Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children

Raz, Raul; Dagan, Ron; Gallil, Aharon; Brill, Gherta; Kassis, Imad; Koren, Ronit

doi:10.1016/0264-410x(95)00185-4

Cited by 59 publications

(40 citation statements)

References 17 publications

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“…Anti-HBs titers were higher by approximately one order of magnitude than those reported for yeast-derived vaccines. In neonates and children similar results were obtained with the Bio-Hep-B ® vaccine [14, 15]. …”

Section: Discussionsupporting

confidence: 62%

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Improved Immunogenicity of a Novel Third-Generation Recombinant Hepatitis B Vaccine in Patients with End-Stage Renal Disease

Weinstein

Chagnac²,

Boaz³

et al. 2004

Nephron Clin Pract

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Hepatitis B (HBV) infection remains a significant epidemiological problem in the end-stage renal disease (ESRD) population. Vaccination programs using second-generation vaccines lead to effective seroprotection in only 50–60% of these patients. The purpose of this case series was to describe our experience with a novel third-generation vaccine, Bio-Hep-B^®, in ESRD patients who had not developed protective anti-HBs titers following a second-generation HBV vaccination protocol. Twenty-nine ESRD patients who had not responded in the past to a standard second-generation HBV vaccination protocol were included in this series. Each patient received 10 µg of Bio-Hep-B^® intramuscularly at 0, 1 and 6 months. A month after completion of the vaccination protocol, anti-HBs antibody levels were measured. Following immunization, 25 of 29 patients (86%) developed seroprotective anti-HBs levels ≧10 mIU/ml. There was a significant difference in the titers of anti-HBs antibodies prior to and following vaccination (p < 0.0001). Statistical analysis of the variables age, gender, diagnosis, dialysis mode, weight, hemoglobin, albumin, and KT/V failed to detect predictors of antibody response. A retrospective analysis of the results of a second-generation vaccination program for the years 1999–2001 in our department showed that 19 of 36 (56.4%) ESRD patients developed seroprotection. In conclusion, the results of this study show that the third-generation HBV vaccine Bio-Hep-B^® is highly immunogenic in the population of ESRD patients who did not respond in the past to a second-generation vaccine. This enhanced seroprotection offers hope that the new vaccine will reduce the rate of non-responders and help to eliminate HBV infection from dialysis centers.

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Section: Discussionsupporting

confidence: 62%

“…The process yields 22-nm particles purified from culture medium, which harbor all antigenic epitopes and antigens of the HBV envelope and resemble its glycosylation pattern. This vaccine has been proved tolerable and highly immunogenic in neonates, children and adults [14, 15, 16]. …”

Section: Introductionmentioning

confidence: 99%

Improved Immunogenicity of a Novel Third-Generation Recombinant Hepatitis B Vaccine in Patients with End-Stage Renal Disease

Weinstein

Chagnac²,

Boaz³

et al. 2004

Nephron Clin Pract

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“…However, BNC (targeting molecule of virosomes) has already been shown as a safe biomaterial in humans. 30,31 And, the LP-DOX complexes (ie, Doxil, DOXOVES) have also been confirmed safe in human. 26 It was therefore considered that the virosomes containing DOX are not cytotoxic in vivo.…”

Section: Cytotoxicity Of Virosomes Containing Doxmentioning

confidence: 95%

Virosomes of hepatitis B virus envelope L proteins containing doxorubicin: synergistic enhancement of human liver-specific antitumor growth activity by radiotherapy

Liu¹,

Jung²,

Somiya³

et al. 2015

IJN

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Bionanocapsules (BNCs) are hollow nanoparticles consisting of hepatitis B virus (HBV) envelope L proteins and have been shown to deliver drugs and genes specifically to human hepatic tissues by utilizing HBV-derived infection machinery. The complex of BNCs with liposomes (LPs), the BNC–LP complexes (a LP surrounded by BNCs in a rugged spherical form), could also become active targeting nanocarriers by the BNC function. In this study, under acidic conditions and high temperature, BNCs were found to fully fuse with LPs (smooth-surfaced spherical form), deploying L proteins with a membrane topology similar to that of BNCs (ie, virosomes displaying L proteins). Doxorubicin (DOX) was efficiently encapsulated via the remote loading method at 14.2%±1.0% of total lipid weight (mean ± SD, n=3), with a capsule size of 118.2±4.7 nm and a ζ-potential of −51.1±1.0 mV (mean ± SD, n=5). When mammalian cells were exposed to the virosomes, the virosomes showed strong cytotoxicity in human hepatic cells (target cells of BNCs), but not in human colon cancer cells (nontarget cells of BNCs), whereas LPs containing DOX and DOXOVES (structurally stabilized PEGylated LPs containing DOX) did not show strong cytotoxicity in either cell type. Furthermore, the virosomes preferentially delivered DOX to the nuclei of human hepatic cells. Xenograft mice harboring either target or nontarget cell-derived tumors were injected twice intravenously with the virosomes containing DOX at a low dose (2.3 mg/kg as DOX, 5 days interval). The growth of target cell-derived tumors was retarded effectively and specifically. Next, the combination of high dose (10.0 mg/kg as DOX, once) with tumor-specific radiotherapy (3 Gy, once after 2 hours) exhibited the most effective antitumor growth activity in mice harboring target cell-derived tumors. These results demonstrated that the HBV-based virosomes containing DOX could be an effective antitumor nanomedicine specific to human hepatic tissues, especially in combination with radiotherapy.

