Phase III, Randomized, Single-blind, Placebo-controlled, Multi-center Study to Evaluate Non-interference of Concomitant Administration of Routine Pediatric Vaccines on the Antibody Response of an Investigational Live-attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Infants and Toddlers (CORAL)

This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine [Vaxelis® or Pentacel® and Recombivax HB®] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.

开始日期2024-05-13

申办/合作机构

Sanofi Pasteur SA

NCT03893448

/ Completed临床3期

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)

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

开始日期2019-06-19

申办/合作机构

Merck Sharp & Dohme Corp.

NCT03620162

/ Completed临床3期

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

开始日期2018-10-18

申办/合作机构

Merck Sharp & Dohme Corp.

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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项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的文献（医药）

2024-09-01·CLINICAL TRANSPLANTATION

Hepatitis B Vaccine Compliance, Serologic Response, and Durability in Adult Thoracic Organ Transplant Recipients

Article

作者: Brumble, Lisa M. ; Beam, Elena ; Chiu, Chia‐Yu ; Vikram, Holenarasipur R. ; Watt, Kymberly D. ; Sampathkumar, Priya

ABSTRACT:

Introduction:

Hepatitis B virus (HBV) vaccination is recommended for solid organ transplant (SOT) candidates. However, there is a lack of data on the HBV vaccine compliance, serologic response, and durability of HBV seroprotection in thoracic organ transplantation recipients.

Methods:

We conducted a retrospective study of adult thoracic organ (heart and lung) transplant candidates who received HBV vaccination at Mayo Clinic sites in Minnesota, Arizona, and Florida between January 2018 and August 2023. Conventional recombinant hepatitis B vaccine (Recombivax HB) was used before 2020, and Heplisav‐B was preferred after 2020. HBV seroprotection was defined as hepatitis B surface antibody (HBsAb) ≥ 10 IU/L. Furthermore, we compared characteristics between recipients who maintained HBV seroprotection and those who lost HBV seroprotection (HBsAb < 10 IU/L) at 30 days posttransplantation (D30).

Results:

Among 922 candidates who were eligible for HBV vaccination, 430 (47%) completed the HBV vaccine series. Patients receiving Heplisav‐B were more likely to complete the series than Recombivax HB (81% vs. 60%, p < 0.001) and Heplisav‐B had a higher seroprotection rate than Recombivax HB (75% vs. 64%, p = 0.023). Multivariate logistic regression analysis identified receiving Heplisav‐B as an independent predictor for HBV seroprotection (adjusted odds ratio [aOR] 1.723; 95% confidence interval [CI] 1.056–2.810; p = 0.029). A total of 145 thoracic organ transplant recipients achieved HBV seroprotection at the date of transplantation. Loss of HBV seroprotection occurred in 38 (26%) patients at D30. Multivariate logistic regression analysis identified two predictors for HBV seroprotection loss at D30: age ≥ 60 years (aOR, 2.503; 95% CI 1.026–6.107; p = 0.044), and pretransplant HBsAb level between 10 and 100 IU/L (aOR, 18.575; 95% CI 5.211–66.209; p < 0.001).

Conclusions:

Although less than half of thoracic organ transplant candidates completed HBV vaccine series pretransplant, Heplisav‐B provided a higher vaccine completion rate and seroprotection than the 3‐dose Recombivax HB. Clinicians should also be aware of the increased loss of HBV seroprotection in thoracic organ transplant recipients with age ≥ 60 years and pretransplant HBsAb between 10 and 100 IU/L. Assessment of seroprotection after HBV vaccination should be prioritized during the pretransplant period.

2021-10-01·Vaccine3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: Fischetti, Briann ; Bakshi, Anjali ; Cope, Rebecca ; Berkowitz, Leonard ; Khaimova, Rebecca

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.

