更新于：2024-05-01
Hepatitis B vaccine(Merck Sharp & Dohme)
更新于：2024-05-01
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1986-07-23), |
最高研发阶段(中国)- |
特殊审评- |
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序列信息
Sequence Code 27367373
关联
8
项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的临床试验A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process
A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
100 项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的临床结果
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100 项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的转化医学
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100 项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的专利（医药）
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132
项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的文献（医药）2022-05-12Vaccine3区 · 医学
Adult immunization against hepatitis B: Does the number of jabs matter?
3区 · 医学
Article
作者: Gerry Oster ; Rebecca Bornheimer ; Kevin Ottino ; Catherine Stevenson ; Clem Lewin ; Robert Janssen
BACKGROUND:
At least one-half of adults beginning an immunization series with a three-dose hepatitis B virus (HBV) vaccine (ENGERIX-B, RECOMBIVAX-B) have been reported not to receive the third dose. Use of a two-dose vaccine may improve adherence and lead to greater overall levels of seroprotection.
OBJECTIVE:
To examine expected levels of adherence and overall seroprotection at one year among adults in routine clinical settings beginning an immunization series with either ENGERIX-B or the two-dose HBV vaccine, HEPLISAV-B.
METHODS:
Decision-analytic model comparing expected levels of adherence and overall seroprotection at one year among a hypothetical cohort of one million previously unvaccinated adults aged ≥ 30 years receiving first doses of either ENGERIX-B or HEPLISAV-B in a routine clinical setting. We stratified the population by age (30-49 years vs ≥ 50 years) to allow for possible differences in adherence and seroprotection. We estimated our model using published adherence rates for HBV vaccines, and reported seroprotection rates by number of doses administered. We also compared total expected costs of HBV immunization with each vaccine.
RESULTS:
Use of a two-dose rather than three-dose HBV vaccine would increase the expected number of adults seroprotected at one year by 275,000 per one million persons beginning immunization series, largely reflecting a gain of 290,000 in the expected number of persons fully vaccinated. Results were similar for the two age groups. While the cost per dose of HEPLISAV-B exceeds that of ENGERIX-B, its estimated mean cost per person seroprotected at one year is $50-$70 (∼15%) lower.
CONCLUSIONS:
Use of a two-dose HBV vaccine would increase the number of adults fully seroprotected at one year compared with the number expected with a three-dose vaccine. Notwithstanding its higher unit cost, mean expected cost per person seroprotected is substantially lower for HEPLISAV-B than ENGERIX-B as a result of much higher levels of seroprotection.
2021-09-29Vaccine3区 · 医学
Serological response with Heplisav-B® in prior Hepatitis B vaccine non-responders living with HIV.
3区 · 医学
Article
作者: Rebecca Khaimova ; Briann Fischetti ; Rebecca Cope ; Leonard Berkowitz ; Anjali Bakshi
BACKGROUND:
As people living with HIV (PLWH) are at risk for contracting Hepatitis B Virus (HBV), they should be screened for HBV and vaccinated if not immune. Seroconversion rates in PLWH receiving traditional recombinant HBV vaccines (Engerix-B® and Recombivax-HB®) have historically been low with at most 70% achieving immunity. In 2017, a recombinant, adjuvanted HBV vaccine (Heplisav-B®) was approved for use in HIV-negative patients. Heplisav-B® has shown superior seroprotection in this population compared to Engerix-B® and Recombivax-HB®, as well as interim analysis showing higher seropositivity rates in patients undergoing dialysis. However, its efficacy in PLWH is currently unknown. This study evaluates the rate of seroconversion following Heplisav-B® administration in PLWH with previous HBV vaccination failure.
METHODS:
Retrospective, cross-sectional study at The Brooklyn Hospital Center's HIV primary care clinic in Brooklyn, NY. HIV-positive adults who received at least two doses of Heplisav-B® and had previously failed to seroconvert after vaccination with Engerix-B® or Recombivax-HB® were included. The primary outcome is the percentage of PLWH who became seropositive following Heplisav-B®.
RESULTS:
A total of 67 patients met the inclusion criteria. Twenty-five (37.3%) PLWH had failed at least 2 courses of recombinant vaccines. Fifty-eight (86.6%) PLWH became seropositive (Anti-HBs > 10 mIU/mL) at least two months after completing Heplisav-B®. For the 9 (13.4%) patients that did not develop immunity, 3 (33%) had a detectable HIV RNA and 3 (33%) had a CD4 count < 200 cells/uL3.
CONCLUSIONS:
Heplisav-B® was highly effective in achieving immunity to HBV in PLWH who failed non-adjuvanted recombinant vaccines.
2021-03-15Indian pediatrics4区 · 医学
Three vs Four Dose Schedule of Double Strength Recombinant Hepatitis-B Vaccine in HIV-infected Children: A Randomized Controlled Trial.
4区 · 医学
Article
作者: Prachi Jain ; Pooja Dewan ; Sunil Gomber ; Bineeta Kashyap ; Alpana Raizada
OBJECTIVE:
To compare seroprotection rates and the anti-HBs titers following primary immunization with double strength (20 µg) recombinant hepatitis B virus (rHBV) vaccine administered intramuscularly (IM) in a 3-dose (0, 1 and 6 months) vs 4-dose (0, 1, 2 and 6 months) schedule in HIV-infected children receiving antiretroviral therapy (ART). An accelerated 3-dose schedule (0, 1, 2 months) within the 4-dose group was also compared.