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“…Следует отметить, что в ходе разработки вакцины Sci-B-Vac™, ее повышенная имму-ногенность была доказана в ряде контроли-руемых сравнительных исследований, прове-денных с участием детей и взрослых, а также в особых группах пациентов (пациенты с им-муносупрессией, страдающие почечной недо-статочностью, а также лица, не отвечающие на вакцины второго поколения) [7,8,12,22,23,26,27,32,33,34,35], что отражает ее особое значение при использовании у иммуноком-прометированных лиц, а также при необходи-мости осуществления мер экстренной профи-лактики ГВ [16,25].…”

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

Эсауленко¹,

Сухорук²,

Zakharov³

et al. 2018

Russian Journal of Infection and Immunity

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Резюме. В настоящее время широко используются вакцины против гепатита В второго поколения, получаемые в биотехнологических эукариотических системах на основе дрожжей и содержащие S-белковый домен частицы HBsAg при полном отсутствии доменов pre-S1 и pre-S2. Вместе с тем доказано, что именно эти антигены могут значительно влиять на иммуногенность, что делает разработку и использование вакцин третьего поколения, со-держащих все антигенные детерминанты, перспективной задачей. Для сравнительного изучения иммуногеннос-ти вакцин второго и третьего поколений Engerix-B™ и Sci-B-Vac™ было проведено рандомизированное двойное слепое клиническое исследование. В исследование были включены здоровые лица обоих полов в возрасте от 18 до 45 лет (n = 94), cеронегативные в отношении HBsAg, HBsAb, HBcAb при скрининге и ранее не получавшие им-мунобиологические средства профилактики гепатита В. В группу I (n = 47) вошли лица, получившие вакцину второго поколения Engerix-B™, в группу II (n = 47) -вакцину третьего поколения Sci-B-Vac™. Вакцинация осу-ществлялась трехкратно -в 1, 28 и 180 дни исследования. Концентрация HBsAb, показатели сероконверсии (доля лиц с концентрацией HBsAb > 2,1 мМЕ/мл) и серопротекции (доля лиц с концентрацией HBsAb ≥ 10 мМЕ/мл) оценивались на 28, 90, 180 и 210 день исследования. При оценке показателя ранней сероконверсии на 28 день ис-следования установлено, что он составил 76,60% в группе I и 93,88% в группе II (p < 0,05); показатель серопротек-ции составил 51,06 и 61,22% соответственно. Данные различия в отношении доли лиц, достигших сероконвер-сии на 28 день исследования, могут свидетельствовать о наступлении более быстрого иммунологического ответа на введение вакцины Sci-B-Vac™. При анализе средних значений концентрации HBsAb в группах I и II были полу-чены данные о наличии статистически значимых различий между уровнем антител на 90 и 180 день исследования (p < 0,05). На 90 день исследования в группе I концентрация HBsAb составила 378,68±60,95 мМЕ/мл, в группе II -618,31±58,34 мМЕ/мл. На 180 день исследования в группе I концентрация HBsAb достигла 441,34±63,83 мМЕ/ мл, в группе II -757,72±55,14 мМЕ/мл. Проведенный анализ значимости зависимости уровня антител от пола, возраста и массы тела выявил, что возраст вакцинированного влияет на концентрацию антител после вакцина-ции Engerix-B™ (р < 0,05). Таким образом, полученные результаты позволяют сделать вывод о наличии быстрого и сильного иммунного ответа на введение вакцины третьего поколения Sci-B-Vac™, что может свидетельствовать о преимуществе вакцины, содержащей все три рекомбинантных белка оболочки вируса гепатита В, что, в свою очередь, может сыграть решающую роль в клинической практике при экстренной профилактике гепатита В, а также при использовании у пациентов с иммунокомпроментированными состояниями.Ключевые слова : вакцина, гепатит В, иммуногенность, сероконверсия, серопротекция,

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Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children

Cited by 59 publications

References 17 publications

Improved Immunogenicity of a Novel Third-Generation Recombinant Hepatitis B Vaccine in Patients with End-Stage Renal Disease

Improved Immunogenicity of a Novel Third-Generation Recombinant Hepatitis B Vaccine in Patients with End-Stage Renal Disease

Virosomes of hepatitis B virus envelope L proteins containing doxorubicin: synergistic enhancement of human liver-specific antitumor growth activity by radiotherapy

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

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Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children

Cited by 59 publications

References 17 publications

Improved Immunogenicity of a Novel Third-Generation Recombinant Hepatitis B Vaccine in Patients with End-Stage Renal Disease

Improved Immunogenicity of a Novel Third-Generation Recombinant Hepatitis B Vaccine in Patients with End-Stage Renal Disease

Virosomes of hepatitis B virus envelope L&nbsp;proteins containing doxorubicin: synergistic enhancement of human liver-specific antitumor growth activity by radiotherapy

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

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Virosomes of hepatitis B virus envelope L proteins containing doxorubicin: synergistic enhancement of human liver-specific antitumor growth activity by radiotherapy