2021-01-01·Blood purification4区 · 医学

Hepatitis B Vaccination Response in Hemodialysis Patients: The Impact of Dialysis Shift

4区 · 医学

Article

作者: Thijssen, Stephan ; Rao, Sharon ; Ye, Xiaoling ; Maddux, Franklin W ; Hymes, Jeffrey ; Williams, Schantel ; Kotanko, Peter ; Han, Maggie

Background/Aims: Hepatitis B (HB) vaccination in hemodialysis patients is important as they are at a higher risk of contracting HB. However, hemodialysis patients have a lower HB seroconversion rate than their healthy counterparts. As better sleep has been associated with better seroconversion in healthy populations and early hemodialysis start has been linked to significant sleep-wake disturbances in hemodialysis patients, we examined if hemodialysis treatment start time is associated with HB vaccination response. Methods: Demographics, standard-of-care clinical, laboratory, and treatment parameters, dialysis shift data, HB antigen status, HB vaccination status, and HB titers were collected from hemodialysis patients in Fresenius clinics from January 2010 to December 2015. Patients in our analysis received 90% of dialysis treatments either before or after 8:30 a.m., were negative for HB antigen, and received a complete series of HB vaccination (Engerix B® or Recombivax HB™). Univariate and multivariate regression models examined whether dialysis start time is a predictor of HB vaccination response. Results: Patients were 65 years old, 57% male, and had a HD vintage of 10 months. Patients whose dialysis treatments started before 8:30 a.m. were more likely to be younger, male, and have a greater dialysis vintage. Patients receiving Engerix B® and starting dialysis before 8:30 a.m. had a significantly higher seroconversion rate compared to patients who started dialysis after 8:30 a.m. Early dialysis start was a significant predictor of seroconversion in univariate and multivariate regression including male gender, but not in multivariate regression including age, neutrophil-to-lymphocyte ratio, and vintage. Conclusion: While better sleep following vaccination is associated with seroconversion in the general population, this is not the case in hemodialysis patients after multivariate adjustment. In the context of end-stage kidney disease, early dialysis start is not a significant predictor of HB vaccination response. The association between objectively measured postvaccination sleep duration and seroconversion rate should be investigated.

项与 Hepatitis B vaccine(Merck Sharp & Dohme) 相关的新闻（医药）

2025-02-19

·FierceBiotech

Deep Track nominates candidates for Dynavax\'s board, launching proxy fight to end company\'s \'empire-building\' strategy

Deep Track Capital, which owns about 13.5% of Dynavax\'s stock, is launching a proxy fight to steer the company\'s resources toward approved hepatitis B vaccine Heplisav.\n After privately vying for a change to Dynavax’s corporate strategy for months, life sciences investment firm Deep Track Capital is publicly launching a proxy fight in a bid to steer the company in a new direction.Deep Track has nominated four directors to Dynavax’s board and sent a letter to other shareholders Feb. 19 announcing its intention to refocus the company’s efforts to its sole approved asset, hepatitis B vaccine Heplisav, rather than what Deep Track calls a “misguided empire-building exercise” of pursuing external asset acquisitions.Deep Track’s senior members first invested in Dynavax about 15 years ago to support the development of Heplisav, according to the letter, and the firm currently owns about 13.5% of Dynavax’s shares.Deep Track outlined several concerns about Dynavax’s current board, which now