IMMUNOGENICITY OF THE THIRD GENERATION HEPATITIS B VACCINE (pre-S1/pre-S2/S)

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Abstract

Currently, second-generation hepatitis B vaccines are widely used. They are produced in biotechnological eukaryotic yeast-based systems and contain the S-protein domain of HBsAg particle in the complete absence of pre-S1 and pre-S2 domains. At the same time, these antigens were proved to significantly influence immunogenicity, which makes the development and use of third-generation vaccines containing all antigenic determinants a long-range objective. A randomized, double-blind clinical study was conducted to compare immunogenicity of second- and third-generation vaccines Engerix-B™ and Sci-B-Vac™, respectively. Healthy subjects of both sexes aged 18 to 45 years (n = 94) who are seronegative for HBsAg, HBsAb, HBcAb at screening and who previously had not received immunobiological agents for hepatitis B prophylaxis were included in the study. Group I (n = 47) received the second-generation vaccine Engerix-B™, Group II (n = 47) — the third-generation vaccine Sci-B-Vac™. Subjects received vaccines three times — on days 1, 28 and 180 of the study. HBsAb levels, rates of seroconversion (the proportion of subjects with HBsAb levels > 2.1 mIU/mL) and seroprotection (the proportion of subjects with HBsAb levels ≥ 10 mIU/mL) were assessed on days 28, 90, 180 and 210 of the study. Early seroconversion rate assessed on Day 28 was 76.60% in Group I and 93.88% in Group II (p < 0.05); seroprotection rate was 51.06 and 61.22%, respectively. These differences in the proportion of subjects who achieved seroconversion on Day 28 may indicate a faster immunological response to Sci-B-Vac™ vaccine. Statistically significant differences between the level of antibodies on days 90 and 180 (p < 0.05) were observed when analyzing the average values of HBsAb concentration in Groups I and II. The concentration of HBsAb on Day 90 was 378.68±60.95 mIU/mL in Group I, and 618.31±58.34 mIU/mL in Group II. On Day 180, the concentration of HBsAb reached 441.34±63.83 mIU/mL in Group I, and 757.72±55.14 mIU/mL in Group II. The significance of dependence of antibody level on sex, age and body weight was analyzed. It was revealed that the age of a vaccinated subject affects antibody level after administration of Engerix-B™ (p < 0.05). The results obtained suggest that there is a rapid and strong immune response to the third-generation vaccine Sci-B-Vac™. This may indicate advantage of the vaccine containing all three recombinant proteins of hepatitis B virus envelope, which, in turn, can play a key role in clinical practice for urgent prophylaxis of hepatitis B, as well as for treatment of immunocompromised conditions.

About the authors

E. V. Esaulenko

St. Petersburg State Pediatric Medical University

Author for correspondence.
Email: infection-gpmu@mail.ru

Elena V. Esaulenko - PhD, MD (Medicine), Professor, Head of Adult Infection Diseases and Epidemiology Department

194100, St. Petersburg, Litovskaya str., 2, Phone: +7 (812) 274-90-65

Russian Federation

A. A. Sukhoruk

St. Petersburg State Pediatric Medical University

Email: fake@neicon.ru

PhD (Medicine), Professor Assistant of Adult Infection Diseases and Epidemiology Department

Russian Federation

K. A. Zakharov

St. Petersburg State Pediatric Medical University

Email: fake@neicon.ru

Postgraduate Student at Adult Infection Diseases and Epidemiology Department

Russian Federation

A. A. Yakovlev

Clinical Infection Hospital named after S.P. Botkin

Email: fake@neicon.ru

PhD, MD (Medicine), Professor, Head of Infection Diseases, Epidemiology, Dermatology and Venerology Department St.PSU; Chief Physician at CIH named after S.P. Botkin

Russian Federation

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