Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia.

Autor: Dolzhikova IV; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Zubkova OV; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Tukhvatulin AI; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Dzharullaeva AS; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Tukhvatulina NM; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Shcheblyakov DV; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Shmarov MM; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Tokarskaya EA; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Simakova YV; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Egorova DA; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Scherbinin DN; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Tutykhina IL; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Lysenko AA; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Kostarnoy AV; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Gancheva PG; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Ozharovskaya TA; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Belugin BV; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Kolobukhina LV; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Pantyukhov VB; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Syromyatnikova SI; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Shatokhina IV; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Sizikova TV; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Rumyantseva IG; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Andrus AF; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Boyarskaya NV; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Voytyuk AN; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Babira VF; d No. 7 Main Military Clinical Hospital named after academician N. N. Burdenko , Ministry of Defense , Posad-7, Russia., Volchikhina SV; d No. 7 Main Military Clinical Hospital named after academician N. N. Burdenko , Ministry of Defense , Posad-7, Russia., Kutaev DA; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Bel'skih AN; b Military Medical Academy named after S. M. Kirov , Ministry of Defense , Saint Petersburg , Russia., Zhdanov KV; b Military Medical Academy named after S. M. Kirov , Ministry of Defense , Saint Petersburg , Russia., Zakharenko SM; b Military Medical Academy named after S. M. Kirov , Ministry of Defense , Saint Petersburg , Russia., Borisevich SV; c 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia., Logunov DY; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Naroditsky BS; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia., Gintsburg AL; a Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
Jazyk: angličtina
Zdroj: Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2017 Mar 04; Vol. 13 (3), pp. 613-620. Date of Electronic Publication: 2017 Feb 02.
DOI: 10.1080/21645515.2016.1238535
Abstrakt: Ebola hemorrhagic fever, also known as Ebola virus disease or EVD, is one of the most dangerous viral diseases in humans and animals. In this open-label, dose-escalation clinical trial, we assessed the safety, side effects, and immunogenicity of a novel, heterologous prime-boost vaccine against Ebola, which was administered in 2 doses to 84 healthy adults of both sexes between 18 and 55 years. The vaccine consists of live-attenuated recombinant vesicular stomatitis virus (VSV) and adenovirus serotype-5 (Ad5) expressing Ebola envelope glycoprotein. The most common adverse event was pain at the injection site, although no serious adverse events were reported. The vaccine did not significantly impact blood, urine, and immune indices. Seroconversion rate was 100 %. Antigen-specific IgG geometric mean titer at day 42 was 3,277 (95 % confidence interval 2,401-4,473) in volunteers immunized at full dose. Neutralizing antibodies were detected in 93.1 % of volunteers immunized at full dose, with geometric mean titer 20. Antigen-specific response in peripheral blood mononuclear cells was also detected in 100 % of participants, as well as in CD4+ and CD8+ T cells in 82.8 % and 58.6 % of participants vaccinated at full dose, respectively. The data indicate that the vaccine is safe and induces strong humoral and cellular immune response in up to 100 % of healthy adult volunteers, and provide a rationale for testing efficacy in Phase III trials. Indeed, the strong immune response to the vaccine may elicit long-term protection. This trial was registered with grls.rosminzdrav.ru (No. 495*), and with zakupki.gov.ru (No. 0373100043215000055).
Databáze: MEDLINE
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