has 11 members but will drop back down to the previous head count of nine after the elections at the company’s upcoming 2025 annual meeting.These concerns include the fact that none of the board members up for election, including Chairman Scott Myers, has ever purchased Dynavax stock on the open market; that Myers also serves as chairman of three other biotech companies; and that Dynavax staggers board elections rather than putting every member up for election at once.Deep Track’s four proposed candidates include the firm’s managing director Brett Erkman as well as three independent biotech execs: Jeffrey Farrow, chief financial officer at Tarsus Pharmaceuticals; Michael Mullette, interim CEO at Lykos Therapeutics; and Donald Santel, former president and CEO of Hyperion Therapeutics.“In our view, the board’s unwillingness to compromise, coupled with the urgency of addressing the risk that the company squanders its cash, warrants this level of change,” Deep Track wrote.Since 2021, Dynavax’s board has instructed management to seek out external assets to purchase, Deep Track detailed in the letter. However, “these efforts have yielded nothing, and we believe continuing this effort will only further distract management from growing Heplisav,” the investment firm said.Dynavax came out with a lengthy statement and attacked Deep Track Wednesday night. In the release, the biopharma said that the firm, \"and in particular its founder, David Kroin, have become fixated on a strategy for Dynavax based on significantly flawed financial and strategic assumptions.\" It said that whilst it had been attempting to work with Deep Track, the firm had instead been \"insistent on a value destructive plan,\" that included \"abandoning portfolio diversification\" and running what it called a \"strip-mining plan.\"That plan is being seen through, Dynavax argues, by this attempted change of board members. The company argues that it already has since August been seeking out new directors \"as part of its ongoing refreshment program.\" The biopharma added that Deep Track initially proposed three new directors, but that Dynavax only saw one as being \"additive to the Board.\" Dynavax said its board sees the proxy contest as \"unreasonable,\" but that it still \"remains committed to constructive and reasonable engagement with Deep Track, while ensuring that the best interests of all stockholders—not only those of Mr. Kroin and his fund—are protected and represented.\" Heplisav was approved in 2017 and is projected to generate more than $1 billion through 2030, according to Deep Track. Dynavax has two other vaccines currently in development: a wholly owned vaccine for shingles and a Department of Defense-partnered vaccine for plague. Deep Track made no mention of either candidate in its letter.Another early-stage asset, a combination vaccine for tetanus, diphtheria and acellular pertussis, was dropped in November 2024 after phase 1 data failed to impress.Last month, Dynavax revealed changes to its board that it said were part of a \"refreshment program.\" These include appointing Emilio Emini, Ph.D., and Lauren Silvernail to the board as well as seeking shareholder approval to phase out Dynavax\'s staggered board elections.Deep Track called these changes \"reactive,\" noting that Silvernail is connected to Myers through Harpoon Therapeutics just like the board member she is replacing, Julie Eastland. The firm also expressed concern that changes to the board\'s election structure, so that all board seats come up for election at the same time, won\'t be fully implemented until 2028.Dynavax reports its full-year 2024 results Feb. 20.

