Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.)(Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.))

概要

基本信息

药物类型

预防性疫苗

别名

Hepatitis A vaccine、Hepatitis A vaccine, inactivated、Inactivated hepatitis A vaccine

+ [4]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染消化系统疾病

在研适应症-

非在研适应症

甲型肝炎

原研机构

Boryung Corp.

在研机构-

非在研机构

Boryung Biopharma Co., Ltd.

权益机构-

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

6

项与 Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.) 相关的临床试验

NCT05613127

/ Unknown status临床3期

A Randomized, Double-blind, Multicenter, Multinational, Active-controlled, Parallel-designed Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24months to 15yrs

The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).

开始日期2022-12-01

申办/合作机构

Boryung Biopharma Co., Ltd.

CTRI/2019/04/018384

/ Completed临床3期IIT

A single blind, parallel, randomised Phase-III comparative study to evaluate safety and immunogenicity of two intramuscular doses of inactivated Hepatitis A vaccine administered 6 months apart, in 1-15 year-old healthy Hepatitis A vaccine-naïve children. - None

开始日期2019-04-12

申办/合作机构-

JPRN-UMIN000009351

/ CompletedN/AIIT

Interchangeability of hepatitis A vaccines - Interchangeability of hepatitis A vaccines

开始日期2012-11-21

申办/合作机构

Tokyo Medical University

[+1]

100 项与 Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.) 相关的临床结果

登录后查看更多信息

100 项与 Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.) 相关的转化医学

登录后查看更多信息

100 项与 Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.) 相关的专利（医药）

登录后查看更多信息

1,016

项与 Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.) 相关的文献（医药）

2025-04-01·International Journal of Rheumatic Diseases

The Efficacy and Safety of Hepatitis A Vaccine in Children and Young Adults With an Autoinflammatory Diseases on Canakinumab and Tocilizumab Treatments: A Prospective Observational Controlled Study

Article

作者: Barut, Kenan ; Kasapçopur, Özgür ; Gül, Ümit ; Akay, Nergis ; Mayda, Pelin Yüksel ; Gunalp, Aybuke ; Aslan, Esma ; Yildiz, Mehmet ; Adrovic, Amra ; Kocazeybek, Bekir ; Beşer, Ömer Faruk ; Sahin, Sezgin ; Haslak, Fatih ; Konte, Elif Kılıç

ABSTRACTIntroIn this prospective interventional study, we aimed to assess the efficacy and safety of the hepatitis A vaccine in patients with autoinflammatory diseases undergoing canakinumab and tocilizumab treatments.MethodsA total of 24 patients with autoinflammatory diseases on canakinumab and tocilizumab treatments and 39 healthy children who were seronegative for hepatitis A were included in the study. All participants were vaccinated with 2 doses of inactivated hepatitis A vaccine at 6‐month intervals. One month after the last vaccination, venous blood samples were collected from each participant, and the anti‐HAV IgM and IgG titers were measured.ResultsThe patient group consisted of 19 patients with systemic juvenile idiopathic arthritis (sJIA) and 5 patients with cryopyrin‐associated periodic fever. The mean age of the patient group and the healthy controls were 14.1 ± 3.7 and 12.4 ± 3.2 years, respectively. All patients with cryopyrin‐associated periodic fever and 52.6% (10/19) of the patients with sJIA were on canakinumab. The remaining 9 patients (47.3%) with sJIA were using tocilizumab. Among sJIA patients, 15 were also on methotrexate, and 14 were on prednisolone. All of the participants were negative for hepatitis A serology. After two doses of hepatitis A vaccine, all the patients with autoinflammatory diseases (24/24) and 84.6% (33/39) of the healthy controls were detected as positive for anti‐HAV IgG (p = 0.04). The mean anti‐HAV Ig G titers of the patient group and the control group one month after the last dose of vaccination were 5.25 ± 1.49 IU/L and 10.5 ± 7.02 IU/L, respectively (p < 0.001). Neither disease flares nor adverse effects related to vaccination were observed within the study period.ConclusionHepatitis A vaccine is effective and safe in children with autoinflammatory diseases on biologic therapy. Long‐term follow‐up data, including larger patient cohorts, are needed to draw a solid conclusion about the safety of hepatitis A vaccine in patients receiving canakinumab and tocilizumab therapy.

