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

Dolzhikova, Inna V.; Zubkova, Olga V.; Tukhvatulin, Amir I.; Dzharullaeva, Alina S.; Tukhvatulina, N. M.; Shcheblyakov, Dmitry V.; Шмаров, М. М.; Tokarskaya, Elizaveta A.; Simakova, Yana V.; Егорова, Д.А.; Scherbinin, D N; Тутыхина, И. Л.; Лысенко, А. А.; Kostarnoy, Alexey V; Gancheva, Petya G.; Ozharovskaya, Tatiana A; Belugin, B. V.; Колобухина, Л. В.; Pantyukhov, V. B.; Syromyatnikova, S. I.; Shatokhina, Iuliia; Sizikova, T. V.; Rumyantseva, Irina; Andrus, A. F.; Boyarskaya, N. V.; Voytyuk, A. N.; Babira, V. F.; Volchikhina, S. V.; Кутаев, Д. А.; Bel'skih, A. N.; Жданов, К. В.; Захаренко, С. М.; Borisevich, S. V.; Logunov, Denis Y.; Naroditsky, Boris S.; Gintsburg, A. L.

doi:10.1080/21645515.2016.1238535

Cited by 99 publications

(78 citation statements)

References 18 publications

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“…Previously our group has successfully used Ad5 for design of vaccines against influenza [10], Bacillus anthracis [65], Ebola virus [30, 31], and some other pathogens. Ad5 vectors are commonly used among the adenoviruses due to a wide range of their well-described attractive features.…”

Section: Discussionmentioning

confidence: 99%

“…The safety of adenoviral vaccines is another question that should be addressed, especially for widespread diseases like Chlamydia infection. Recently, our group published the results of successful clinical trial of Ad5-based Ebola vaccine candidate that confirmed safety of this vaccine [30, 31]. Adenovirus-based influenza vaccine has successfully passed phase I clinical trials in the USA and proved to be safe for humans and highly immunogenic for the influenza A H5N2 virus [67].…”

Section: Discussionmentioning

confidence: 99%

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Chlamydial Type III Secretion System Needle Protein Induces Protective Immunity againstChlamydia muridarumIntravaginal Infection

Koroleva

Kobets

Щербинин

et al. 2017

BioMed Research International

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Chlamydia trachomatis imposes serious health problems and causes infertility. Because of asymptomatic onset, it often escapes antibiotic treatment. Therefore, vaccines offer a better option for the prevention of unwanted inflammatory sequelae. The existence of serologically distinct serovars of C. trachomatis suggests that a vaccine will need to provide protection against multiple serovars. Chlamydia spp. use a highly conserved type III secretion system (T3SS) composed of structural and effector proteins which is an essential virulence factor. In this study, we expressed the T3SS needle protein of Chlamydia muridarum, TC_0037, an ortholog of C. trachomatis CdsF, in a replication-defective adenoviral vector (AdTC_0037) and evaluated its protective efficacy in an intravaginal Chlamydia muridarum model. For better immune responses, we employed a heterologous prime-boost immunization protocol in which mice were intranasally primed with AdTC_0037 and subcutaneously boosted with recombinant TC_0037 and Toll-like receptor 4 agonist monophosphoryl lipid A mixed in a squalene nanoscale emulsion. We found that immunization with TC_0037 antigen induced specific humoral and T cell responses, decreased Chlamydia loads in the genital tract, and abrogated pathology of upper genital organs. Together, our results suggest that TC_0037, a highly conserved chlamydial T3SS protein, is a good candidate for inclusion in a Chlamydia vaccine.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Chlamydial Type III Secretion System Needle Protein Induces Protective Immunity againstChlamydia muridarumIntravaginal Infection

Koroleva

Kobets

Щербинин

et al. 2017

BioMed Research International

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“…Both rVSV and Ad26‐ZEBOV/MVA‐BN‐Filo prime‐boost vaccine have been evaluated in Phases I, II, and III clinical trials. Other nonreplicating vaccines are virus‐vector‐based evidenced to be highly effective in non‐human primates (NHPs) . The current study is focused on the therapeutic advancement towards EVD and the challenges encountered.…”

Section: Introductionmentioning

confidence: 99%

Perspectives towards antiviral drug discovery against Ebola virus

Mirza

Vanmeert

Ali

et al. 2019

Journal of Medical Virology

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Ebola virus disease (EVD), caused by Ebola viruses, resulted in more than 11 500 deaths according to a recent 2018 WHO report. With mortality rates up to 90%, it is nowadays one of the most deadly infectious diseases. However, no Food and Drug Administration‐approved Ebola drugs or vaccines are available yet with the mainstay of therapy being supportive care. The high fatality rate and absence of effective treatment or vaccination make Ebola virus a category‐A biothreat pathogen. Fortunately, a series of investigational countermeasures have been developed to control and prevent this global threat. This review summarizes the recent therapeutic advances and ongoing research progress from research and development to clinical trials in the development of small‐molecule antiviral drugs, small‐interference RNA molecules, phosphorodiamidate morpholino oligomers, full‐length monoclonal antibodies, and vaccines. Moreover, difficulties are highlighted in the search for effective countermeasures against EVD with additional focus on the interplay between available in silico prediction methods and their evidenced potential in antiviral drug discovery.

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“…20–22 The GamEvac-Combi vaccine (live-attenuated recombinant vesicular stomatitis virus and recombinant adenovirus type 5 expressing the envelope glycoprotein of Ebola virus/ H sapiens -wt/GIN/2014/Makona-C15 strain) was safe and induced strong humoral and cellular immune responses in up to 100% of 84 healthy adult volunteers. 23 …”

mentioning

confidence: 99%