$Deep Track nominates candidates for Dynavax\'s board, launching proxy fight to end company\'s \'empire-building\' strategy$

疫苗高管变更IPO

2025-01-27

·PRNewswire

Dynavax Advances Board Refreshment Program

Appoints Emilio Emini and Lauren Silvernail to Board of Directors; Two Directors to Step Down at 2025 Annual Meeting Intends to Seek Stockholder Approval for Declassification of Board at 2025 Annual Meeting EMERYVILLE, Calif., Jan. 27, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) (the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced the following changes to its Board of Directors as part of its ongoing refreshment program: Emilio Emini, Ph.D. and Lauren Silvernail have been appointed to the Board, effective February 3, 2025. Dr. Emini will serve as a Class III director with an initial term expiring at the Company's 2027 Annual Meeting and Ms. Silvernail will serve as a Class I director with an initial term expiring at the Company's 2025 Annual Meeting. Peggy Phillips, who has served on the Dynavax Board since 2006, will retire from the Board at the 2025 Annual Meeting. Julie Eastland will step down from the Board at the 2025 Annual Meeting given her recent appointment as chief executive officer of another public company. The Board expects to appoint Ms. Silvernail as Chair of the Audit Committee and Scott Myers as Chair of the Compensation Committee following the 2025 Annual Meeting. The Board intends to seek stockholder approval at the 2025 Annual Meeting for the declassification of the Board. If stockholders approve the proposal, directors standing for election at the Company's 2026 Annual Meeting and thereafter will stand for one-year terms. Beginning with the Company's 2028 Annual Meeting, all directors will stand for election annually. Following the 2025 Annual Meeting, the Board will be comprised of nine directors, with six of its eight independent directors having been appointed since 2020. "Emilio and Lauren are two renowned leaders in their respective fields and we expect that their tremendous expertise will be immediately additive as the Company continues to execute its strategic plan and deliver for our stakeholders. Emilio has been at the forefront of some of the most notable vaccines and brings a unique perspective at the intersection of R&D, academia and public health and Lauren brings a track record of financial and operational prowess and board leadership experience within the biopharma space," said Scott Myers, Chairman of the Dynavax Board of Directors. "On behalf of the Board, I want to extend my gratitude to Peggy and Julie who have made innumerable contributions to Dynavax's growth and success over the years. Our ongoing efforts to refresh our Board with fresh perspective and expertise and enhance our governance profile are key pillars of our commitment to support Dynavax's long-term growth objectives and the changes announced today underscore this commitment." Dr. Emini said, "Dynavax has an important mission, one that I firmly share, and I am excited to work alongside the Board and the Dynavax team, a group of world-class innovators and scientists serving patients globally." Ms. Silvernail said, "Dynavax is a clear category leader with its lead asset, HEPLISAV-B, and I am eager to work with the Board to help advance the Company's strategic and financial initiatives to capitalize on its positive momentum." "We have started 2025 with strong momentum, achieving record annual revenue for HEPLISAV-B in 2024 and advancing our pipeline programs, while returning capital to our stockholders with our active $200 million share repurchase program. Through the execution of our strategic growth pillars with discipline and rigor, we will continue to focus on delivering value for our stockholders and other stakeholders, and I am looking forward to working alongside Emilio and Lauren as we look to capture the significant opportunities ahead," said Ryan Spencer, Chief Executive Officer of Dynavax. About Emilio Emini Dr. Emini brings over 40 years of experience as an executive and academic across the biopharmaceutical industry and global public health roles, helping to develop and deliver multiple anti-infectious disease interventions. Prior to his retirement, Dr. Emini served as Chief Executive Officer of the Bill & Melinda Gates Medical Research Institute and as the Director of the Foundation's Tuberculosis and HIV Programs. At the Merck Research Laboratories, from 1983 to 2004, Dr. Emini led the biological research that developed the first highly active antiretroviral therapies for HIV and led multiple vaccine research teams that contributed to many successful developments, including the vaccines for human papillomavirus and rotavirus. Following a two-year leave from the industry at the International AIDS Vaccine Initiative, Dr. Emini joined Wyeth/Pfizer as the Senior Vice President of Vaccine R&D where he led the development of the Prevenar 13® vaccine for prevention of pneumococcal disease. Dr. Emini holds a Bachelor of Science from Manhattan College and a Ph.D. in Microbiology from the Cornell University Graduate School of Medicine. About Lauren Silvernail Ms. Silvernail has three decades of experience leading finance and business development functions across the pharmaceutical industry. She most recently served as Chief Financial Officer and Executive Vice President of Corporate Development of Evolus, Inc., from 2018 until her retirement in 2022, where she led fundraising, financial and partnership activities including establishing the infrastructure for the U.S. commercial launch of the company's first approved product. Previously, she served as Chief Financial Officer and Chief Business Officer at Revance Therapeutics, Inc., where she led the company's initial public offering and subsequent rounds of financing. Prior to that, Ms. Silvernail was Chief Financial Officer and Executive Vice President of Corporate Development at ISTA Pharmaceuticals until its sale to Bausch & Lomb. Prior to that, she held corporate development roles at Allergan and other companies. Ms. Silvernail is currently a director and Audit Committee Chair of Harrow and previously served as a director and Audit Committee Chair at Harpoon Therapeutics until its successful sale to Merck and a director and Corporate Governance Committee chair at Nicox S.A. She earned an M.B.A. in finance and accounting from the Anderson Graduate School of Management at UCLA, and a B.A. in Biophysics from the University of California, Berkeley. About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding the Company's plans to submit a declassification proposal at its 2025 Annual Meeting, expected contributions from newly appointed directors, the planned resignation of certain directors, anticipated committee appointments, expectations regarding delivering value for our stockholders, and our future growth and long-term performance. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that circumstances surrounding or leading up to our 2025 Annual Meeting may change, risks relating to our ability to commercialize and supply HEPLISAV-B, and risks related to the implementation of our long-term growth objectives, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended September 30, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in our current periodic reports with the SEC. For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