2025-03-27·Open Forum Infectious Diseases

Efficacy and Durability of Immune Response After Receipt of Hepatitis A Vaccine in People With Human Immunodeficiency Virus

Review

作者: Ofotokun, Ighovwerha ; Dib, Serena Maria ; Saint-Victor, Diane ; Naji, Amal ; Khalil, Lana ; Tandon Wimalasana, Sonia ; Rouphael, Nadine ; Kazzi, Bahaa

AbstractHepatitis A virus (HAV) infection is a serious health concern among people with human immunodeficiency virus (HIV). Coinfection with HAV and HIV is linked to increased hepatitis A viral load, elevated HIV RNA, and potential disruption of HIV treatment caused by liver dysfunction. Three vaccines for the prevention of HAV are currently approved for usage in the United States: 2 monovalent inactivated vaccines (hepatitis A vaccine, inactivated [GSK] and hepatitis A vaccine, inactivated [Merck]) and 1 hepatitis A (inactivated) and hepatitis B (recombinant) vaccine (GSK). Among people with HIV (PWH), seroconversion rates and antibody titers to HAV vaccines tend to be lower and less persistent than in immunocompetent individuals, with a notable difference among PWH with a lower CD4 cell count. We highlight in this review the potential need for serologic monitoring and revaccination strategies that would optimize lifelong protection against HAV in PWH.

2025-03-11·Journal of Travel Medicine

Hepatitis a vaccine immunogenicity and boostability in adults receiving immunosuppressive therapy and adults living with HIV: a prospective single-centre cohort study

Article

作者: Harskamp, Agnes M ; Maurer, Irma ; Tanck, Michael W ; Grobusch, Martin P ; Kootstra, Neeltje ; Goorhuis, Abraham ; Garcia Garrido, Hannah M ; Schnyder, Jenny L

AbstractIntroductionHepatitis A (hepA) vaccination is highly immunogenic in healthy individuals; however, there is uncertainty about the immunogenicity in immunocompromised populations (ICPs).MethodsIn this prospective cohort study, people living with HIV (PLWH), patients on immunosuppressive mono- and combination therapy, and controls received two hepA vaccine doses at months 0 and 6–12, or three combined hepA/B vaccine doses at months 0, 1 and 6–12. Antibody levels were measured before and at different time-points post-vaccination (T2, 6, 8, 12 months). The primary endpoint was the seroconversion rate (SCR) at T8, defined as hepA antibodies ≥20 mIU/ml. To assess boostability, an additional vaccine dose was administered 1–5 years after T12 in those with antibodies < 50 mIU/ml, with antibody measurements before and seven days after the booster dose.ResultsWe included 150 participants. At T2 SCRs ranged between 35–58% in ICPs versus 94% in controls. Among PLWH, patients on monotherapy, combination therapy and controls SCRs at T8 were 33/34 (97%), 32/34 (94%), 25/30 (83%) and 28/28 (100%), respectively. The booster dose resulted in 71% additional seroconversion (17/24), with only patients using combination therapy not responding.ConclusionsHepA vaccination is highly immunogenic in virologically suppressed PLWH and patients on immunosuppressive monotherapy, with SCRs after the complete hepA vaccination schedule similar to controls and adequate booster responses in case of waning immunity. However, patients using immunosuppressive combination therapy as well as all ICPs who did not receive the complete hepA vaccination schedule, are at risk of non-response to vaccination and post-vaccination antibody measurements are recommended.

2

项与 Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.) 相关的新闻（医药）

2024-05-17

·GlobeNewswire-Health Care

Hepatitis: The silent killer

Safe vaccination, testing and treatment options widely availableJEFFERSON CITY, Mo., May 17, 2024 (GLOBE NEWSWIRE) -- May is Hepatitis Awareness Month, the perfect time for individuals to talk to their health care providers about hepatitis vaccinations. Hepatitis is an inflammation of the liver caused by a virus. The liver is a vital organ that processes nutrients, filters the blood and fights infections. When the liver is inflamed or damaged, its function can be affected. In many cases, people who contract hepatitis do not show any symptoms and do not know they are infected. Receiving a hepatitis vaccination is the most effective way to protect oneself from contracting and spreading the virus. There are three common strains of hepatitis in the United States: hepatitis A, hepatitis B and hepatitis C. Vaccines are available for both hepatitis A and hepatitis B, whereas hepatitis C is generally curable with treatment. Hepatitis A: Is spread when someone ingests the virus through close, personal contact with an infected person, or by eating contaminated food or drink. The hepatitis A vaccine is available and requires two doses, given six months apart. Receiving both doses provides the best protection. Hepatitis B: Is spread when bodily fluids from a person infected with the hepatitis B virus enter the body of someone who is not infected. The hepatitis B vaccine is available for all age groups, given as a series of two, three or four doses. There is also a vaccine available that protects adults from both hepatitis A and hepatitis B. This combined vaccine is usually given as three separate doses over a six-month period. Both the hepatitis A and hepatitis B vaccines are safe and proven effective. Hepatitis C: Is spread when blood from a person infected with the hepatitis C virus enters the body of someone who is not infected. Although there is no vaccine, it is curable in more than 95% of cases. Individuals are encouraged to talk to their health care provider about testing for hepatitis C. For those ages 18 and up in the Jefferson City area, the Missouri Department of Health and Senior Services is hosting a free hep C testing event from 11 a.m. to 1 p.m. CST on Monday, May 20 on the South Lawn of the Capitol. Most health insurance plans cover these vaccines. Families should check with their insurance provider on potential costs and where to get the vaccines. The Vaccines for Children Program, funded by the CDC, provides free vaccines to children who qualify. Parents or guardians can talk with a provider to determine eligibility. Additionally, most local public health agencies throughout the state of Missouri offer vaccinations at affordable rates. To find a local public health agency near you and schedule an appointment, visit the Local Public Health Agency Directory. Mission of the Missouri Department of Health and Senior Services (DHSS): To promote health and safety through prevention, collaboration, education, innovation and response. MEDIA CONTACT:Lisa CoxMissouri Department of Health and Senior ServicesMedia Inquiry Form

