 04; 14(3):579-586.HV

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 18-45 years, 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 (15 μg 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 21 days 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.

Authors+Show Affiliations

a Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade , Belgrade , Serbia.a Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade , Belgrade , Serbia.b Diagnostics and Research and Development, Institute of Virology, Vaccines and Sera "Torlak" , Belgrade , Serbia.c Center for Vaccine Innovation and Access, PATH , Seattle , WA , USA.b Diagnostics and Research and Development, Institute of Virology, Vaccines and Sera "Torlak" , Belgrade , Serbia.c Center for Vaccine Innovation and Access, PATH , Seattle , WA , USA.d Universal Health Coverage and Health Systems, The World Health Organization , Geneva , Switzerland.e Managing Director of the Institute of Virology, Vaccines and Sera "Torlak" , Belgrade , Serbia.d Universal Health Coverage and Health Systems, The World Health Organization , Geneva , Switzerland.c Center for Vaccine Innovation and Access, PATH , Seattle , WA , USA.f Center for Vaccine Innovation and Access, PATH , Geneva , Switzerland.a Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade , Belgrade , Serbia.g Comac Medical , Sofia , Bulgaria.a Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade , Belgrade , Serbia.c Center for Vaccine Innovation and Access, PATH , Seattle , WA , USA.

Pub Type(s)

Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

29239682

Citation

Stevanovic, Goran, et al. "Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Influenza Vaccine: a Phase I Randomized Clinical Trial in Healthy Serbian Adults." Human Vaccines & Immunotherapeutics, vol. 14, no. 3, 2018, pp. 579-586.
Stevanovic G, Lavadinovic L, Filipovic Vignjevic S, et al. Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults. Hum Vaccin Immunother. 2018;14(3):579-586.
Stevanovic, G., Lavadinovic, L., Filipovic Vignjevic, S., Holt, R., Ilic, K., Berlanda Scorza, F., Sparrow, E., Stoiljkovic, V., Torelli, G., Madenwald, T., Socquet, M., Barac, A., Ilieva-Borisova, Y., Pelemis, 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. Human Vaccines & Immunotherapeutics, 14(3), 579-586. https://doi.org/10.1080/21645515.2017.1415683
Stevanovic G, et al. Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Influenza Vaccine: a Phase I Randomized Clinical Trial in Healthy Serbian Adults. Hum Vaccin Immunother. 2018 03 4;14(3):579-586. PubMed PMID: 29239682.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults. AU - Stevanovic,Goran, AU - Lavadinovic,Lidija, AU - Filipovic Vignjevic,Svetlana, AU - Holt,Renée, AU - Ilic,Katarina, AU - Berlanda Scorza,Francesco, AU - Sparrow,Erin, AU - Stoiljkovic,Vera, AU - Torelli,Guido, AU - Madenwald,Tamra, AU - Socquet,Muriel, AU - Barac,Aleksandra, AU - Ilieva-Borisova,Yordanka, AU - Pelemis,Mijomir, AU - Flores,Jorge, Y1 - 2018/02/23/ PY - 2017/12/15/pubmed PY - 2019/1/3/medline PY - 2017/12/15/entrez KW - Seasonal influenza vaccine KW - Serbia KW - Torlak KW - clinical trial KW - trivalent inactivated split SP - 579 EP - 586 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 14 IS - 3 N2 - 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 18-45 years, 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 (15 μg 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 21 days 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/29239682/Safety_and_immunogenicity_of_a_seasonal_trivalent_inactivated_split_influenza_vaccine:_a_phase_I_randomized_clinical_trial_in_healthy_Serbian_adults_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1415683 DB - PRIME DP - Unbound Medicine ER -