疫苗高管变更

2024-11-22

·健识局

美国乙肝疫苗公司破产，绊倒中国创新药企

11月15日，VBI Vaccines宣布：公司破产终止运营，将在全美范围内召回乙肝疫苗PreHevbrio。 VBI是一家纳斯达克上市公司，PreHevbrio是其开发的一款第三代预防性成人乙肝疫苗，2021年11月登陆美国市场，是VBI 唯一一款上市产品。今年7月VBI 申请破产，意味着PreHevbrio也将成为无本之木。原本只是一则大洋彼岸的消息，却意外牵连到一家国内创新药公司。去年7月，港股上市公司腾盛博药引进PreHevbrio在大中华区及澳大利亚、新加坡等亚太国家的独家开发和商业化权益，同时，将此前引进的一款乙肝治疗性疫苗BRII-179的权益扩大到全球市场，为此还付给VBI公司700万美元首付款。从一家濒临破产的公司引进产品，这在国内医药史上还不多见。腾盛博药在VBI宣布破产后，双方合作还会如何开展？ 11月19日，腾盛博药回应健识局称：撤回是因对方公司破产和运营终止，而非产品问题。不过，腾盛博药不会进一步开发PreHevbrio。若未来有其他公司接手该项目，将重新评估是否继续推进该产品。对于BRII-179，公司正独立开展研发，预计VBI的破产不会对BRII-179的临床开发产生影响。双方捆绑颇深 PreHevbrio是美国市场上获批的唯一一款靶向3种乙肝病毒抗原的预防性成人乙肝疫苗，已经在美国、英国、加拿大、欧盟等地区上市。尽管产品具有一定突破性，但奈何竞争对手过于强大。PreHevbrio的竞争对手是默沙东、GSK开发的Recombivax-HB、Engerix-B这两款成功使用了近四十年的重组疫苗、以及2001年上市的GSK开发的世界上唯一一种甲肝、乙肝混合肝炎疫苗Twinrix。 PreHevbrio的销售成绩可以用惨烈来形容。2022年进入市场后，当年销售额110万美元；第二年销售额不过310万美元。直到退市，VBI都没能触动“疫苗四巨头”控制的市场。 VBI公司另一款在研产品治疗性乙肝疫苗BRII-179，倒是可能有市场价值。但因为公司破产，研发停止，所有预期都成了泡影。腾盛博药为何会看上这样一家公司？腾盛博药也是一家专注于乙肝领域创新疗法的研发公司，2018年由前GSK高级副总裁、感染性疾病治疗领域部门负责人洪志博士创立，2021年凭借首个国产新冠中和抗体安巴韦单抗/罗米司韦单抗出过风头。腾盛博药可能并不是特别看重乙肝疫苗PreHevbrio。此次最新的对外口径中，腾盛博药明确不再自主开发PreHevbrio。治疗性乙肝疫苗BRII-179吸引力会更大一些。2018年12月，腾盛博药从VBI引进BRII-179，获得了其在大中华区的商业化权益。此后，BRII-179与腾盛博药从Vir引进的siRNA药物BRII-835一道，成为腾盛博药在乙肝领域的两款核心管线。腾盛博药与VBI的捆绑比较紧密，除了合作推进BRII-179单药在许可区域的临床外，2021年12月，腾盛博药还与VBI签订补充协议，开展额外的联合用药临床试验。