疫苗

2021-05-14

·Beckers Hospital Review

Beyond COVID-19 shots, many Americans aren't keeping up with routine vaccinations

Vaccination rates for non-COVID-related shots are still low among U.S. adults, according to a CDC study released May 14. The study examined vaccination data from 2017-2018. It found that about 46 percent of Americans age 19 and older received a flu vaccine. Less than 32 percent got a Tdap vaccine, which protects against tetanus, diphtheria and pertussis, and less than 12 percent received a hepatitis A vaccine. White Americans were more likely to be up to date with their vaccinations than people of color. This trend persisted even among healthcare providers, as white providers were generally more likely to have received their flu, Tdap and hepatitis B vaccines.

疫苗

100 项与 Hepatitis A vaccine(Boryung Pharmaceutical Co., Ltd.) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB10989

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
甲型肝炎	临床3期	韩国	Boryung Biopharma Co., Ltd.	2022-12-01
甲型肝炎	临床3期	泰国	Boryung Biopharma Co., Ltd.	2022-12-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ACR2023	N/A	克罗恩病 \| 幼年特发性关节炎	-	Hepatitis A vaccine (HAV Pediatric 80 antigen units)	範顧壓網選窪壓淵蓋簾(製齋餘醖鏇艱蓋餘鏇鏇) = Adverse events were reported by 2/16 participants after the first dose. All adverse events resolved without sequelae. No serious adverse events were reported. 網積鑰鑰構簾襯壓築窪 (製壓築鏇鑰淵網蓋蓋襯 )	-	2023-11-14
				Hepatitis A vaccine (HAV 160 antigen units)
Tandem Meetings ASTCT and CIBMTR2017	N/A	多发性骨髓瘤	-	Haemophilus influenzae type b (Hib) vaccine	醖願鹹範艱製鏇膚鏇願(壓蓋選廠艱觸淵壓範醖) = No patients had any adverse events 繭選觸獵積鏇餘鹹壓觸 (願網憲艱廠觸鬱獵簾選 )	-	2017-03-01
				Pneumococcal vaccine (Prevnar 13)
EULAR2015	N/A	自身炎症性疾病	28	HEPATITIS A VACCINE (Patients with auto-inflammatory disorders)	(築鹽憲範齋憲繭獵壓獵) = 鹽選遞製淵製積鏇憲獵鑰鏇積餘蓋蓋淵範網糧 (觸鏇糧窪鬱襯蓋齋選糧 ) 更多	-	2015-06-10
				HEPATITIS A VACCINE (Healthy controls)	(築鹽憲範齋憲繭獵壓獵) = 齋糧鹹餘蓋顧範憲繭遞鑰鏇積餘蓋蓋淵範網糧 (觸鏇糧窪鬱襯蓋齋選糧 ) 更多
EULAR2015	N/A	Crouzon综合征伴黑棘皮症	28	Hepatitis A vaccine (PFAPA patients)	(構製艱鏇選顧選憲簾襯) = 鹹憲選遞壓簾鏇蓋鹹糧衊窪鏇獵築夢製鬱壓壓 (憲衊積蓋衊選鏇願糧艱 ) 更多	-	2015-06-10
				Hepatitis A vaccine (Healthy controls)	(構製艱鏇選顧選憲簾襯) = 鬱築築鬱獵淵衊繭網膚衊窪鏇獵築夢製鬱壓壓 (憲衊積蓋衊選鏇願糧艱 ) 更多