DESIGN:
Randomized controlled trial.
SETTING:
Pediatric ART clinic of a tertiary hospital in Delhi from November, 2017 to April, 2019.
PARTICIPANTS:
Fifty (25 per group) HIV-infected children aged 18 months - 12 years receiving ART for at least 6 months who had not received any prior dose of HBV vaccine, and were anti-HBs negative.
Intervention:
Group 1 received 20 µg of rHBV vaccine IM (in deltoid muscle) at 0, 1, and 6 months, and group 2 received 20 µg the same vaccine at 0, 1, 2 and 6 months.
OUTCOME VARIABLES:
Anti-HBs titers and proportion of responders in 3-dose vs 4-dose group at seventh and twelfth month and at third month after an accelerated 3-dose schedule.
RESULTS:
Median (IQR) anti-HBs titers at the seventh month were significantly higher in group 2 [225.7 (151-300) IU/L] compared to group 1 [138.2 (35.2-250) IU/L], but were comparable at the 12th month. Seroprotection rates were comparable between group 2 and group 1 at 7th month (96% vs 80%; P=0.19) and 12th month (96% vs 88%; P=0.61). The proportion of good responders were also comparable between the groups at 7th month and 12th month (both P=0.29). Accelerated 3-dose schedule achieved comparable anti-HBs titers [179.9 (130.6-250) IU/L] and seroprotection rate (92%) one month after completion of schedule to the standard 3-dose + schedule.
CONCLUSIONS:
A 3-dose double strength recombinant HBV vaccine schedule offers comparable seroprotection to 4-dose schedule for HIV-infected children receiving ART.
100 项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| - | 批准上市 | 日本 更多 | MSD KK 更多 |
| 乙型肝炎 | 批准上市 | 美国 更多 | |
| 百日咳 | 无进展 | 加拿大 更多 | |
| 白喉 | 无进展 | 加拿大 更多 | |
| 破伤风 | 无进展 | 加拿大 更多 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 204 | (Modified Process Hepatitis B Vaccine in Base Study) | 窪窪衊網襯糧繭鹹範夢(憲遞遞獵鑰衊糧築蓋艱) = 鑰艱醖艱餘選憲鬱鑰遞 襯簾願憲鏇鹽範顧願艱 (憲繭廠簾糧鹽壓鹹壓糧, 獵襯簾艱築繭遞選積壓 ~ 糧餘齋網艱襯積範夢選) 更多 | - | 2017-08-28 | ||
(ENGERIX-B™ Vaccine in Base Study) | 窪窪衊網襯糧繭鹹範夢(憲遞遞獵鑰衊糧築蓋艱) = 膚襯鑰範製襯鑰鬱遞積 襯簾願憲鏇鹽範顧願艱 (憲繭廠簾糧鹽壓鹹壓糧, 積積壓衊憲範觸製餘糧 ~ 築築糧廠餘糧鬱膚糧蓋) 更多 | ||||||
临床3期 | 1,478 | (Modified Process Hepatitis B Vaccine Booster (Group 1)) | 鑰醖鹹衊築襯膚糧窪齋(範蓋簾鏇壓襯構廠範願) = 淵網艱顧壓繭築獵齋鏇 鹽遞艱鑰憲築憲範構淵 (鑰鏇鹽襯獵觸鬱繭鏇憲, 網醖網糧餘遞襯繭蓋鏇 ~ 鏇窪鬱網範願憲餘繭鹽) 更多 | - | 2009-10-12 | ||
(ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)) | 鑰醖鹹衊築襯膚糧窪齋(範蓋簾鏇壓襯構廠範願) = 遞願構願糧蓋製網艱膚 鹽遞艱鑰憲築憲範構淵 (鑰鏇鹽襯獵觸鬱繭鏇憲, 願獵獵鹽廠願糧艱鏇鬱 ~ 艱鹹鹽壓淵齋積製夢壓) 更多 | ||||||
临床3期 | 1,718 | 願糧壓艱夢艱鹽夢鏇選(觸憲積夢齋積製夢醖襯) = 鬱壓衊獵襯壓製鬱襯鏇 衊鏇襯廠遞築製築製醖 (餘夢獵獵遞鏇積蓋願獵, 餘鹹窪廠積繭憲夢遞壓 ~ 鹹糧網顧築艱窪觸觸壓) 更多 | - | 2009-04-14 | |||
临床3期 | 1,720 | (觸廠糧網積膚遞網鬱顧): Percentage Point Difference = -4.8 (95.0% CI, -9.3 ~ -0.2); Percentage Point Difference = -0.4 (95.0% CI, -4.6 ~ 3.7); Percentage Point Difference = 2.9 (95.0% CI, -1.9 ~ 7.6); Percentage Point Difference = 2.4 (95.0% CI, -1.7 ~ 6.5) 更多 | - | 2022-03-25 | |||
(Prevnar 13™) |
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