Delving into the Latest Updates on Hepatitis B vaccine(Merck Sharp & Dohme) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Genetically engineered subunit vaccine

Synonyms

Hepatitis B Vaccine (Recombinant), Recombivax, Recombivax Hb, Heptavax-II

+ [1]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis B

Inactive Indication

DiphtheriaPoliomyelitisTetanus+ [1]

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Merck & Co., Inc.MSD KK

Inactive Organization

Sanofi Pasteur

Merck Sharp & Dohme Corp.

Novosanis NV

Drug Highest PhaseApproved

First Approval Date

US (23 Jul 1986),

Hepatitis B

Regulation-

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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.

Start Date13 May 2024

Sponsor / Collaborator

Sanofi Pasteur

NCT01463683 / CompletedPhase 3

A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process

This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.

Start Date29 Nov 2011

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

EUCTR2006-003650-20-GB / Not yet recruitingPhase 3

A Study in Renal Predialysis and Dialysis Patients of the Safety,Tolerability, and Immunogenicity of Recombinant Hepatitis BVaccine Manufactured with a Modified Process - Hepatitis B Vaccine (Recombinant) Dialysis Study

Start Date19 Feb 2007

Sponsor / Collaborator

Merck & Co., Inc.

100 Clinical Results associated with Hepatitis B vaccine(Merck Sharp & Dohme)

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100 Translational Medicine associated with Hepatitis B vaccine(Merck Sharp & Dohme)

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100 Patents (Medical) associated with Hepatitis B vaccine(Merck Sharp & Dohme)

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140

Literatures (Medical) associated with Hepatitis B vaccine(Merck Sharp & Dohme)

01 Jun 2024·Journal of the Formosan Medical Association

The seroepidemiology of isolated core antibody against hepatitis B among Taiwanese adults - A large hospital-based study

Article

Author: Kuo, Ting-Ya ; Jan, Chyi-Feng ; Chien, Yin-Chu ; Chang, Jerry Che-Jui

BACKGROUND/PURPOSEThis study aims to investigate the prevalence of isolated core antibodies against hepatitis B (IAHBc) in different birth cohorts using a large medical record database.METHODSHepatitis B viral serological test data were collected from a chart cloud database at a medical center in Taiwan between January 2006 and December 2018. The data collected included birth year, sex, hepatitis B viral markers (HBsAg, anti-HBs or anti-HBc), and hepatitis B vaccination records. Enrolled patients were grouped according to their birth year into three categories: ≤ 1986, 1987-1992, and ≥ 1993, which correspond to no neonatal hepatitis B immunization, plasma-derived HB vaccine (PDHBV), and recombinant hepatitis B vaccine (RHBV), respectively. Prevalence of hepatitis B viral seromarkers, including IAHBc, was calculated by sex, age groups, and birth cohorts. Those who underwent repeated hepatitis B serology tests were included for further analysis to follow up their serostatus.RESULTSA total of 117,335 adults with complete hepatitis B serologic data were analyzed. Among them, 6641 individuals (5.7 %) were found to have IAHBc. The prevalence of IAHBc was 11.4 %, 0.8 %, and 0.3 % among those born before 1986, between 1987 and 1992, and after 1992, respectively. Among the 690 subjects with repeated blood tests and complete hepatitis B serologic data, 551 cases (79.9 %) remained IAHBc. The other cases included resolved infection status (13.9 %), seronegativity for three HB seromarkers (3 %), and carrier of hepatitis B virus (2.3 %).CONCLUSIONThe management of individuals with IAHBc should be tailored to their age, vaccination status, and risk factors for occult hepatitis B viral infection.

01 Jun 2022·VaccineQ3 · MEDICINE

Adult immunization against hepatitis B: Does the number of jabs matter?

Q3 · MEDICINE

Article

Author: Ottino, Kevin ; Oster, Gerry ; Bornheimer, Rebecca ; Stevenson, Catherine ; Lewin, Clem ; Janssen, Robert

BACKGROUNDAt 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.OBJECTIVETo 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.METHODSDecision-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.RESULTSUse 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.CONCLUSIONSUse 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.

01 Oct 2021·VaccineQ3 · MEDICINE

Serological response with Heplisav-B® in prior Hepatitis B vaccine non-responders living with HIV

Q3 · MEDICINE

Article

Author: Fischetti, Briann ; Berkowitz, Leonard ; Bakshi, Anjali ; Khaimova, Rebecca ; Cope, Rebecca

BACKGROUNDAs 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.METHODSRetrospective, 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®.RESULTSA 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.CONCLUSIONSHeplisav-B® was highly effective in achieving immunity to HBV in PLWH who failed non-adjuvanted recombinant vaccines.

100 Deals associated with Hepatitis B vaccine(Merck Sharp & Dohme)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	US	Merck & Co., Inc.	23 Jul 1986

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B	Preclinical	-	Merck Sharp & Dohme Corp.	01 Sep 2006
Diphtheria	Preclinical	CA	Sanofi Pasteur	01 Jan 1999
Tetanus	Preclinical	CA	Sanofi Pasteur	01 Jan 1999
Whooping Cough	Preclinical	CA	Sanofi Pasteur	01 Jan 1999

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01463683 (V232-062, CTgov)	Phase 3	Hepatitis B	722	2XP HEPTAVAX™-II SC (V232-2XP SC)	voowtdxkxe(weccqzugld) = djvvcvqwsu rkbwgbxsye (pqzxcybtwz, ykhhxkdzlr - gxzlwkohlb) View more	-	17 Feb 2014
				1XP HEPTAVAX™-II SC (V232-1XP SC)	voowtdxkxe(weccqzugld) = plyagetecs rkbwgbxsye (pqzxcybtwz, bcurhncviz - soakjmwyhx) View more