同时，腾盛博药还认购了VBI部分股份。2023年7月，腾盛博药进一步获得BRII-179的全球权益。到今年2月，腾盛博药可能预见到合作公司情势不妙，为了消除后患，进一步包揽了BRII-179的所有权益，包括知识产权、以及VBI在以色列的生产设施，同时附加了一款癌症疫苗VBI-1901在亚太地区（除日本外）的市场权益，交易总金额最高3300万美元。当时外媒报道称，这笔交易为VBI减少了70%的债务负担，但VBI的破产已无可挽回。今年7月，知悉VBI的破产，腾盛博药发布公告：公司自2024年2月起就一直与VBI密切合作，致力于将BRII-179的生产能力平稳转移至第三方合同开发和生产商。目前该技术转移正在进行中，预计VBI的破产不会对BRII-179的临床开发产生影响。近期，腾盛博药进一步回应健识局称，目前BRII-179所有中国及海外的临床试验均由腾盛博药独立开展进行，无需VBI任何参与。同时，公司也为BRII-179的临床研究确保了稳定的临床供应。艰难乙肝治愈路腾盛博药一路加持VBI公司，可能是因为两家公司有颇多相似之处。双方都在成立初期大手笔投入新冠疫苗、药物的研发：VBI曾将三种候选新冠疫苗管线推进到临床研究，尽管因各种原因都未能上市。腾盛博药为“首个国产新冠中和抗体”投入2亿美元。此外，腾盛博药与VBI一样，都将实现乙肝功能性治愈作为公司使命。乙肝市场颇为庞大，仅在中国，就有8700万感染者，目前，乙肝还没有有效的治愈办法，长效干扰素的临床治愈率仅有3%-8%，且副作用很大，很多患者无法耐受。治愈乙肝看似目标不大，其实是全球大牌药企都没能达到的终点。去年，VBI裁员30%-35%，并削减管线，表示要专注于推进BRII-179，最终落得破产的地步。腾盛博药现在还没有近忧，根据年报，公司目前手握20多亿元现金，足以支撑运营到2027年。不过，腾盛博药在资本市场的表现并不乐观。去年2月初，马云、云峰基金、美国投资公司等一系列股东纷纷减持，引发公司股价下跌。今年2月15日，腾盛博药宣布，BRII-835与BRII-179联合疗法用于治愈乙型肝炎病毒（HBV）感染II期研究取得了积极的中期结果，但未能获得市场认可，股价继续暴跌。目前，公司股价不过1.04港元，与52.6港元的历史高点相距甚远。目前，腾盛博药还在和合作伙伴Vir开展各种联合治疗方案的临床研究，除了BRII-835和BRII-179外，还有BRII-179+长效干扰素、BRII-835+长效干扰素等等，但就已经公布的前期结果来看，没有一个接近大规模治愈。这些II期临床还在继续推进，腾盛博药告诉健识局，期待在明年获得更多的研究数据，为未来3期临床试验提供策略依据。撰稿丨李傲编辑丨江芸贾亭运营｜山谷插图｜视觉中国声明：健识局原创内容，未经许可请勿转载 “减肥神药”线上预约新模式，医药电商竞争迎来新变局感冒拍个CT就要花六百？影像检查即将降价新事 | 有媒体称默沙东中国糖尿病业务部门裁员

