Phase I Clinical Study of the Subunit Betulin-Adjuvanted Tetravalent Candidate Influenza Vaccine TetraFluBet.

Autor:	Krasilnikov I; CJSC Biotechnology Developments, 119136 Moscow, Russia., Tcymbarevich I; CJSC Biotechnology Developments, 119136 Moscow, Russia., Krasheninnikova A; CJSC Biotechnology Developments, 119136 Moscow, Russia., Sukhova M; CJSC Biotechnology Developments, 119136 Moscow, Russia., Ivanov A; CJSC Biotechnology Developments, 119136 Moscow, Russia., Stukova M; Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia., Romanovskaya-Romanko E; Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia., Zubkova T; Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia., Mironov A; CRO 'CTR-Pharma', 119311 Moscow, Russia., Lioznov D; Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia.
Jazyk:	angličtina
Zdroj:	Vaccines [Vaccines (Basel)] 2024 Sep 05; Vol. 12 (9). Date of Electronic Publication: 2024 Sep 05.
DOI:	10.3390/vaccines12091017
Abstrakt:	Objectives: This study aimed to determine the safety, tolerability and immunogenicity of TetraFluBet, an inactivated subunit influenza vaccine that contains a corpuscular immuno-adjuvant derived from natural betulin. Methods: We conducted a prospective, randomized, open-labeled, single-center, phase I trial. The study was conducted in two stages: 5 volunteers in stage I and 25 volunteers in stage II. Eligible participants received one single dose (20 μg/0.5 mL) of TetraFluBet intramuscularly. Participants were followed for adverse events and reactogenicity. Seroconversion rate, seroprotection level, geometric mean titers (GMTs) of virus-neutralizing antibodies, IFN-γ induction and cell-mediated immunity were assessed. Results: A total of 30 participants were enrolled. No vaccine-related serious adverse events were observed. The proportions of study participants with 4-fold seroconversions assessed by the HI assay (with 95% CIs) were 80.0% (62.7; 90.5), 70.0% (52.1; 83.3), 63.3% (45.5; 78.1) and 73.3% (55.6; 85.8) for influenza virus subtypes A (H1N1), A (H3N2), B1 and B2, respectively. Seroprotection levels (with 95% CIs) were 83.3% (66.4; 92.7), 83.3% (66.4; 92.7), 73.3% (55.6; 85.8) and 66.7% (48.8; 80.8), respectively. The fold increases in the GMTs of virus-neutralizing antibodies for subtype H1N1 was 6.50, for subtype H3N2 was 3.03, for subtype B1 was 3.56 and for subtype B2 was 6.07. The population of cytotoxic T-cells increased significantly in the post-vaccination period, indicating a strong CD3 + CD8 + response. Conclusions: TetraFluBet tetravalent inactivated subunit vaccine with adjuvant demonstrated pronounced immunogenic properties, leading to the formation of both specific humoral and cellular immunity at a 20 μg dose. Competing Interests: The authors declare no conflicts of interest.
Databáze:	MEDLINE
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