引进/卖出疫苗siRNA

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
-	-	J07BC01	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
乙型肝炎	美国	Merck & Co., Inc.	1986-07-23

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肝细胞癌	临床2期	-	Merck Sharp & Dohme Corp.	2006-05-01
白喉	临床2期	加拿大	Sanofi Pasteur SA	1999-01-01
脊髓灰质炎	临床2期	加拿大	Sanofi Pasteur SA	1999-01-01
破伤风	临床2期	加拿大	Sanofi Pasteur SA	1999-01-01
百日咳	临床2期	加拿大	Sanofi Pasteur SA	1999-01-01
HIV感染	临床1期	美国	Protein Sciences Corp.	2001-08-31

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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


NCT02429583 (CTgov)	临床4期	丙型肝炎 \| 慢性丙型肝炎	24	Recombivax (Recombivax in HCV Infected Individuals)	願製憲衊醖築淵鹽膚醖(網襯鹹膚餘蓋鑰壓網艱) = 鏇簾願築襯餘鏇製膚廠鹽鬱鬱壓積遞鏇艱觸廠 (淵鑰衊鹽艱淵範襯齋願, 願夢齋淵願壓衊齋顧鑰 ~ 範鹹鹽齋夢選選窪淵夢) 更多	-	2020-03-04
				Recombivax (Recombivax in Healthy Volunteers)	願製憲衊醖築淵鹽膚醖(網襯鹹膚餘蓋鑰壓網艱) = 鹽選網鑰製觸夢鑰廠襯鹽鬱鬱壓積遞鏇艱觸廠 (淵鑰衊鹽艱淵範襯齋願, 憲窪襯顧鬱簾夢觸廠襯 ~ 構糧製鹽遞製艱構範壓) 更多
NCT01463683 (V232-062, CTgov)	临床3期	乙型肝炎	722	2XP HEPTAVAX™-II SC (V232-2XP SC)	淵觸觸窪壓艱壓遞鏇積 = 遞齋鬱醖鑰窪顧範淵齋獵構醖網繭鬱鏇選衊範 (齋遞網願醖鹽餘築願製, 鹹餘糧鑰襯衊簾獵鏇築 ~ 壓蓋廠齋淵餘醖繭蓋窪) 更多	-	2014-02-17
				HEPTAVAX™-II (V232-1XP SC)	淵觸觸窪壓艱壓遞鏇積 = 製鬱繭構繭顧窪襯鹹鹹獵構醖網繭鬱鏇選衊範 (齋遞網願醖鹽餘築願製, 簾齋壓選觸衊鹹襯鏇網 ~ 鹹築鏇製鑰襯顧蓋憲齋) 更多
NCT00440531 (Pubmed)	临床3期	-	538	hepatitis B vaccine (mpHBV)	鏇膚窪鏇壓廠鏇醖壓夢(襯衊積餘鹽繭鑰鑰醖糧) = There were 6 non-vaccine related serious adverse events reported 範齋範鑰鹽鏇簾憲構繭 (製觸鑰網簾鹹淵獵糧製 )	-	2011-12-01
				hepatitis B vaccine (RECOMBIVAX-HB)
IAS2010	N/A	HIV感染	48	hepatitis B vaccination (Double dose HBV vaccination)	淵製願齋鹹蓋壓獵鬱製(齋窪憲獵膚壓衊蓋衊憲) = 憲鹹廠鬱艱蓋顧艱積繭繭窪鑰醖願醖醖蓋網鑰 (鑰膚鏇簾艱襯鬱願鑰遞 )	-	2010-01-01
NCT00393523 (V232-058, CTgov)	临床3期	乙型肝炎	1,478	Hepatitis B Vaccine (Modified Process Hepatitis B Vaccine Booster (Group 1))	糧艱醖鑰衊選鏇膚簾窪 = 鹽構鹹獵顧簾夢鹹範壓壓齋淵鬱築獵顧構網淵 (淵夢繭簾顧襯憲鹽膚鹹, 觸網醖淵糧簾艱繭憲選 ~ 窪繭觸壓選夢艱鹹顧網) 更多	-	2009-10-12
				ENGERIX-B+RECOMBIVAX-HB (ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2))	糧艱醖鑰衊選鏇膚簾窪 = 糧膚製網鏇鬱襯積範鬱壓齋淵鬱築獵顧構網淵 (淵夢繭簾顧襯憲鹽膚鹹, 獵繭憲鏇繭糧願壓壓選 ~ 選膚醖範糧窪淵鏇鹽憲) 更多
NCT00414050 (V232-057, CTgov)	临床3期	乙型肝炎	1,718	Hepatitis B Vaccine (Recombinant)	齋廠範糧壓築醖壓築窪 = 鬱夢遞遞鏇醖齋廠夢鹽鏇網繭願簾繭蓋簾顧遞 (遞憲積襯窪壓範糧鏇窪, 鑰醖膚簾構願願選蓋觸 ~ 網壓簾鹹簾窪膚製鬱蓋) 更多	-	2009-04-14
NCT00440531 (V232-059, CTgov)	临床3期	乙型肝炎	540	Hepatitis B Vaccine (Modified Process Hepatitis B Vaccine)	糧鏇淵廠範顧範積繭夢 = 衊襯製壓淵齋鑰憲膚夢襯憲鹽憲廠獵齋築廠夢 (壓壓壓糧餘構夢鏇顧選, 壓齋鑰繭觸鹹淵鬱淵繭 ~ 簾齋醖淵鏇壓糧襯蓋鏇) 更多	-	2009-03-31
				RECOMBIVAX-HB (RECOMBIVAX-HB™)	糧鏇淵廠範顧範積繭夢 = 積積壓襯網願鹹齋鹹艱襯憲鹽憲廠獵齋築廠夢 (壓壓壓糧餘構夢鏇顧選, 選鏇顧膚鑰積願餘淵膚 ~ 積襯選製衊膚願選鑰獵) 更多